Standard-Compliant Risk Assessment. Implementation in Accordance with EN ISO and EN ISO 12100:2010. Safety Integrated

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3 Standard-Compliant Risk Assessment Implementation in Accordance with EN ISO and EN ISO 12100:2010 Safety Integrated Standard-Compliant Risk Assessment Implementation in Accordance with EN ISO and EN ISO 12100:2010 Reference Manual General 1 CE Conformity Process in 9 Phases 2 Notes on Risk Assessment Implementation 3 Reevaluation of Realized Safety-Related Control 4 Systems Further Information 5 Terms and Definitions 6 Important Type-A and Type-B Standards 7 Internet Links 8 Important Addresses 9 Document History /2011

4 Legal information Legal information Warning notice system This manual contains notices you have to observe in order to ensure your personal safety, as well as to prevent damage to property. The notices referring to your personal safety are highlighted in the manual by a safety alert symbol, notices referring only to property damage have no safety alert symbol. These notices shown below are graded according to the degree of danger. DANGER indicates that death or severe personal injury will result if proper precautions are not taken. WARNING indicates that death or severe personal injury may result if proper precautions are not taken. CAUTION with a safety alert symbol, indicates that minor personal injury can result if proper precautions are not taken. CAUTION without a safety alert symbol, indicates that property damage can result if proper precautions are not taken. NOTICE indicates that an unintended result or situation can occur if the relevant information is not taken into account. If more than one degree of danger is present, the warning notice representing the highest degree of danger will be used. A notice warning of injury to persons with a safety alert symbol may also include a warning relating to property damage. Qualified Personnel The product/system described in this documentation may be operated only by personnel qualified for the specific task in accordance with the relevant documentation, in particular its warning notices and safety instructions. Qualified personnel are those who, based on their training and experience, are capable of identifying risks and avoiding potential hazards when working with these products/systems. Proper use of Siemens products Note the following: WARNING Siemens products may only be used for the applications described in the catalog and in the relevant technical documentation. If products and components from other manufacturers are used, these must be recommended or approved by Siemens. Proper transport, storage, installation, assembly, commissioning, operation and maintenance are required to ensure that the products operate safely and without any problems. The permissible ambient conditions must be complied with. The information in the relevant documentation must be observed. Trademarks All names identified by are registered trademarks of Siemens AG. The remaining trademarks in this publication may be trademarks whose use by third parties for their own purposes could violate the rights of the owner. Disclaimer of Liability We have reviewed the contents of this publication to ensure consistency with the hardware and software described. Since variance cannot be precluded entirely, we cannot guarantee full consistency. However, the information in this publication is reviewed regularly and any necessary corrections are included in subsequent editions. Siemens AG Industry Sector Postfach NÜRNBERG GERMANY P 12/2011 Technical data subject to change Copyright Siemens AG All rights reserved

5 Table of contents 1 General CE Conformity Process in 9 Phases Phase 1: Determination of Applicable Directives Phase 2: Determination of the Conformity Evaluation Procedure Phase 3: Determination of Applicable Harmonized Standards Phase 4: Assurance of Compliance with Requirements Management Requirements Risk Assessment Phase 5: Preparation of Technical Documents Phase 6: Preparation of Declaration of Conformity or Declaration of Incorporation Phase 7: Attachment of CE Marking Phase 8: Quality Assurance Phase 9: Product Surveillance, Surveillance of Regulations and Standards Conformity Evaluation Relevant Standards Notes on Risk Assessment Implementation Step 1: Determination of the Limits of the Machine Step 2: Hazard Identification Mechanical Hazards Generated by Moved Parts / Equipment or Surfaces Mechanical Hazards During Normal Operation Electrical Hazards Thermal Hazards Noise Hazards Vibration Hazards Radiation Hazards Material / Substance Hazards Ergonomic Hazards - Hazards Generated by the Work Environment Step 3: Risk Estimation Step 4: Risk Evaluation Risk Matrix (Explanations) Risk Matrix Step 5: Risk Reduction Step 6: Realization of Safety Functions Software Requirements Notes on Verification...66 Reference Manual, 09/2011 3

6 Table of contents 4 Reevaluation of Realized Safety-Related Control Systems From EN to Functional Safety EN ISO EN Previous Application of EN Steps for Reevaluation Prerequisites for Reevaluation Determination of the Standard for the Safety Function's Evaluation Procedure in Accordance with EN ISO Procedure in Accordance with EN Further Information Basic Contents of Technical Documents Safety Layout Plan General Protective Measures Personal Protective Equipment (PPE) Safety Distances in Accordance with EN ISO General Safety Notes Warning Devices and Safety Labels Electrical Equipment (IEC ) Protection Against Electric Shock Protection in Case of Voltage Failures Overcurrent Protection Overload Protection of Motors Control Functions in Case of Failure EMERGENCY-OFF and EMERGENCY-STOP Devices Color Codes Typical Layout of a Safety Function Software Requirements Terms and Definitions EN ISO 12100:2010 or EN ISO EN EN ISO Important Type-A and Type-B Standards Internet Links CE Marking EC Directives Richtlinie 2006/42/EG (Maschinenrichtlinie) Important Addresses Document History Reference Manual, 09/2011

7 General 1 This guideline was prepared conjointly by TÜV Rheinland and Siemens AG. Copyright All contents, graphics, tables and figures of the reference manual "Standard-Compliant Risk Assessment Implementation in Accordance with EN ISO and EN ISO 12100:2010" are protected by copyright. Any copying of the reference manual "Standard-Compliant Risk Assessment Implementation in Accordance with EN ISO and EN ISO 12100:2010" or parts thereof shall only be permissible within the limits of statutory copyright regulations. Any transfer of the reference manual "Standard-Compliant Risk Assessment Implementation in Accordance with EN ISO and EN ISO 12100:2010" and/or its commercial utilization or disclosure of contents to third parties shall not be permitted. We reserve the right to take legal action in case of non-compliance, particularly with regard to claims for damages. Introduction Due to the principle of strict liability, a claimant merely has to prove the correlation between fault and damage to the manufacturer. This means that the manufacturer cannot exonerate himself by having taken "all measures in his power" in order to place a fault-free machine on the market but instead has to prove that the current state of science and technology was applied at the time of the machine's placing on the market. Even though the application of harmonized standards supports this approach as compliance with such standards helps to avoid liability-relevant safety deficits (presumption of conformity), such compliance does not constitute any ground for exemption from liability. The best approach for the avoidance of liability claims therefore lies in the improvement of product safety itself. A manufacturer who pursues an elaborate safety strategy and applies it in a practical manner will be extensively able to avoid liability claims. The consistent implementation of a CE conformity process and the establishment of a standard-compliant documentation process within the company in accordance with the requirements of applicable directives and standards represent central parts of such strategy. As a result, any illegally attached CE marking as well as far-reaching consequences resulting from non-conformity can be avoided. Ultimately, it is solely up to the manufacturer to live up to his responsibility and to initiate suitable measures. Reference Manual, 09/2011 5

8 General 6 Reference Manual, 09/2011

9 CE Conformity Process in 9 Phases 2 The CE conformity process in accordance with the German Equipment and Product Safety Act (ProdSG) or in accordance with the Machinery Directive can be divided into several phases and describes the individual measures which have to be taken prior to CE marking. The procedure described below offers support with the implementation of the CE conformity process. Phase 1: Determination of applicable directives Phase 2: Determination of the conformity evaluation procedure Phase 3: Determination of applicable harmonized standards Phase 4: Assurance of compliance with requirements Phase 5: Preparation of technical documents Phase 6: Preparation of declaration of conformity or declaration of incorporation Phase 7: Attachment of CE marking Phase 8: Quality assurance Phase 9: Product surveillance, surveillance of regulations and standards The CE conformity process covers the entire product lifecycle (PLC) as defined in the Machinery Directive (MD). The correlation between product lifecycle and CE conformity process is illustrated in the figure below. Reference Manual, 09/2011 7

10 CE Conformity Process in 9 Phases Phase 1: Phase 2: Phase 3: Phase 4 Phase 5 Phase 6 Phase 7 Phase 8: Phase 9 Figure 2-1 Product lifecycle and activities pertaining to CE marking However, the aspects of planning, design, construction and commissioning represent the focal points for risk assessment implementation. Faults occurring in these phases may entail particularly extensive consequences in terms of safety and machine costs. The phases themselves are divided into individual steps of varying complexity and duration and may affect several periods within the product lifecycle. 8 Reference Manual, 09/2011

11 CE Conformity Process in 9 Phases 2.1 Phase 1: Determination of Applicable Directives 2.1 Phase 1: Determination of Applicable Directives Machinery has to comply with the requirements of the applicable EU directives and has to be labeled with the CE marking. Therefore, also the requirements of several directives have to be met in dependence of the machinery's design, application and complexity. As shown in the figure below, the requirements equally address the manufacturer and the operator of a machine or system. This guideline describes the requirements placed upon the manufacturer. New approach Industrial safety directives National laws National laws Figure 2-2 Regulations and standards in Europe Note The requirements placed upon the operator, which are defined in the German Ordinance on Industrial Safety and Health, have to be met by the operator in addition to and independently of the procedure described in this guideline. They do not form part of risk assessment. The table below shows an excerpt of EU directives which request CE marking and may be applicable to machinery. Reference Manual, 09/2011 9

12 CE Conformity Process in 9 Phases 2.1 Phase 1: Determination of Applicable Directives Table 2-1 Relevant directives and their national implementation Directive No. of directive National implementation Machinery Directive 2006/42/EC (A) MSV 2010 (CH) MaschV (D) ProdSG Application scope a) Machinery b) Replaceable equipment c) Safety components d) Load-carrying equipment e) Chains, ropes and belts f) Removable articulated shafts g) Partly completed machinery h) Machinery mounted on vehicles Exceptions a) Safety components supplied as original spare parts b) Equipment for application in fairgrounds and amusement parks c) Machinery designed or employed for nuclear applications d) Weapons and firearms e) Means of transport Agricultural and forestry tractors Motor vehicles and trailers Means of transport for transport by air, on water and on rail networks... f) Seagoing vessels and mobile offshore units g) Machinery for military purposes or for maintenance of the public order h) Machinery for research purposes and for temporary use in laboratories i) Mine winding gear j) Machinery intended to move performers during artistic performances k) Household appliances, audio and video equipment, information technology equipment, ordinary office machinery, low-voltage switchgear and controlgear, electric motors l) Switchgear and controlgear, transformers 10 Reference Manual, 09/2011

13 CE Conformity Process in 9 Phases 2.1 Phase 1: Determination of Applicable Directives Directive No. of directive National implementation Electromagnetic Compatibility 2004/108/EC (A) EMV-V (CH) VEMV (D) EMV-Gesetz Application scope Electrical and electronic appliances, equipment and systems which contain electrical or electronic components or which may cause electromagnetic interference or whose operation may be impaired by such interference Exceptions Radio equipment and telecommunications terminal equipment Aeronautical products Motor vehicles Radio equipment used by radio amateurs Directive No. of directive National implementation Low-Voltage Directive 2006/95/EC (A)NSpGV (CH) NEV, EleG, STEG (D) ProdSG Application scope Electrical equipment designed for use with a voltage rating between 50 and V for alternating current and between 75 and V for direct current Exceptions Electrical equipment for use in explosive atmospheres, electrical radiology equipment Electrical medical equipment, electric parts of passenger and goods lifts, electricity meters, household plugs and sockets, devices for the power supply of electric fence controllers, radio interference suppression devices Special electrical equipment intended for application in aircrafts, on ships or in railways Reference Manual, 09/

14 CE Conformity Process in 9 Phases 2.1 Phase 1: Determination of Applicable Directives Directive No. of directive National implementation Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres 94/9/EC (A)BGBL. Nr. 252/1996; ExSV 1996 (CH) VGSEB (D) ProdSG Application scope Equipment and protective systems intended for use in potentially explosive atmospheres Exceptions Medical devices for intended use in medical applications Equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances Equipment intended for use in domestic and non-commercial environments Personal protective equipment Seagoing vessels and mobile offshore units together with equipment on board such vessels or units Means of transport, i.e. vehicles and their trailers intended solely for transporting passengers and goods Directive No. of directive National implementation Pressure Equipment 97/23/EC (A) BGBI.II Nr. 420 (CH) SR (D) ProdSG Application scope Vessels (unfired pressure vessels) Steam generators Piping Pressure-retaining equipment parts and equipment parts with safety function with an internal gauge pressure greater than 0.5 bar Exceptions Pneumatic tires, air cushions, balls used for play, inflatable craft, bottles or cans for carbonated drinks Radiators and pipes in warm water heating systems Directive No. of directive National implementation Simple Pressure Vessels 87/404/EEC (A)BGBI. 388/94 (CH)SR (D)ProdSG Application scope Welded vessels subjected to an internal pressure greater than 0.5 bar which are intended to contain air or nitrogen and which are not intended to be fired Exceptions Vessels designed for nuclear use Vessels for installation in or the propulsion of ships and aircraft Fire extinguishers 12 Reference Manual, 09/2011

15 CE Conformity Process in 9 Phases 2.1 Phase 1: Determination of Applicable Directives Directive No. of directive National implementation Outdoor 2000/14/EC (A)BGBl. 249/2001 (CH)Maschinenlärmverordnung MaLV (D) Bundesimmissionsschutzgesetz (BImSchG) Application scope Equipment and machinery intended for outdoor use Exceptions Non-powered attachments; equipment for the transport of goods or persons; equipment for military or police purposes or for emergency services Directive No. of directive National implementation Ecodesign of Energy-Using Products 2005/32/EC (A)Ökodesign-Verordnung 2007 (CH)Energieverordnung (EnV, SR ) (D)Energiebetriebene-Produkte- Gesetz (EBPG) Application scope All products such as von den boilers, water heaters, PCs, computer monitors, certain refrigerators and freezers, dishwashers, washing machines and dryers, transformers covered by the implementing measures Exceptions All products not covered by the implementing measures Table 2-2 Check list for phase 1 No. Task Evaluation 1 How is the product defined? (type of product, intended use, application area, ) 2 Which EU directive(s) is the product subject to? (application verification; if multiple directives are applicable, all applicable directives must be observed!) Directive Machinery Directive Electromagnetic Compatibility Low-Voltage Directive Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Pressure Equipment Simple Pressure Vessels Outdoor Ecodesign of Energy-Using Products 3 Which basic requirements can be derived from the directive(s)? No. of directive 2006/42/EC 2004/108/EC 2006/95/EC 94/9/EC 97/23/EC 87/404/EEC 2000/14/EC 2005/32/EC Applicable Yes No Reference Manual, 09/

16 CE Conformity Process in 9 Phases 2.2 Phase 2: Determination of the Conformity Evaluation Procedure 2.2 Phase 2: Determination of the Conformity Evaluation Procedure Every directive and the respective national regulations based thereon describe the scope and contents of possible conformity evaluation procedures which are assumed to offer the required protection level. The directives also specify the criteria for conditions from which the manufacturer may chose one of several available options. Furthermore, the respective directives describe the factors which were considered for determining the scope of possible procedures. The procedures (modules) to be applied therefore vary from product to product. The figure below shows the possible procedure for machine types defined in the Machinery Directive. Figure 2-3 CE conformity evaluation procedure in accordance with the Machinery Directive Note It has to be generally specified whether the module of internal production control or that of EC type examination is applied to machinery. Table 2-3 Check list for phase 2 No. Task Evaluation 1 Does the product's conformity with the requirements specified in the EU directive has to be compulsorily confirmed by a notified body in the form of a certificate? 2 Is a notified body to be voluntarily consulted in cases of doubt? 14 Reference Manual, 09/2011

17 CE Conformity Process in 9 Phases 2.3 Phase 3: Determination of Applicable Harmonized Standards 2.3 Phase 3: Determination of Applicable Harmonized Standards Directives only define the safety and health protection targets without providing any specific notes as to how to attain these targets. Applicable standards and particularly the harmonized European standards can be used to specify the essential requirements more precisely. With these standards, so-called presumption of conformity is assumed, i.e. application of these standards to the product design causes authorities to presume conformity with the directive's requirements. As the application of standards is not required by law, the protection target of the EU directives can also be attained in a different way. However, it should to be taken into account that the harmonized standards reflect state-of-the-art technology and that proving compliance with the directives without their application is difficult in case of damage. In other words: The easiest way to ensure conformity with the EC directives lies in compliance with the European standards harmonized on their basis. They thus adopt a quasi-legal character. Note The European designation (e.g. EN ISO , EN 62061) is used for all standards quoted in the following. This designation hence also refers to the respective country-specific standard (e.g. DIN EN ISO , DIN EN or EN ISO 12100:2010). Classification of European standards Depending on their application scope, the European harmonized standards are classified as follows: Type-A standards: Basic safety standards Type-B standards: Generic safety standards Type-C standards: Product group-specific machine safety standards The table below shows examples of typical harmonized standards. It includes: Type-A standards (basic safety standards), dealing with basic concepts, principles for design and general aspects applicable to all machines, equipment and systems (example: EN 12100) Type-B standards (generic safety standards), dealing with a single safety aspect or a single type of safeguard which can be used for a wide range of machines, equipment and systems. Type-B standards are sub-divided into B1 and B2 standards. Type-B1 standards refer to special safety aspects (e.g. safety distances, surface temperatures, noise) Type-B2 standards refer to special safeguards (e.g. two-hand control devices, interlocking devices, pressure-sensitive mats, guards) Type-C standards (machine safety standards), dealing with detailed safety requirements for a particular machine or group of machines Reference Manual, 09/

18 CE Conformity Process in 9 Phases 2.3 Phase 3: Determination of Applicable Harmonized Standards Note The manufacturer is responsible for determining the applicable standards for design. If a machine safety standard (C standard) exists for a machine, this standard has to be used as the basis for risk assessment implementation and design. If no machine safety standard exists, applicable basic safety standards and generic safety standards (A and B standards) have to be used. Table 2-4 Examples of typical harmonized standards Standard type No. of standard Title of standard Type-A standard Basic safety standards Type-B1 standard Generic safety standards for specific safety aspects Type-B2 standard Generic safety standards for safeguards Type-C standard Basic safety standards EN ISO or EN ISO 12100:2010 EN 349 EN EN ISO EN EN ISO (EN 13857, EN 811) EN (EN 999) EN ISO EN EN 574 EN 1088 EN 953 EN 982 EN 692 EN 693 EN EN EN EN 201 EN Safety of machinery Risk assessment Part 1: Principles Minimum gaps to parts of the human body Safety distances to lower limbs Electrical equipment of machines Safety-related parts of control systems Part 1: General principles for design Functional safety of safety-related electrical, electronic and programmable electronic control systems Safety distances to prevent hazard zones being reached by upper and lower limbs Positioning of safeguards with respect to the approach speeds of parts of the human body Emergency-stop devices ESPE Two-hand control devices Interlocking devices Guards Hydraulics Mechanical presses Hydraulic presses Industrial robots Small numerically controlled turning machines Large numerically controlled turning machines Injection molding machines Laser processing machines Note However, many of the required standards are still in a draft or pre-standard state. This particularly applies to the machine safety standards. It is therefore essential for machine manufacturers to introduce reliable procedures for standards surveillance (phase 9) in the quality assurance system. 16 Reference Manual, 09/2011

19 CE Conformity Process in 9 Phases 2.3 Phase 3: Determination of Applicable Harmonized Standards The harmonized standards to be used for design in order to attain presumption of conformity can be determined on the basis of standards research. These standards or individual sections thereof can be referenced in the risk assessment to allow for a more precise specification of the design / development requirements. Table 2-5 Check list for phase 3 No. Task Evaluation 1 Do applicable harmonized European standards exist? 2 Do national standards or other specifications exist which may be helpful in addition to the "harmonized" ones? 3 Do standard requirement specifications exist for the product? 4 Do standard requirement specifications or quality assurance agreements for suppliers exist? Reference Manual, 09/

20 CE Conformity Process in 9 Phases 2.4 Phase 4: Assurance of Compliance with Requirements 2.4 Phase 4: Assurance of Compliance with Requirements To assure compliance with the requirements, all disciplines involved in the machine's construction / production (e.g. mechanical / electrical design, software, QM, documentation, hydraulics/ pneumatics,...) have to reliably and jointly carry out their tasks within the scope of the CE conformity process in accordance with the figure "Regulations and standards in Europe" in chapter "Phase 1: Determination of Applicable Directives (Page 9)" Management Requirements The internal procedures, plans and tests to be implemented for hardware and software required for compliance with the machine's requirements have to be specified within the organization. The manufacturer has to specify and document competence, responsibility and authorization with regard to CE conformity within the company. Amongst others, this comprises: Organization Determination of involved disciplines Determination of responsibility and authorization Definition of interfaces Documentation, in particular: Preparation, verification, release, distribution and archiving of technical documents Change management (modification procedures) Software (change and configuration management) 18 Reference Manual, 09/2011

21 CE Conformity Process in 9 Phases 2.4 Phase 4: Assurance of Compliance with Requirements Risk Assessment The machine manufacturer is obliged to implement risk assessment in order to identify all hazards associated with his system, to assess and evaluate the respective risks and to design and construct the system in consideration of such hazards. Risk assessment implementation is to be considered a design-accompanying process which is to be carried out by experts of various disciplines. Risk assessment requires teamwork and necessitates the consideration of numerous aspects. In this context, the EN ISO 12100:2010 standard offers support as it describes an iterative procedure for risk assessment. The procedure was adopted in accordance with EN ISO in the order shown in the figure below. START Determination of the machine's limits EN ISO , clause 5.2 Hazard Identification EN ISO , clause 4 and 5.3 Risk analysis Risk estimation EN ISO , clause 5.3 Risk evaluation EN ISO , clause 5.3 Risk assessment Has the risk been adequately reduced? YES END NO Risk reduction (ISO and -2) Figure 2-4 Risk assessment in accordance with EN ISO and EN ISO 12100:2010 Reference Manual, 09/

22 CE Conformity Process in 9 Phases 2.4 Phase 4: Assurance of Compliance with Requirements The individual steps of the procedure are described in chapter 3. Also the involvement of independent experts with profound knowledge of standards and long-standing sector experience should be considered as such experts are able to analyze safety aspects from a different point of view and can thus provide manufactures with additional insight. Note The risk assessment may already form part of machine-specific standards (type-c standard). However, the application of a type-c standard does not exempt the manufacturer from his obligation to implement his own risk assessment. This is intended to prevent the overlooking of risks which accrue as a result of the application of new technologies and procedures. 20 Reference Manual, 09/2011

23 CE Conformity Process in 9 Phases 2.5 Phase 5: Preparation of Technical Documents 2.5 Phase 5: Preparation of Technical Documents The Machinery Directive requests the preparation of verification documentation. The documents to be prepared are listed below in an exemplary manner. The type and number of documents may vary from machine to machine. Project documentation Requirement specifications (HW and SW specifications) Safety plan Verification plan Validation plan Development documentation Functional specifications Test plans (HW and SW) Design documents (mechanics, electrical engineering, fluidics,...) Circuit diagrams, parts lists Calculations Test reports.. Handbooks Transport handbook Commissioning handbook Instruction handbook (organizational measures / residual risks) Maintenance handbook (service) Dismantling handbook Safety layout plans (e.g. warnings, safety-relevant components, ) Safety data sheets Reference Manual, 09/

24 CE Conformity Process in 9 Phases 2.6 Phase 6: Preparation of Declaration of Conformity or Declaration of Incorporation 2.6 Phase 6: Preparation of Declaration of Conformity or Declaration of Incorporation Basic contents of the CE declaration of conformity for machines Company designation, complete address of the manufacturer and his authorized representative Name and address of the person authorized to compile the technical documents General designation of the machine, function, model, type, serial number and trade name Declaration of conformity with the 2006/42/EC Machinery Directive With EC type examination: Name, address and identification number of the notified body With quality assurance system in accordance with Annex X: Name, address and identification number of the notified body Location and date of the declaration Information on the representative authorized for the declaration's preparation as well as signature of this person Basic contents of the declaration of incorporation for partly completed machinery Company designation, complete address of the manufacturer and his authorized representative Name and address of the person authorized to compile the relevant technical documents General designation of the function, model, type, serial number and trade name Declaration as to which basic requirements of the directive are applied and complied with Declaration that the technical documents were prepared in accordance with Annex VII Part B or that the partly completed machinery complies with other applicable directives Obligation to provide the specific documents on the partly completed machine to national bodies upon a reasoned request Note stating that the partly completed machinery must not be commissioned before the machinery into which it is to be incorporated complies with the requirements of this directive Location and date of the declaration Information on the representative authorized for the declaration's preparation as well as signature of this person Note The manufacturer or authorized representative of a machinery or partly completed machinery is obliged to keep the original EC declaration of conformity or declaration of incorporation for a period of at least 10 years after the last date of production of the machinery or the partly completed machinery. 22 Reference Manual, 09/2011

25 CE Conformity Process in 9 Phases 2.7 Phase 7: Attachment of CE Marking 2.7 Phase 7: Attachment of CE Marking The CE marking is attached to the product or its rating plate in a soundly visible, readable and permanent manner. If this is not permitted or justified by the nature of the product, the marking is attached to the packing and the accompanying documents, given the respective legal regulation requests such documents. The CE marking is attached to the product before it is put into circulation. Depending on the requirements of the EU directives, the CE marking has to be attached with or without the identification number of the appointed body. The CE marking consists of the letters "CE" in the type face shown in the figure below. When decreasing or increasing the size of the CE marking, the proportions of the represented grid must be maintained. If no detailed dimensions are specified in the applicable legal requirements, a minimum height of 5 mm has to be observed for the CE marking. According to the German Equipment and Product Safety Act, the CE marking must not be used for products for which such CE marking is not required under the EU directives. Figure 2-5 CE marking Reference Manual, 09/

26 CE Conformity Process in 9 Phases 2.8 Phase 8: Quality Assurance 2.8 Phase 8: Quality Assurance Monitoring of the production process by the manufacturer on the basis of a suitable QM system, with externally tested products (machines) mostly with a demonstration model in accordance with EN ISO 9001 or a special standard, surveyed by an appointed body. 2.9 Phase 9: Product Surveillance, Surveillance of Regulations and Standards Observance of changes in the essential requirements and harmonized standards; if applicable, re-examination and renewed testing / certification in case of basic changes of the product adapted to state-of-the-art technology. The latter also applies to product or production changes implemented by the manufacturer without any changes in the essential requirements or harmonized standards. Regular tracking of product problems in the RAPEX system and, where required, adaptation of the product. RAPEX (RApid EXchange of information on dangers arising from the use of consumer products) represents the rapid warning system of the EU for all hazardous consumer goods, with the exception of foodstuffs, pharmaceuticals and medical equipment. Every Friday, the Commission publishes a weekly overview of hazardous products of which it was notified by the national authorities (RAPEX notifications). This weekly overview includes a summary of all information on the product, the hazards posed by it and the measures taken by the respective country. Note With series production, phases 8 (quality assurance) and 9 (product surveillance) have to be particularly observed for the series products' ongoing CE marking. 24 Reference Manual, 09/2011

27 CE Conformity Process in 9 Phases 2.10 Conformity Evaluation 2.10 Conformity Evaluation Table 2-6 Tasks and results of conformity evaluation Tasks and results Is the list of applicable basic safety and health requirements in accordance with the 2006/42/EC Machinery Directive available? Is a list of the applied standards and other technical specifications available? Was the presently current state of the standard applied to the conformity evaluation process? (see EU Gazette) Is a list of the basic safety and health requirements in accordance with the 2006/42/EC Machinery Directive dealt with by the standards available? Were hidden hazards also included in the risk analysis, i.e. hazards which can generally only be detected through application of the standards? Examples based on electrical control systems: Evaluation Protection against faulty operation caused by ground faults Start functions have to be initiated through excitation of the corresponding circuit Protection against unintended start-up Examples based on safeguards: Sufficiently stable construction Exclusion of additional hazard causation Sufficient distance to the hazard zone Were the hazards on the basis of Annex A of EN ISO or EN ISO 12100:2010 determined? Annex A does not guarantee completeness and is therefore purely informative. Do the hazards covered by the risk analysis meet all applicable requirements of Annex I of the 2006/42/EC Machinery Directive? (assignment of hazards to the requirements of Annex I of the 2006/42/EC Machinery Directive required) Were the tests specified in the harmonized standards implemented and documented? Is an instruction handbook available which covers the intended use, reasonably foreseeable misuse, all lifecycles and the residual risks? Is an assembly handbook available for machines intended to be incorporated in other machines, referred to as partly completed machinery by the 2006/42/EC Machinery Directive? Is the EC declaration of conformity complete, including conformity statement (indication of the EC directive)? Is an incorporation handbook available for machines intended to be incorporated in other machines? Possible evaluation: Yes (Y) No (N) Not verifiable (N v) Not applicable (N a) Not complete (N c) Reference Manual, 09/

28 CE Conformity Process in 9 Phases 2.11 Relevant Standards 2.11 Relevant Standards Research of standards Yet, the measures to be complied with for guaranteeing the safety of products are generally not specified by the directives alone. In addition to the mostly very generally formulated requirements of the directives, standards exist. The safety measures specified in the standards are more precise and are partially directly adapted to various machine types for instance. Due to the harmonization of standards, the requirements specified in the standards are not only nationally applicable, but throughout Europe. Harmonized standards represent standards which have been approved by a European standards organization. These standards carry the abbreviation "EN" in their title. Subject to the complete application of harmonized standards, the manufacturer may presume conformity with the basic requirements of the directive. This is referred to as "presumption of conformity". Various tools and websites may be used for researching the respectively relevant standards: Beuth publishing house ( KAN (German Commission for Occupational Health and Safety and Standardization) ( NoRA (Occupational Health & Safety Standards Search Tool by KAN) ( Globalnorm (Standards Database) ( FIZ Technik (Technical Information Database) ( VDMA Database (German Engineering Federation) ( The table below lists all hazards as well as the respective requirements in accordance with Annex I of the Machinery Directive (MD) as well as EN ISO Furthermore, standards which may be additionally applied for risk reduction are indicated. The indications may be explicitly referenced in the risk assessment. Risk assessment EN ISO :2007 and EN ISO 12100:2010 Safety of Machinery Risk Assessment Part 1: Principles (EN ISO :2007 and EN ISO 12100:2010) Note Alternative or supplementary methods are contained in IEC Hazard and operability studies (HAZOP) Guideline EN Analysis techniques for system reliability Failure mode effects analysis (FMEA) 26 Reference Manual, 09/2011

29 CE Conformity Process in 9 Phases 2.11 Relevant Standards Table 2-7 Hazards and corresponding requirements in accordance with the Machinery Directive Hazards Annex I MD EN EN Other directives and standards 1 Mechanical hazards 1.1 Crushing , 5 EN ISO 13857:2008 Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs (EN ISO 13857:2008) Insufficient minimum gap EN 349:1993+A1:2008 Safety of machinery Minimum gaps to avoid crushing of parts of the human body Mass and/or velocity of parts Insufficient mechanical strength 1.2 Actuating force Shearing , 5 Insufficient minimum gap EN 349:1993+A1:2008 Safety of machinery Minimum gaps to avoid crushing of parts of the human body Form of shearing elements Mass and/or velocity of parts Insufficient mechanical strength 1.3 Actuating force Cutting / severing , 5 EN ISO 13857:2008 Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs (EN ISO 13857:2008) Insufficient minimum gap EN 349:1993+A1:2008 Safety of machinery Minimum gaps to avoid crushing of parts of the human body Form of cutting elements: EN ISO 13857:2008 Safety of machinery Safety distances to prevent Sharp edges hazard zones being reached by upper Rough surfaces and lower limbs Mass and/or velocity of parts Insufficient mechanical strength Actuating force 1.4 Entanglement , 5 Movement of parts Form and relative position of parts Mass and/or velocity of parts Propulsive force 1.5 Drawing-in or trapping , Impact , Stabbing / puncture , 5 Reference Manual, 09/

30 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards Annex I MD Friction / abrasion of materials b General properties Corrosion, ageing, abrasion and wear Homogeneity Toxicity High pressure fluid injection or ejection Exceedance of the maximum permissible pressure Pressure loss Pressure drop Vacuum loss Leakage Component failure Vessels and reservoirs do not comply with the design specifications for such components Inadequate fastening of lines System parts, especially pipes and hoses, are not protected against harmful external effects Reservoirs and vessels are not automatically de-pressurized when the machine is isolated from the power supply EN EN Other directives and standards Safety data sheet , 5 Directive 97/23/EC Pressure equipment EN Unfired pressure vessels Part 5: Inspection and testing EN Unfired pressure vessels Part 6: Requirements for the design and fabrication of pressure vessels and pressure parts constructed from spheroidal graphite cast iron Directive 87/404/EEC Simple pressure vessels ZH 1/74 28 Reference Manual, 09/2011

31 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards Annex I MD Ejection of parts 1.3.2, EN EN Other directives and standards , 5 Mass and velocity EN 13855: 2010 Safety of machinery Positioning of safeguards with respect to the approach speeds of parts of the human body (substitutes EN 999:1998+A1:2008) Acceleration Insufficient mechanical strength Exceedance of the maximum permissible pressure Pressure drop / vacuum loss Areas which remain pressurized when the machine is isolated from the power supply Loss of stability of the machine or machine parts Non-observance of rules regarding: Design and construction of machinery (calculation rules) External forces, e.g. vibration, wind pressure, impact, climate Internal forces, e.g. gravity Dynamic forces, e.g. vibration, electrodynamic forces Insufficient mechanical strength Non-observance of instruction handbook Unsuitable foundation (e.g. subsidence on one side) with consequences such as collapsing, falling, crushing or crumpling Slipping / stumbling / falling due to mechanical properties Slippery materials in walkways Unsuitable banisters, posts, baseboards and handrails Insecure means of access (stairs, ladders, etc.) to all relevant positions: Adjustment, operation, maintenance a, 4.6, b, 4.8, EN 982:1996+A1:2008 Safety of machinery Safety requirements for fluid power systems and their components Hydraulics EN 983:1996+A1:2008 Safety of machinery Safety requirements for fluid power systems and their components Pneumatics Reference Manual, 09/

32 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards 2 Electrical hazards Annex I MD 2.1 Direct contact with live parts 1.5.1, Direct or indirect contact with parts which have become live under fault conditions 2.3 Approach to live parts under high voltage EN EN Other directives and standards , IEC (VDE 0175) IEC standard voltages EN Safety of machinery Electrical equipment of machines Part 1: General requirements EN IEC 61439: New standard for lowvoltage switchgear and controlgear assemblies EN Safety of machinery Electrical equipment of machines Part 1: General requirements EN Insulation coordination for equipment within low-voltage systems Principles requirements and tests 1.5.1, , Electrostatic phenomena EN Electrostatics Part 2-1: Measurement methods Ability of materials and products to dissipate static electric charge EN Electrostatics Part 2-3: Methods of test for determining the resistance and resistivity of solid planar materials used to avoid electrostatic charge accumulation EN Electrostatics Part 3-1: Methods for simulation of electrostatic effects: Human body model (HBM) Component testing EN Electrostatics Part 3-2: Methods for simulation of electrostatic effects: Machine model (MM) Component testing 30 Reference Manual, 09/2011

33 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards 3 Thermal hazards 3.1 Burns, scalds, frost bites and other injuries caused by contact with objects or materials at very high or low temperature, by flames or explosions as well as by the radiation of heat sources 3.2 Health damage due to hot/cold working environment Annex I MD 1.5.5, 1.5.6, EN EN Other directives and standards EN 563 Establishment of temperature limit values for hot surfaces EN Ergonomics of the thermal environment Temperatures of touchable hot surfaces Guidance for establishing surface temperature limit values EN ISO :2008 Ergonomics of the thermal environment Methods for the assessment of human responses to contact with surfaces Part 1: Hot surfaces EN ISO :2008 Ergonomics of the thermal environment Methods for the assessment of human responses to contact with surfaces Part 3: Cold surfaces 4 Noise hazards EN ISO 3741:2009 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Precision methods for reverberation rooms EN ISO :2009 Acoustics Determination of sound power levels and sound energy levels of noise sources Engineering methods for small, movable sources in reverberant fields Part 1: Comparison method for hard-walled test rooms EN ISO :2009 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for small, movable sources in reverberant fields Part 2: Methods for special reverberation test rooms EN ISO 3744:2009 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering method in an essentially free field over a reflecting plane Reference Manual, 09/

34 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards Annex I MD EN EN Other directives and standards EN ISO 3745:2009 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Precision methods for anechoic and hemi-anechoic rooms EN ISO 3746:2009 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane EN ISO 3747:2009 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Comparison method in situ EN ISO 4871:2009 Acoustics Declaration and verification of noise emission values of machinery and equipment EN ISO :2009 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound intensity Part 1: Measurement at discrete point EN ISO :2009 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound intensity Part 3: Precision method for measurement by scanning EN ISO 11200:2009 Acoustics Noise emitted by machinery and equipment Guidelines for the use of basic standards for the determination of emission sound pressure levels at a work station and at other specified positions EN ISO 11201:2010 Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections 32 Reference Manual, 09/2011

35 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards 4.1 Hearing impairment, hearing loss (deafness) or other physiological impairment (e.g. disturbance of equilibrium, diminished advertency) 4.2 Interference with speech communication, interference with auditory signals, etc. 5 Vibration hazards 5.1 Use of hand-guided tools over a prolonged period with the result of nerve and vascular disorders 5.2 Whole-body vibration, especially in connection with forced postures Annex I MD EN EN Other directives and standards , EN ISO 11202: 2010 Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections EN ISO 11203:2009 Acoustics Noise emitted by machinery and equipment Determination of emission sound pressure levels at a work station and at other specified positions from the sound power level EN ISO 11204:2009 Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at a work station and at other specified positions Method requiring environmental corrections EN ISO 11205:2009 Acoustics Noise emitted by machinery and equipment Engineering method for the determination of emission sound pressure levels in situ at the work station and at other specified positions using sound intensity EN :2008 Safety of machinery Indication, marking and actuation Part 1: Requirements for visual, acoustic and tactile signals EN ISO 7731:2008 Ergonomics Danger signals for public and work areas Auditory danger signals (ISO 7731:2003) EN 1299:1997+A1:2008 Mechanical vibration and shock Vibration isolation of machines Information for the application of source isolation Reference Manual, 09/

36 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards Annex I MD EN EN Other directives and standards 6 Radiation hazards EN :2000+A1:2008 Safety of machinery Assessment and reduction of risks arising from radiation emitted by machinery Part 1: General principles EN :2002+A1:2008 Safety of machinery Assessment and reduction of risks arising from radiation emitted by machinery Part 2: Radiation emission measurement procedure EN :2002+A1:2008 Safety of machinery Assessment and reduction of risks arising from radiation emitted by machinery Part 3: Reduction of radiation by attenuation or screening 6.1 Radiation with low frequency, radio frequency, microwaves 6.2 Infrared, visible and ultraviolet light 6.3 X-rays and gamma rays 6.4 Alpha rays, beta rays, electron or ion beams, neutron beams , , Laser beams EN ISO 11145:2008 Optics and photonics Lasers and laser-related equipment Vocabulary and symbols EN ISO 11252:2008 Lasers and laserrelated equipment Laser device Minimum requirements for documentation (ISO 11252:2004) EN ISO 11554:2008 Optics and photonics Lasers and laser-related equipment Test methods for laser beam power, energy and temporal characteristics EN 12254:1998+A2:2008 Screens for laser working places Safety requirements and testing EN Safety of laser products Part 1: Equipment classification and requirements 34 Reference Manual, 09/2011

37 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards 7 Hazards generated by materials and substances (and their components) which are processed and used by the machine 7.1 Due to contact with or inhalation of hazardous liquid, gas, mist, vapor and dust 7.2 Hazards generated by overheating, fire or explosion 7.3 Biological or microbiological hazards (caused by viruses or bacteria) Annex I MD 1.1.3, , EN EN Other directives and standards EN 626-1:1994+A1:2008 Safety of machinery Reduction of risks to health from hazardous substances emitted by machinery Part 1: Principles and specifications for machinery manufacturers EN 626-2:1996+A1:2008 Safety of machinery Reduction of risk to health from hazardous substances emitted by machinery Part 2: Methodology leading to verification procedures 4.8 EN :2008 Safety of machinery Evaluation of the emission of airborne hazardous substances Part 1: Selection of test methods 4.8 Directives ATEX 100a and ATEX 137 New regulations for equipment and protective systems in potentially explosive atmospheres EN :2007 Explosive atmospheres Explosion prevention and protection Part 1: Basic concepts and methodology EN Electrical apparatus for explosive gas atmospheres Part 0: General requirements Reference Manual, 09/

38 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards 8 Hazards generated by neglecting ergonomic principles for the design of the machine Annex I MD EN EN Other directives and standards EN 614-1:2006+A1:2009 Safety of machinery Ergonomic design principles Part 1: Terminology and general principles EN 614-2:2000+A1:2008 Safety of machinery Ergonomic design principles Part 2: Interactions between the design of machinery and work tasks EN 547-1:1996+A1:2008 Safety of machinery Human body measurements Part 1: Principles for determining the dimensions required for openings for whole body access into machinery EN 547-2:1996+A1:2008 Safety of machinery Human body measurements Part 2: Principles for determining the dimensions required for access openings EN 547-3:1996+A1:2008 Safety of machinery Human body measurements Part 3: Anthropometric data EN 894-1:1997+A1:2008 Safety of machinery Ergonomics requirements for the design of displays and control actuators Part 1: General principles for human interactions with displays and control actuators EN 894-2:1997+A1:2008 Safety of machinery Ergonomics requirements for the design of displays and control actuators Part 2: Displays EN 894-3:2000+A1:2008 Safety of machinery Ergonomics requirements for the design of displays and control actuators Part 3: Control actuators EN :2001+A1:2008 Safety of machinery Human physical performance Part 1: Terms and definitions EN :2003+A1:2008 Safety of machinery Human physical performance Part 2: Manual handling of machinery and component parts of machinery 36 Reference Manual, 09/2011

39 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards Annex I MD 8.1 Bad posture or excessive effort 1.1.2d, 1.1.5, 1.6.2, Insufficient observance of the anatomy of hand/arm or foot/leg 8.3 Negligent use of personal protective equipment EN EN Other directives and standards , d, e 4.9 EN :2002+A1:2008 Safety of machinery Human physical performance Part 3: Recommended force limits for machinery operation EN :2005+A1:2008 Safety of machinery Human physical performance Part 4: Evaluation of working postures and movements in relation to machinery 8.4 Inappropriate local lighting EN 1837:1999 +A1:2009 Safety of machinery Integral lighting of machines 8.5 Mental overload or underload, stress 1.1.2d Human misbehavior, human behavior 1.1.2d, 1.2.2, 1.2.5, 1.2.8, 1.5.4, , , , Unsuitable design, location or identification of manual controls (actuators) 8.8 Unsuitable design or location of visual displays Combination of hazards 4.11 Reference Manual, 09/

40 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards 10 Hazards generated by unexpected start-up, unexpected overrunning / overrevving (or any comparable malfunction) Annex I MD 10.1 Failure / fault of the control system 1.2.7, Restoration of the power supply after an interruption 10.3 External influences on electrical equipment 10.4 Other harmful influences (gravity, wind, etc.) EN EN Other directives and standards EN 1037:1995+A1:2008 Safety of machinery Prevention of unexpected start-up EN ISO 13850:2008 Safety of machinery Emergency stop Principles for design (ISO 13850:2006) EN ISO :2008 Safety of machinery Safety-related parts of control systems Part 1: General principles for design EN ISO :2008/AC:2009 EN ISO :2008 Safety of machinery Safety-related parts of control systems Part 2: Validation , Software faults EN Software requirements 10.6 Maloperation (attributable to insufficient adaptation of the machinery to human characteristics and capabilities) Lacking possibility of stopping the 1.2.4, EN machine under optimum conditions 1.2.6, Variation in the rotational speed of , 4.3 tools 13 Power supply failure , Control circuit or control loop failure 1.2.1, 1.2.3, 1.2.4, 1.2.5, 1.2.7, , Faulty assembly , Breakage during operation Falling or ejected objects or liquids , 4.10, 5 18 Loss of stability / tilting of the machine , Slipping, stumbling or falling of persons (in correlation with machinery) b, 4.8, Reference Manual, 09/2011

41 CE Conformity Process in 9 Phases 2.11 Relevant Standards Hazards Annex I MD EN EN Other directives and standards 20 Technical documents VDI 4500 Technical Documentation Recommendations for the preparation and distribution of electronic spare parts information EN (2007) (VDE ) Preparation of documents used in electrotechnology Part 1: Rules EN (2002) GRAFCET, specification language for sequential function charts EN (2001) Structuring of technical information and documentation EN (2001) Preparation of parts lists 21 Instructions IEC International electrotechnical vocabulary (IEV) Parts 301, 302, 303: General terms on measurements in electricity Electrical measuring instruments Electronic measuring instruments EN Preparation of instructions Structuring, content and presentation 22 Warnings EN ISO Graphical symbols Safety colors and safety signs Design principles for safety signs in workplaces and public areas EN ISO Graphical symbols Safety colors and safety signs Design principles for product safety labels Reference Manual, 09/

42 CE Conformity Process in 9 Phases 2.11 Relevant Standards 40 Reference Manual, 09/2011

43 Notes on Risk Assessment Implementation Step 1: Determination of the Limits of the Machine In the first step, the limits of the machine are determined. Table 3-1 Limits of the machine Space limits Range of movement of the machine Interfaces Range of movement of persons Use limits Intended use In accordance with the dimensions specified in the drawings valid for this machine All power supply units for fluids and electrics directly attached to the machine down to the transfer point to their power supply line Space requirements for installation and maintenance Space requirements for operation In accordance with the technical specifications applicable to this machine within the scope of the manufacturer's responsibility, including: Operating modes Use phases Various intervention phases of personnel Reasonably foreseeable misuse Use not as intended Time limits Life limit Maintenance intervals Any use other than the intended use Estimated life limit of the machine and its components taking into account the intended use In accordance with the test and maintenance intervals specified for this machine Reference Manual, 09/

44 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification 3.2 Step 2: Hazard Identification Potential hazards generated by machinery, taking into account the essential requirements formulated in the Machinery Directive, are described in EN ISO and EN ISO 12100:2010. It is recommended to examine the machine on the basis of the hazards described therein and to document any identified hazards. Particularly the following aspects should be taken into account for hazard identification: Hazards in all lifecycles (life limit phases) and operating modes of the machine Interaction between machine and operating personnel, further machines and their power supply Possible malfunctioning of the machine Intended use of the machine and its components Physical properties of operating personnel and corresponding training level Table 3-2 Identification of operations and tasks throughout the lifecycles (on the basis of Table A.3 of EN ISO ) Lifecycles Operations / tasks / actions (in accordance with EN ISO and EN ISO 12100:2010) Transport Assembly / installation (at the machine's operation location) Commissioning Setting / teaching programming / process changeover Lifting Loading Packing Transportation Unloading Unpacking Adjustment of the machine Assembly Connection to the disposal system (e.g. exhaust air, waste water) Connection to the power supply (e.g. electricity, water, hydraulics) Demonstration Feeding, filling (e.g. lubricant, hydraulic oil) Fencing Fixing, anchoring Preparation for installation (e.g. foundations) Operation of the machine without load Testing Trials with load or maximum load Adjustment / setting of safeguards Adjustment / setting of functional parameters Functional tests, trials Programming verification 42 Reference Manual, 09/2011

45 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Lifecycles Operations / tasks / actions (in accordance with EN ISO and EN ISO 12100:2010) Operation Clamping / fastening of the workpiece Cleaning / maintenance (machine designation) Cleaning / maintenance (maintenance equipment) Control / inspection Driving of the machine Loading / unloading of the machine (attachment of ladle / removal of cast product) Minor adjustments and setting of the machine Minor interventions during operation Operation of manual controls Restarting of the machine after stopping Supervision Verification of the final product Adjustments Cleaning Dismantling / removal of parts and devices of the machine Isolation and energy dissipation Lubrication Replacement of tools Replacement of worn parts Resetting Restoring of fluid levels Verification of parts, devices of the machine Adjustments Cleaning Dismantling / removal of parts and devices of the machine Isolation and energy dissipation Lubrication Replacement of tools Replacement of worn parts Resetting Restoring of fluid levels Verification of parts, devices of the machine Reference Manual, 09/

46 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Lifecycles Operations / tasks / actions (in accordance with EN ISO and EN ISO 12100:2010) Fault-finding and troubleshooting (machine designation) Disabling / dismantling Adjustments Dismantling / removal of parts Fault-finding Isolation and energy dissipation Recovery from control and safeguard failures Recovery from jam Repairing Replacement of parts, components, devices of the machine Rescue of trapped persons Resetting Verification of parts, devices of the machine Disconnection and energy dissipation Dismantling Lifting Loading Packing Transportation Unloading EN ISO and EN ISO 12100:2010 define the following hazards: Mechanical hazards Electrical hazards Thermal hazards Noise hazards Vibration hazards Radiation hazards Material / substance hazards Ergonomic hazards Hazards associated with the environment in which the machine is used Combination of hazards The individual lifecycles of a machine are to be examined on the basis of these hazards and their origin. The hazards in accordance with EN ISO and EN ISO 12100:2010 are described in more detail in the following chapters. 44 Reference Manual, 09/2011

47 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Mechanical Hazards Generated by Moved Parts / Equipment or Surfaces Table 3-3 Mechanical hazards Potential hazards generated by Parts / equipment moved in a controlled manner Crushing Shearing Cutting or stabbing Drawing-in or trapping Impact... Parts / equipment moved in an uncontrolled manner, e.g.: Parts / equipment moved in an uncontrolled manner may include: Individual components and component groups Transport goods Mobile or stationary machines Such movements are generally unintended and their effective direction and intensity are difficult to foresee in most cases, e.g.: Crushing Shearing Cutting or stabbing Impact Being run over... Origin Free accessibility Non-observance of safety distances Free accessibility Non-observance of safety distances Tilting Overturning Oscillation Rolling / sliding Falling or loosening Bursting or flying off of parts Ejection of media under pressure or projection of media or workpieces under pressure Reference Manual, 09/

48 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Potential hazards generated by Hazardous surfaces Injuries may be caused by parts featuring hazardous substances in the following locations: In the handling and motion range of persons, e.g. protruding actuators, machine or system parts In confined spaces, e.g. rough surfaces in narrow or low-ceilinged passage ways, little hand clearance At unexpected, temporary obstacles in the walking area, e.g. unexpected opening of doors and gates At tools, workpieces, rubbish Shape and dimensions influence the severity of potential physical injuries. Besides the surface design, the following factors play a role: Intensity of body movement (speed, force, range) Affected body part and its specific resistance Impact Stabbing Cutting Abrasion Rupturing Entanglement / trapping Stumbling Slipping Origin Hazards generated by surfaces originate at / due to: Corners Edges Angular parts Cutting High surface roughness Hazards generated by surfaces may be caused by: Impaired perceptibility of the hazardous surface due to Lack of visibility Insufficient lighting, insufficient contrast Unexpected, sudden appearance of hazardous surfaces Unfavorable range of movement Unfavorable guidance (possibility for contact with hazardous surfaces) Insufficient footprint Insufficient range of movement Forced postures Note Dimensions of hazardous surfaces are not subject to any limit values. The most effective protection against hazardous surfaces lies in the avoidance of contact with hazardous surfaces by persons. 46 Reference Manual, 09/2011

49 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Exemplary measures for risk reduction with hazardous surfaces If hazardous surfaces are unavoidable, the following measures should be taken: Specification of the machine's technological process and directions of movement in a manner which prevents contact to the largest possible extent Arrangement and dimensioning of ranges of movement in a manner which prevents contact with hazardous surfaces with a sufficient safety distance, e.g. by means of: Use of technical aids (e.g. chip remover) Free movement area at the workstation > = 1.5 m² with a lateral length of > = 1.0 m Increased perceptibility through improved lighting Personal protective equipment, e.g. Body protection (gloves, cut-resistant and puncture-resistant clothing DIN EN 340) Foot protection (safety shoes Category S 3 or S 5 in accordance with DIN EN ISO 20345) Head protection (protective helmet) If this is not possible, the harmful effect of such surfaces is to be reduced to a nonhazardous extent, e.g. by means of: Soft, large or resilient contact surfaces Rounding Chamfering Deburring Use of splinter-proof material Cutting edge or edge protection Padding with soft material Covering Surface design No generally valid limit values for the design of corners / angular parts, edges / cutting edges, roughness on moved machine parts exist. Reference values exist for special cases, e.g.: Operator-trapping hazards generated by shaft extensions can be avoided if these extensions do not protrude by more than 0.25 times their diameter or if they feature smooth concentricity and a width of < 50 mm. Reference Manual, 09/

50 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Mechanical Hazards During Normal Operation During normal operation, hazards my be generated by: Overtravel of movements Failure of movement limiters or braking devices Defeating, dismantling, damaging of safeguards In most cases, the reasons for the disuse or disabling of safeguards can be put down to uncomfortable handling, impeded operation processes, convenience and time savings. To rectify faults caused by material jam, intervention in the direct vicinity of hazard zones may be required during ongoing operation. Additional technical and/or organizational protective measures have to be taken for such hazardous situations. Table 3-4 Mechanical hazards, protective measures Protective measure Limitation of forces Recommendations / notes Generally valid recommendations regarding forces and speeds are difficult to make due to the multitude of influencing variables and conditions. This is why limit value specifications for moved machine parts are only available for a small number of cases. DIN EN states the following recommendation for forces: Power-operated doors and gates: Maximum closing force (clamping force) of 150 N Guards are generally not deemed necessary when the maximum force of moved machine parts amounts to 150 N and the contact pressure amounts to < 50 N/cm² Limitation of speeds Narrow points VDI 2854 and DIN EN state the following recommendations for speeds: VDI 2854: For moved parts, e.g. in automatic production systems, the standard specifies a "safely" reduced speed of maximally 25 cm/s for hazardous movements without crushing and shearing hazards (caused by abutting) and of maximally 3.3 cm/s for hazardous movements with crushing and shearing hazards. DIN EN 12203: The reset speed of power-operated guards is to amount to < = 5 cm/s. In accordance with DIN EN 349, hazardous narrow points, mostly in the form of crushing points, are given when the minimum gaps between two moved parts or between one moved and one stationary part are fallen short of in relation to specific body parts. To avoid crushing points in the area of lower extremities (toes, foot, leg), DIN EN ISO "Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs" is to be observed. 48 Reference Manual, 09/2011

51 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Protective measure Safety distances Recommendations / notes The safety distance represents the minimum distance between a person and a hazard zone at which the hazard zone can no longer be reached. Depending on the location of the hazard zone, the arrangement and form of the obstacle (closed or with openings) as well as the movement of the person or the person's body parts, DIN EN ISO "Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs" specifies the following safety distances: Vertical safety distances when reaching upwards (with low and high risk) Horizontal safety distances when reaching over obstacles (with low and high risk) Safety distances when reaching around (for persons aged 14 or older) Safety distances when reaching through openings (for persons aged 3 years or older and aged 14 years or older) Calculation of safety distances Approach speed K Safety distances for protective devices (e.g. trip devices) can be calculated as follows: S = K x T + C S = Minimum safety distance (distance between trip unit of the protective device and hazard zone) K = Approach speed T = Total response time of the protective device C = Additional safety distance The following values can be assumed as approach speed: For movements of body parts (hand, arm, foot movement): 2.0 m/s For whole-body movements: 1.6 m/s The additional safety distance C depends on the approach direction, the means of access to the hazard zone and the type of safeguard (object detection) (DIN EN 13855). Reference Manual, 09/

52 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Electrical Hazards Electrical hazards may cause health damage and may represent the cause of fires and explosions. Electrical hazards generated by electric shocks or arcs can be caused by the use of electricity for works (e.g. use of electrical equipment) or by the implementation of nonelectrical works near live equipment. The type of hazard is determined by the voltage level. In the voltage range up to 1,000 V AC, the electric shock hazards dominate, while arc hazards dominate with voltages exceeding 1,000 V AC. Hazards generated by arcs are owed to their thermal, dynamic and toxic effects on humans. Electric shock or arc hazards are to be expected when: live parts are touched when being approached or various potentials can be bridged the insulation strength can be fallen short of Table 3-5 Electrical hazards Type of electrical hazard Electric shock Effect Electric shock may be caused by: direct contact with live parts of various potential shortfall of the minimum air clearance within the hazard zone due to pre-arcing between the live part and persons Hazards generated by electric shock may occur when the current flowing through the human body increases to a hazardous level in dependency of the resistances in the accident circuit and the driving voltage. This may cause electric marks on the contact points, internal burns, bloodstream coagulation or cardiac fibrillation. Arc Thermal effects: First to fourth degree burns caused by heated gases or metal parts Dynamic effects: Injuries caused by moved parts as a result of pressure buildup in closed rooms with subsequent bursting of the encapsulation. Toxic effects: Intoxication caused by gases or dusts, e.g. by ozone or the decomposition products of sulfur hexafluoride SF6 Actinic effects: Flash burns of the eyes 50 Reference Manual, 09/2011

53 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Thermal Hazards Table 3-6 Thermal hazards Thermal hazard generated by Hot surfaces, e.g.: Annealing furnaces Boiler installations Electrical equipment (heat sinks) Hot media, e.g.: Molten metal Boiling water or grease Refrigerants Leaking media, e.g.: Superheated steam Very cold surfaces, e.g.: Solid carbon dioxide snow Fire and explosion are caused by reactions to or conversions of solid matters, liquids or gases with a high energy release Effect Direct skin contact results in acute injuries caused by burning/scalding Direct skin contact with these media results in acute injuries caused by burning/scalding Direct skin contact with or inhalation of these media results in acute injuries caused by burning/scalding Direct skin contact with these media results in acute injuries caused by local frost bites Burns or hearing damage caused by pressure exposure Note Measures for the prevention or avoidance of direct contact with cold or hot surfaces or emissions are to be taken when designing the machine. Reference Manual, 09/

54 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Noise Hazards The extent of the mentioned health impairments is mainly determined by the parameters of sound pressure level, frequency characteristics (e.g. prominent tone), temporal structure (e.g. impulsiveness) as well as by the period of noise exposure and also depends on the physical and mental constitution of the affected persons. Table 3-7 Noise hazards Noise hazard generated by Audible sound, e.g.: Machine noise Tone Bang Disturbing speech sound Effect Hearing damage Failure to hear warning signals Indisposition and communication disorders Increased risk for the cardiovascular system Diminished capacity of operators The values listed in the following tables indicate the limit values to be met for typical work environments. Table 3-8 Recommended values for the type of activity or room on the basis of DIN EN ISO Type of activity (with examples), type of room Recommended values in db(a) Predominantly mental activities Simple and predominantly routine activities in offices and comparable activities Works on/with machine tools or production machines Manual works Table 3-9 Reference values for noise reduction attainable by means of noise protection measures Noise protection measure Encapsulation Single-leaf, without absorbing lining Single-leaf, with absorbing lining Double-leaf, with absorbing lining and structure-borne sound insulation Sound shielding Without superimposed absorbing ceiling With superimposed absorbing ceiling Sound pressure level reduction in db(a) Up to approx. 5 Up to approx. 10 Sound-proof booth Reference Manual, 09/2011

55 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Vibration Hazards Vibrations represent mechanical oscillations which are transferred to the human body via objects. A differentiation is made between: Whole-body vibrations Caused by vibrations which are generated by mobile equipment, machines and/or vehicles at the work station and are transferred via the seat or the feet Hand-arm vibrations Caused by vibrations which are transferred to hands and arms via the palm and the fingers and which may lead to indirect or direct safety and health risks for the operator Mainly generated by rotating or percussive power tools or by hand-held workpieces during processing Table 3-10 Vibration hazards Vibration hazard generated by Whole-body vibrations Hand-arm vibrations Effect Backache and damage of the spinal column Impaired capacity and well-being Damage of bones or joints, circulatory disorders or neurological diseases Reference Manual, 09/

56 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Radiation Hazards Ionizing radiation Radiation whose energy is sufficient for releasing electrons from an atom or molecule is referred to as ionizing. Fields from 0 Hz to the short-wave UV range do no feature sufficient energy for the dissociation or ionization of molecules and are therefore summarized under the term of non-ionizing radiation. This includes the following: Electromagnetic or electric and magnetic fields Electromagnetic fields are divided into three frequency ranges as both the characteristics and effects as well as the applications correspondingly differ from each other. Optical radiation (e.g. laser) Optical radiation is defined as electromagnetic radiation in the wavelength range from 100 nm to 1 mm. The spectrum of optical radiation is divided into: Ultraviolet radiation (100 nm to 380 nm) Visible radiation (380nm to 780 nm) Infrared radiation (780 nm to 1 mm) Table 3-11 Radiation hazards Radiation hazards generated by Ionizing radiation, e.g.: Short-wave ultraviolet radiation X-radiation Hard gamma radiation Particle radiation Electric, magnetic and electromagnetic fields, e.g.: Geomagnetic field Compensation system 16 2/3 Hz railway systems 50 Hz: Power supply Radio and television stations Mobile radio and radar systems Optical radiation Effect Sunburn Radiation sickness Burn Weakened immune system Genotoxic mutations Sterility Death Static or DC field (0 Hz) Irritation of sensory, neural and muscle cells Low-frequency fields: (> 0 to 30 khz) Irritation of sensory, neural and muscle cells High-frequency fields: 30 khz to 300 GHz) Thermal effects (e.g. microwave cataract) Indirect effects (e.g. leakage currents, electrification, EMC) Eye and skin damage 54 Reference Manual, 09/2011

57 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Material / Substance Hazards Hazardous substances may lead to hazards due to inhalation, thermal decomposition, oxidative auto-ignition, chemical reactions or operational disturbances. The effect of a hazardous substance and the resulting hazard depend on the hazardous substance characteristics and the contamination load (exposure) at the work station. Protective measures have to be employed to reduce operator risks to a minimum. Table 3-12 Material / substance hazards Material / substance hazards generated by Uncontrolled chemical reactions Effect Fire and explosion hazards (also see Thermal Hazards (Page 51)) generated by: Works involving hazardous substances Thermal decomposition Oxidative auto-ignition Further (possibly undesired) chemical reactions of substances or formulations Note In case of explosions, also the respective consequential effects such as high temperature rise and high pressure increase have to be taken into account. Fire and explosion hazards may also arise as a result of operational disturbances. Hazards generated by hazardous substances can be avoided by means of: Extraction systems Use of small substance quantities With solid matters: Use of low-dust forms such as paste, wax, granulate Technical organizational and personal protective measures Operating instructions and instruction of staff Marking of hazardous substances with the "toxic" or "very toxic" hazard symbol Avoidance of skin contact with acid substances Reference Manual, 09/

58 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Ergonomic Hazards - Hazards Generated by the Work Environment The various work environments and conditions may lead to safety and health hazards posed to operators. This may both comprise acute effects and long-term effects which may result in chronic health damage as well as in reduced capacity and discontent of staff. The following physics parameters have to be taken into account: Table 3-13 Ergonomic hazards - hazards generated by the work environment, physics parameters Hazards generated by Climate Air temperature Air humidity Air velocity Thermal radiation (machines, lamps, walls, windows) Effect Premature fatigue Lack of concentration Dehydration Nausea Faint Personal parameters Energetic workload Clothing Illumination, light Mental factors Stress Noise Clock rate Monotonous work Impaired vision Tardy recognition of dangers Short-term, e.g.: Experience of stress, feeling of fatigue, monotony, experience of saturation Capacity fluctuations Increased conflicts with colleagues Diminishing attentiveness, concentration Information loss due to easy distractibility from the work Delayed reaction times Delayed or lacking realization of own mistakes Tendency to reactive instead of foresighted work attitude Long-term or chronic, e.g.: Health problems, psychosomatic disorders and diseases (heart attack, stroke), increased nicotine, alcohol and drug consumption Discontent, resignation, inner resignation, depressive mood, burnout Diminished capacity (due to absence periods, fluctuation, early retirement) The following forms of active physical workload are differentiated: 56 Reference Manual, 09/2011

59 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Manual load handling Lifting, holding, carrying Pulling, pushing Works in forced postures Sitting Standing Forward bending Squatting, kneeling, lying Arms above shoulder level Works involving increased exertion of force and/or application of force Works in difficult to access locations (ascending, climbing) Use of the hand/arm system as tool (knocking, hammering, turning, pressing) Application of force / pressure when operating equipment Repetitive works with high handling frequencies Table 3-14 Ergonomic hazards - hazards generated by the work environment, physical parameters Hazards generated by Strenuous works carried out by hand or arm With exceedance of the following maximum forces: Works carried out by hand (single-handed) Power grip 250 N Works carried out by arm (sitting, single-armed) Upward 50 N Downward 75 N Outward 55 N Inward 75 N Effect Premature fatigue Lack of concentration Chronic joint diseases Reference Manual, 09/

60 Notes on Risk Assessment Implementation 3.2 Step 2: Hazard Identification Note Man-machine / computer interface Information exchange via hardware (actuators, monitors, keyboards) or software (dialogrelated criteria, screen design) forms the basis for man-machine / computer communication. Information absorption, processing and implementation is decisively influenced by the hardware and software design. In addition, further factors such as ambient conditions, work organization, impairment by personal protective equipment and limitation of individual capacity prerequisites have to be considered. A non-ergonomic design of machine control elements may lead to maloperation and corresponding hazards. When designing the man-machine / computer interface, all senses via which the operator is able to absorb process information (see table "Information and addressed sensorial areas") as well as the correlation between function and natural direction of motion (see table "Preferred direction of motion of actuators") have to be taken into account. Table 3-15 Information and addressed sensorial areas Information to be absorbed (process characteristics) Operating noise of a motor Shape of removed chips (position of actuators) Burning smell Vibration of a system Danger signals (e.g. horn, siren, hazard flasher) Safety markings and warnings Display of operating states (e.g. monitor, instruments) Addressed sensorial areas Hearing Seeing Smelling Motion perception (feeling) Seeing, hearing Seeing Seeing Table 3-16 Preferred direction of motion of actuators Function Direction of motion Exception On Off Right Left Lifting Lowering Retracting Extending Increasing Reducing Upward, to the right, forward, in clockwise direction, pulling Downward, to the left, backward, in anti-clockwise direction, pushing In clockwise direction, to the right In anti-clockwise direction, to the left Upward, backward Downward, forward Upward, backward, pulling Downward, forward, pushing Forward, upward, to the right, in clockwise direction Backward, downward, to the left, in anti-clockwise direction Valve opening in anti-clockwise direction Valve closing in clockwise direction See also Risk Matrix (Page 61) 58 Reference Manual, 09/2011

61 Notes on Risk Assessment Implementation 3.3 Step 3: Risk Estimation 3.3 Step 3: Risk Estimation Once all hazards have been determined, the risk estimation is carried out. In this context, EN ISO and EN ISO 12100:2010 specify two risk elements which have to be determined for each identified hazard. Risk Severity of harm Probability of occurrence of the harm is a function of and Figure 3-1 Risk elements in accordance with EN ISO and EN ISO 12100:2010 According to this specification, the risk depends on the estimation of the severity and the probability of occurrence of the possible harm. In turn, the probability of occurrence of the possible harm depends on the estimation of the frequency and duration of exposure to hazard, the probability of occurrence of the hazardous event as well as the possibility to avoid or limit the harm. Employed procedures for the analysis of hazards and the estimation of risks comprise: Risk graph in accordance with ISO Risk table in accordance with EN Failure mode effects analysis (FMEA) in accordance with EN This guideline describes the procedures in accordance with EN ISO and EN Reference Manual, 09/

62 Notes on Risk Assessment Implementation 3.4 Step 4: Risk Evaluation 3.4 Step 4: Risk Evaluation Following risk estimation, risk evaluation has to be carried out in order to determine whether risk reduction is required. As risk evaluation is based on subjective aspects, experts are required for deciding on adequate risk reduction within the scope of risk evaluation on the basis of profound knowledge of state-of-the-art technology and gained experience. It is therefore generally recommendable to set up a risk evaluation team which comprises all persons involved in the design and development of the machine / system, e.g. from the following disciplines: Mechanical design Electrical design Fluidics (hydraulics, pneumatics,...) Software creation Documentation Risk Matrix (Explanations) The determination of reasonable measures for realizing the required risk reduction is often difficult for designers and developers in practice. The risk matrix contained in chapter "Risk Matrix (Page 61)" offers support in this context. Targets of risk evaluation: 1. General estimation of a danger 2. Comprehendible documentation of the estimation 3. Recommendation of measures for design, development, documentation and decisionmakers based on the estimation The following procedure suggests itself: 1. The general (original) risk, i.e. without any protective measure, is evaluated on the basis of the matrix 2. The risk is reduced after initiation of a measure (risk-reducing measure), e.g. from 3 A (risk before) to 2 B or 1 B (risk after) 3. If this is not sufficient, several risk-reducing measures have to be taken to attain the final evaluation "no further measures required" (green fields in the risk matrix) 60 Reference Manual, 09/2011

63 Notes on Risk Assessment Implementation 3.4 Step 4: Risk Evaluation Risk Matrix Design evaluation and determination of measures on the basis of the risk matrix. The first-time evaluation of a risk represents the original risk! Probability of occurrence Severity of harm A B C Probable Possible Improbable 4 Irreversible: Death, loss of an eye or arm 3 Irreversible: Broken limbs, loss of finger(s) 2 Reversible: Medical treatment required 1 Reversible: First aid required Meaning of colors The color red indicates a high risk. This has to be preferably reduced by means of design measures (Dm, De, Df). Other measures for risk reduction must only be initiated in individual cases where this is not permitted by the production process. The color yellow indicates a lesser risk than red. Such risk can either be reduced by means of design measures or technical protective measures (mechanical, electrotechnical FS). The color green indicates residual risks which do not require any further (design) measures. However, quality assurance measures or personal protective equipment may be required. CAUTION Design measures are not necessarily quantitatively measurable. Example: Crushing hazards have to be generally prevented by means of a protective guard or sufficient distances. This for example applies to 3 A as well as 3 B. Technical protective measures in connection with a control system (safety functions) are qualitatively and quantitatively measurable on the basis of the required safety integrity level (SIL or PL). Example: In 3 A, SIL 3 or PL e may be required, whereas SIL 2 or PL d may be required in 3 B. Reference Manual, 09/

64 Notes on Risk Assessment Implementation 3.4 Step 4: Risk Evaluation Table 3-17 Type of measures Type of measures Examples Design measure Inherently safe design measure: Travel limitation; cover Technical protective measure Guard: Protective fence, door or flap; light curtain; two-hand operation console At least warnings required Standardized pictograms: Hearing protection,... No further measures required Instruction handbook; organizational if applicable Table 3-18 Abbreviation D e, f, m FS W IH PPE ORG Abbreviation of the protective measure Description of the protective measure Design (electrical, fluidic, mechanical) Functional safety (control technology measure) safety function Warning on the machine Note in the instruction handbook or maintenance handbook Personal protective equipment Organizational protective measure Severity of harm and probability of occurrence are defined as follows: Table 3-19 Severity of harm Classification Description 4 Fatal or severe irreversible injury whose nature will make it very difficult for the injured person to carry out the same work after healing, if healing is possible at all 3 Major or irreversible injury whose nature will allow the injured person to carry out the same work after healing, e.g. healed fractures of limbs never attain the same stability as before such fracture, hence irreversible! 2 Reversible injury, including severe flesh wounds, stab wounds and severe crushes, which requires medical treatment 1 Minor injury, including scratches and minor crushes, which requires first aid treatment 62 Reference Manual, 09/2011

65 Notes on Risk Assessment Implementation 3.4 Step 4: Risk Evaluation Table 3-20 Classification Probable (high) Possible (average) Improbable (low) Probability of occurrence Possible determination on the basis of risk elements Exposure to hazard Occurrence of hazardous events Possibilities of avoidance Exposure to hazard Occurrence of hazardous events Possibilities of avoidance Exposure to hazard Occurrence of hazardous events Possibilities of avoidance Normal operation; frequent (> 1 per shift, several times per day) Unexpected event; stress (time pressure) Qualified or trained staff No sudden or rapid movements Sufficient workspace Normal operation or maintenance; rather infrequent (< 1 per shift, < 1 per day) Conscious event and corresponding actions Qualified staff No sudden or rapid movements Repair; seldom (< 1 per week or month) Conscious event and corresponding actions Qualified staff No sudden or rapid movements Table 3-21 Risk elements and typical influencing factors Risk elements (EN ISO ) Exposure to hazard Occurrence of hazardous events Possibilities of avoiding or limiting a harm Typical influencing factors Need for access to the hazard zone (for normal operation, correction of malfunction, maintenance, ) Nature of access (for example, manual feeding of materials) Time spent in the hazard zone Frequency of access Foreseeability of the behavior of the machine's components (reliability data, accident history, ) Foreseeable characteristics of human behavior (stress, lack of awareness regarding the hazard, ) Data on damage to health Risk comparisons Qualified or trained staff Risk awareness and practical experience Human ability to avoid or limit harm (by means of reflex, agility, possibilities of escape Reference Manual, 09/

66 Notes on Risk Assessment Implementation 3.5 Step 5: Risk Reduction 3.5 Step 5: Risk Reduction Adequate risk reduction is to be ensured by implementation of the following steps ("threestep method"): Step 1: Elimination or reduction of design risks Step 2: Initiation of technical protective measures against risks which cannot be eliminated Step 3: Information of users on residual risks and their avoidance Design measures always take precedence. In cases where this is not possible due to process reasons, risk reduction by means of technical safeguards may be considered. Measures of a lower step must only be taken when the risk cannot be sufficiently reduced with measures of a higher step. Examples of elimination or reduction of design risks: Observance of minimum distances Observance of safety distances Limitation of energy Flux interruption Elastic deformation... Examples of risk reduction by means of safeguarding: Guards Permanent Movable Adjustable Protective devices Interlocking devices Enabling devices... Impeding devices... Some safeguards can only be used for risk reduction in combination with safety functions. The safety functions can be realized by means of mechanical, pneumatic, hydraulic, electrical, electronic or programmable components or a combination thereof. EN ISO as well as EN offer support with the design and assessment of machine control systems (safety functions). 64 Reference Manual, 09/2011

67 Notes on Risk Assessment Implementation 3.6 Step 6: Realization of Safety Functions 3.6 Step 6: Realization of Safety Functions Risk reduction measures are defined for every possible risk of a machine or system, for example in the form of safety functions. These measures serve the maintenance or restoration of a safe system state. It is recommendable to initially specify the safety function's definition. This comprises a description of the safety function as well as the required Safety Integrity Level (SIL in accordance with EN 62061) or Performance Level (PL in accordance with EN ISO ) according to the risk estimation. Table 3-22 Example: SIL determination No. Name of the safety function Risk classification Description of the safety function Measures / test criterion S Severity F Frequency P Probability A Avoidance C Class SIL 1, 2, 3 1 Name of the safety function Description of the safety function Table 3-23 Example: PL determination No. Name of the safety function Risk classification Description of the safety function Measures / test criterion S Severity F Frequency A Avoidance PL a, b, c, d, e 1 Name of the safety function Description of the safety function Reference Manual, 09/

68 Notes on Risk Assessment Implementation 3.7 Software Requirements 3.7 Software Requirements The following aspects have to be additionally considered for safety-related software: Development process (V model) Use of certified modules Test and release procedures Configuration management 3.8 Notes on Verification Technical safeguards or parts of machine control systems which carry out protective measures are referred to as safety-related parts of control systems, whose design and assessment is described in the harmonized standards EN ISO and EN The control parts have to be designed in a manner which ensures that the control function's safety as well as the control's behavior in case of fault correspond to the degree of risk reduction determined within the scope of risk assessment. Furthermore, the manufacturer is obliged to point out any residual risks in the instruction handbook and to identify respective risks in the form of warnings on the machine. This ensures that any residual risks posed by the machine are detected and reduced to a minimum in accordance with "state-of-the-art technology". This description largely corresponds to the description of the above-described risk assessment with regard to contents and is therefore transferable. 66 Reference Manual, 09/2011

69 Reevaluation of Realized Safety-Related Control 4 Systems 4.1 From EN to Functional Safety The Machinery Directive obliges the manufacturer to implement a risk analysis for the systematic determination of dangers, hazards and risks and for the definition of safety measures in accordance with the respective results. Hitherto, risk analysis was based on the standard EN 1050 and determination of the required category was based on the standard EN These standards were revised and replaced by new standards. The revised requirements are specified in the standards EN and EN for risk evaluation and the realization of safety functions, in EN ISO or, alternatively, in EN The procedure for the reevaluation of already realized control systems in accordance with the requirements of the two new standards is described in the following. Reference Manual, 09/

70 Reevaluation of Realized Safety-Related Control Systems 4.1 From EN to Functional Safety EN ISO Title of EN ISO : "Safety-related parts of control systems - Part 1 General principles for design" This standard may be applied to safety-related parts of control systems (SRP/CS) and to all types of machinery, irrespective of the employed technology and energy (electrical, hydraulic, pneumatic, mechanical, etc.). EN ISO also specifies special requirements for SRP/CS with programmable electronic systems. Advantage The known categories can be further used. Disadvantage The calculation method is informative. Note The term normative refers to requirements which have to be met. The term informative refers to further information. Application of EN ISO :2006 EN ISO is advantageous for the evaluation of simple controls whose architectures are accurately defined on the basis of categories B, 1 to 4. More complex distributed systems or systems comprising complex electronics which do not go beyond PL = d require a more extensive evaluation. Evaluation can be divided into the following steps: Risk assessment implementation - determination of required measures for risk reduction (PLr) Definition of requirements in terms of fail-safe operation (categories) Determination of MTTFd for electrical, electromechanical and mechanical components (B10 method) Classification of MTTFd Evaluation of diagnostics measures, determination of DCavg Assessment of measures against common cause failures (in accordance with the check list defined in the standard) Determination of the attained Performance Level PL Safety verification in accordance with EN ISO (e.g. test report) 68 Reference Manual, 09/2011

71 Reevaluation of Realized Safety-Related Control Systems 4.1 From EN to Functional Safety EN Title of EN 62061: "Functional safety of safety-related electrical, electronic and programmable electronic control systems" This standard specifies requirements and provides recommendations for the design, integration and validation of safety-related electrical, electronic and programmable electronic control systems (SRECS). It does not define any requirements for the capacity of nonelectrical (e.g. hydraulic, pneumatic, electromechanical) safety-related control elements for machines. However, the respective evaluation methods can be adopted! Advantage The used architectures are flexibly applicable. The calculation method is normative. Disadvantage The term category is described with the architectures. The formulas are more complex and depend on the system architecture. Application of EN EN can be applied for the evaluation of all electrical and electronic systems, independently of their category. Although not clearly indicated by the formulation of the standard's title and application area, the requirements can also be applied to non-electrical control systems. Evaluation can be divided into the following steps: Determination of required measures for risk reduction (SILr) Measures for fault avoidance (QM) during the various phases and throughout the product lifecycle Requirements placed upon the quality assurance system (functional safety management) Requirements placed upon fail-safe operation (SFF) in dependence of the architecture (HFT) as well as the SIL (probabilistic fault analysis) Requirements placed upon the design of user software and configuration management Determination of the attained Safety Integrity Level SIL Safety verification in accordance with EN (e.g. test report) Reference Manual, 09/

72 Reevaluation of Realized Safety-Related Control Systems 4.2 Previous Application of EN Previous Application of EN Previously, the following steps had to be carried out for the realization of control systems in accordance with EN 954-1: 1. Risk assessment implementation 2. Determination of measures for risk reduction 3. For control systems: Determination of the required category in accordance with EN on the basis of the risk graph (informative) 4. Determination of category B, 1 to 4 in accordance with EN Implementation of failure mode effects analyses (FMEA) in consideration of fault models 6. Safety verification in accordance with EN The basic system for risk evaluation implementation remains unchanged in all mentioned standards. New contents include the method for the determination of requirements for safety-related control systems and the required probabilistic values (probabilities) and methods for verification of compliance with the requirements. 70 Reference Manual, 09/2011

73 Reevaluation of Realized Safety-Related Control Systems 4.3 Steps for Reevaluation 4.3 Steps for Reevaluation Prerequisites for Reevaluation Complete risk evaluation in accordance with EN 1050 Determination of the category in accordance with EN Availability of the safety function's pneumatic / hydraulic / circuit diagram Determination of employed components Determination of the standard for the safety function's evaluation Review of the existing risk analysis Conversion of risk graphs Conversion of risk graphs in accordance with EN to risk graphs in accordance with EN ISO Result: PL OR Conversion of risk graphs in accordance with EN to risk matrix in accordance with EN Result: SIL Calculation of probabilistic values or obtaining from component manufacturer (see "Typical Layout of a Safety Function (Page 93)") Adoption of category (EN ISO ) or determination of architecture (EN 62061) (see "Typical Layout of a Safety Function (Page 93)") Calculation of the attained PL or SIL (see "Typical Layout of a Safety Function (Page 93)") Determination of the Standard for the Safety Function's Evaluation The standard to be applied can be determined in accordance with table 1 (EN ISO or EN 62061). Application of the standard's risk graph or risk matrix depends on this determination. Reference Manual, 09/

74 Reevaluation of Realized Safety-Related Control Systems 4.3 Steps for Reevaluation Procedure in Accordance with EN ISO Conversion of risk graphs to EN Figure 4-1 Comparison of risk graphs Severity of harm S S1 minor injury S2 severe injury Frequency F1 seldom F2 more often Possibility of avoidance A1 possible A2 not possible The two risk graphs show that parameters F and A have to be reevaluated for severity of harm S1 (low) in order to determine the required PL a, b or c. The PL values required for S2 are directly indicated. Design of the safety function An estimation of the PL has to be implemented for each selected SRP/CS and/or the combination of SRP/CS which carries out a safety function. The category in accordance with EN can be adopted. Together with further values (see "Typical Layout of a Safety Function (Page 93)"), the category forms the basis for the calculation of the PL: 72 Reference Manual, 09/2011

75 Reevaluation of Realized Safety-Related Control Systems 4.3 Steps for Reevaluation Calculation of probabilistic values or obtaining from component manufacturer (see "Typical Layout of a Safety Function (Page 93)") The PL of the SRP/CS has to be determined by estimation of the following parameters: MTTFd value of the individual components Diagnostic coverage - DC Common cause failures - CCF Category in accordance with EN Calculation of the attained PL (PFHD). Reference Manual, 09/

76 Reevaluation of Realized Safety-Related Control Systems 4.3 Steps for Reevaluation Procedure in Accordance with EN Conversion of risk graphs to EN The risk graph in accordance with EN cannot be converted to the risk matrix in accordance with EN Even though the category cannot be adopted, it can be converted to an architecture (see "Typical Layout of a Safety Function (Page 93)"). EN uses a table for determination of the required SIL for risk evaluation implementation (see illustration below). The risk of every hazard is estimated on the basis of the risk elements' determination: Severity of harm, S Frequency and duration of a person's exposure to hazard, F Probability of occurrence of a hazardous event, P Possibilities of avoiding or limiting the harm, A Risk assessment and safety measures Document No.: Part: Product: Manufacturer: Date: Preliminary risk assessment Interim risk assessment Subsequent risk assessment Severity of Effects harm S Death, loss of an eye or arm 4 Permanent, loss of fingers Reversible, medical treatment Reversible, first aid Class C SIL 2 SIL 2 SIL 2 SIL 3 SIL 3 OM SIL 1 SIL 2 SIL 3 OM SIL 1 SIL 2 OM SIL 1 Probability of occurrence of the hazardous event Frequency and/or duration of exposure F P 1 per h 5 Frequent 5 < 1 per h to 1 per day 5 Probable 4 < 1 per day to 1 per 14 days 4 Possible 3 < 1 per 2 weeks to 1 per year 3 Seldom 2 < 1 per year 2 Negligible 1 Possibility of avoidance A Impossible Possible Probable Ser. Hazard No. No. Hazard S F P A C Safety number Safe Comments Figure 4-2 Table for risk assessment implementation in accordance with EN 62061, Annex A C= F+P+A 74 Reference Manual, 09/2011

77 Reevaluation of Realized Safety-Related Control Systems 4.3 Steps for Reevaluation Design of the safety function The selection or design of the SRECS generally has to meet the following requirements at least. Requirements placed upon the hardware's safety integrity, consisting of: Architectural constraints of a hardware's safety integrity Requirements regarding the probability of hazardous random hardware failures Requirements placed upon systematic safety integrity, consisting of: Requirements regarding the avoidance of failures Requirements regarding the control of systematic faults Requirements placed upon the realization of application programs Calculation of probabilistic values or obtaining from component manufacturer (see "Typical Layout of a Safety Function (Page 93)"). Safety-technical characteristics: SILCL: SIL claim limit PFHD: Probability of dangerous failure per hour T1: Life limit T2: Test interval Calculation of the attained SIL (PFHD). Reference Manual, 09/

78 Reevaluation of Realized Safety-Related Control Systems 4.3 Steps for Reevaluation 76 Reference Manual, 09/2011

79 Further Information Basic Contents of Technical Documents Table 5-1 Basic contents of the instruction handbook Instruction handbook > General Instruction handbook, including all contained auxiliary equipment, with determination of machinespecific characteristics and measures Instruction handbook > Information on the machine / equipment Information on the machine / equipment regarding: 1. Manufacturer, type of machine / equipment, year of construction, serial number / machine number 2. Technical documents (circuit diagrams, overview drawing; complete detailed drawing with calculations, test results, etc.; risk assessment documents, data sheets, information / notes on spare parts) on the intended use 3. Information on interfaces of additional / optional machines / equipment for use not as intended 4. Description of auxiliary equipment and integration of such equipment in the control (e.g. EMERGENCY-STOP, effect on safeguards) 5. Machine-specific characteristics and measures 6. List of applied standards and further technical specifications 7. Technical test reports 8. With series production: Notes on quality assurance Instruction handbook > Instructions on transport, assembly / installation Instructions on transport, assembly / installation regarding: 1. Instructions for lifting 2. Transport weight 3. Safety equipment for transport and removal of such equipment prior to commissioning 4. Installation diagram / assembly conditions 5. Notes on the assembly / mounting of the machine / equipment or individual machine parts 6. Information regarding protection against collapsing and falling from high altitudes Instruction handbook > Information on commissioning and dismantling Information on commissioning and dismantling regarding: Power supply (electrical, hydraulic, pneumatic, etc.) Filling levels / liquid specifications Attachment of auxiliary equipment Switch-on, operation and switch-off Inspection of safety equipment prior to commissioning Prohibition of unauthorized conversions and modifications Notes on dismantling Reference Manual, 09/

80 Further Information 5.1 Basic Contents of Technical Documents Instruction handbook > Instructions on equipment Instructions on equipment regarding: Available safeguards Regular inspection of safeguards Characteristic hazards (e.g. electrics, hydraulics, special notes on process changeover and re-commissioning after process changeover) Processing of materials which set harmful substances free such as gas, smoke or dust Description of safety-related control systems Information on noise development and recommendations if required, e.g. for: Covers and shields Use of cabins for operating personnel Use of hearing protection Signage of noisy areas Operators: Notes on the required qualification of operating staff Instruction of the operator on machine / equipment operation New personnel has to be trained prior to starting any works Instruction regarding safety equipment and proceeding in case of accidents Measures (fault rectification) in case of defects or irregularities as well as abnormal operation Notes on residual risks, for example: Radiation Hot surfaces in the working area Ejection of material or product parts Notes on special hazards when accessing a machine for special reasons (maintenance, fault rectification) Notes on hazards generated by: Lacking depressurization Malfunctions of programmable electronic control systems Temperature / fire Instruction handbook > Special instructions Special instructions regarding: Fault rectification during operation, e.g.: Access to the hazardous area is only permitted to authorized and trained personnel For fault rectification, the personnel has to be informed on special precautionary measures for the respective situation in accordance with the risk evaluation Maintenance, e.g.: Access to the hazardous area is only permitted to authorized and trained personnel The maintenance personnel has to be informed on residual risks and interlocking equipment 78 Reference Manual, 09/2011

81 Further Information 5.2 Safety Layout Plan Further accompanying documents Table 5-2 Maintenance handbook, instructions Maintenance handbook > Instructions Typical instructions on: Function checks / tests to be implemented Maintenance works Repair works Protective measures against hazards Notes on maintenance works which require special knowledge or qualifications Spare parts lists with reference to the respective drawings or circuit diagrams Regular inspection of safety equipment (determination of the frequency of such inspections, depending on the equipment's reliability, nature and significance) Preventive measures (e.g. replacement of worn parts, lubrication, etc.) Fault messages of the control system and respective measures to be initiated Fault list with indication of causes and measures to be initiated Parts of the system/systems which have to be disconnected during repair works Remaining residual energy (hydraulic accumulator, etc.) and reduction of such energy (only where required) 5.2 Safety Layout Plan Safety layout plans with information and schematic representation regarding: Hazardous areas Emergency equipment Access doors EMERGENCY-STOP buttons Warnings Reference Manual, 09/

82 Further Information 5.3 General Protective Measures 5.3 General Protective Measures Table 5-3 Protective measures, hydraulic and pneumatic systems Hydraulic and pneumatic systems Requirement Compliance with the standard EN 983 Safety requirements for fluid power systems and their components / pneumatics Hazard / risk High pressure / breakage during operation / high pressure fluid ejection Slippery surfaces Objects or materials subject to high temperatures / radiation from heat sources Explosion / flames Measures Warning in exposed areas > represented in the safety layout plan Selection of components (pipes, fittings, hoses, armatures) in consideration of the respective max. pressure load Observance of the avoidance of pressure peaks by application of suitable components (e.g. pump controllers, soft-switching valves) Covers for flanges, armatures: Routing of hydraulic components (pipes, fittings, hoses, armatures) Slip-resistant floor design of all access points, exit points, walkways, working platforms, stairs and covers in all walking and working areas (e.g. grillage, checker plate) Discharge of hydraulic liquids Protective covers (where operationally and technically possible) for parts exceeding 60 C Temperature indicators on the individual hydraulic systems Failure / alarm indicators (visual) on the individual hydraulic systems Cooler for hydraulic systems 80 Reference Manual, 09/2011

83 Further Information 5.4 Personal Protective Equipment (PPE) 5.4 Personal Protective Equipment (PPE) According to the European Directive 89/686/EEC published on December 21, 1989, the term personal protective equipment (PPE) refers to all equipment and means intended to be worn or carried by a person for protection against one or multiple hazards which could endanger the health and safety of this person. Amongst others, the PPE group comprises: Belts Helmets Lanyards Energy absorbers Temporary stop mechanisms Shoring equipment Descender devices Rope clamps Connecting elements Deflection pulleys Guided fall arresters Ropes... Depending on the risk level, PPE is divided into three categories: Cat. 1: Low risks = mechanical impact, solar irradiation, e.g. weather-appropriate clothing, sunglasses / wind protection glasses Cat. 2: Serious risks, e.g. protective gloves, hearing protection, protective helmets, safety shoes Cat. 3: Severe or life-threatening risks, e.g. respiratory protective equipment, anti-fall guards Certification requirements for PPE: Cat. 1: Low risks - certification by manufacturer Cat. 2: Serious risks - CE type test Cat. 3: Severe or life-threatening risks - CE type test and certified quality management, or Type examination with indication of the test laboratory's identification marking Reference Manual, 09/

84 Further Information 5.4 Personal Protective Equipment (PPE) Inspection and maintenance of PPE In accordance with the 89/656/EC directive, all PPE has to be inspected prior to every use and on a periodical basis. The manufacturer determines the criteria and restrictions of such inspections: Shorter inspection intervals may be recommended. The purpose of such inspections lies in the early detection of any damage or wear signs of the equipment which may lead to hazardous situations. PPE has to be inspected: Prior to every commissioning and personal assignment, by the user Prior to and after every use, by the user Every three months (detailed inspection) The manufacturer's specifications regarding the life limit have to be observed, e.g. 6 months with intensive use, 12 months with normal use and maximally 10 years with occasional use. Table 5-4 Personal protective equipment Personal protective equipment Requirement Specification of certified PPE, in accordance with the 89/686/EEC directive Hazard / risk Sharp corners and edges Falling objects Falling Slippery surfaces Substances or materials subject to high temperatures or flames Radiation of heat sources Laser radiation Excessive noise Contact with hazardous substances Liquids, vapors, gases, mists, dusts High pressure Contact with contaminated water Measures Protective gloves Protective helmet Safety belt Safety shoes Heat protection equipment Heat protection equipment Goggles Hearing protection Chemical protection gloves Chemical protection gloves, goggles, protective suits, breathing helmets Protective gloves, protective clothing Protective gloves 82 Reference Manual, 09/2011

85 Further Information 5.5 Safety Distances in Accordance with EN ISO Safety Distances in Accordance with EN ISO Table 5-5 Reaching around with limitation of movement, table 3 of EN ISO Limitation of movement Safety distance Figure Limitation of movement only at shoulder and armpit 850 Arm to elbow supported 550 Arm to wrist supported 230 Reference Manual, 09/

86 Further Information 5.5 Safety Distances in Accordance with EN ISO Limitation of movement Arm and hand to base of the finger supported 130 Safety distance Figure A Motion range of the arm sr Radial safety distance a Either diameter of a circular opening or side of a square opening or width of a slit-shaped opening Dimensions in millimeters Table 5-6 Reaching through regular openings persons of 14 years of age and above, table 4 of EN ISO Body part Figure Opening Safety distance sr Slit-shaped Square Circular Finger tip e < e Finger to base of 6 < e finger 8 < e Hand 10 < e < e < e a Reference Manual, 09/2011

87 Further Information 5.5 Safety Distances in Accordance with EN ISO Body part Figure Opening Safety distance sr Arm to shoulder joint Slit-shaped Square Circular 30 < e < e The fat lines in the table indicate the body part which is limited by the size of the opening. a If the length of a slit-type opening amounts to 65 mm, the thumb serves as limitation and the safety distance can be reduced to 200 mm. Dimensions in millimeters Reference Manual, 09/

88 Further Information 5.5 Safety Distances in Accordance with EN ISO Table 5-7 Reaching through openings of regular shape by lower limbs, table 7 of EN ISO Part of the lower limb Figure Opening Safety distance sr Slit-shaped Square or circular Tip of the toe e < e Toe 15 < e 35 80a 25 Foot 35 < e < e b 180 Leg (tip of toe to knee) 80 < e c 650b Leg (tip of toe to 95 < e c 1 100c crotch) 180 < e 240 Impermissible 1 100c a If the length of the slit-type opening amounts to 75 mm, the distance can be reduced to 50 mm. b The value refers to the leg (tip of toe to knee) c The value refers to the leg (tip of toe to crotch) NOTE Slit-type openings with e > 180 mm and square or circular openings with e > 240 mm permit access by the entire body (also see clause 1, last paragraph). Dimensions in millimeters 86 Reference Manual, 09/2011

89 Further Information 5.6 General Safety Notes 5.6 General Safety Notes General Excerpt from ProdSG (German Product Safety Law): The responsible authority [...] shall in particular be entitled [...] to request the attachment of appropriate, clearly and easily understandable warnings against hazards posed by the product These warnings are to be formulated in German Principles for hazard notes Concrete naming of the hazard Clear emphasis of the hazard type The hazard is NOT only recognized by the user as a result of his own thinking or conclusions Indication of all risks / possible consequences Easily understandable explanation of the functional correlation between the use of the product and possible harm Clear indication when and why the product may pose hazards Risk and consequence descriptions have to be comprehendible and perceived as plausible by the user Justification of behavior patterns for risk avoidance Design of notes in a manner which ensures perception by the addressee Editorial specifications may include: Optimum readability of letters (font and size) Emphasis of safety notes by means of colors, symbols and/or large letter size Clear differentiation of languages with multilingual notes Use of illustrations whenever possible Positioning of illustrations in the sequence of operations Positioning of illustrations close to the text Supplementation of illustrations with text, no separation from accompanying text Inclusion of tables whenever helpful for understanding Positioning of tables beside the accompanying text Consideration of the use of colors (for components requiring quick identification) Inclusion of table of contents and index with lengthy instructions, production in endurable form Reference Manual, 09/

90 Further Information 5.7 Warning Devices and Safety Labels 5.7 Warning Devices and Safety Labels Table 5-8 Warning devices and safety labels Warning devices and safety labels Requirement Design of visual and auditory danger signals regarding: Reduction of risks associated with the misinterpretation of visual and auditory signals Clear perception and differentiation of danger / information signals in accordance with the requirements of the standard EN 981 Design of visible, audible and tactile safety information as well as determination of colors, safety signs, markings and other warnings in accordance with the requirements of the standard EN Easily visible positioning of visual warning devices Design and dimensioning of auditory warning devices in a manner which ensures that the sound power level lies at least 10 db above the running system's ambient noise within a distance of 7 m from the warning device Marking of all mechanical, fluidic and electrical connections on the machine and machine parts if required for the assurance of proper connections (prevention of incorrect connections), in accordance with the requirements of the standard EN Design of graphical symbols attached to the machine / machine parts in accordance with the representations included in the standard ISO 7000/701 Figure 5-1 Examples of safety labels 88 Reference Manual, 09/2011