Information and Notices

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1 Official Journal of the European Union ISSN C 183 English edition Information and Notices Volume 53 7 July 2010 Notice No Contents Page IV Notices NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGCIES European Commission 2010/C 183/01 Commission communication in the framework of the implementation of the Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres ( 1 ) (Publication of titles and references of harmonised s under the directive) /C 183/02 Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 1 ) (Publication of titles and references of harmonised s under the directive) /C 183/03 Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 1 ) (Publication of titles and references of harmonised s under the directive) /C 183/04 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 1 ) (Publication of titles and references of harmonised s under the directive) Price: EUR 4 ( 1 ) Text with EEA relevance

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3 Official Journal of the European Union C 183/1 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGCIES EUROPEAN COMMISSION Commission communication in the framework of the implementation of the Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (Text with EEA relevance) (Publication of titles and references of harmonised s under the directive) (2010/C 183/01) superseded C 809:1998+A1:2009 Pumps and pump units for liquids - Common safety requirements C :2004 Safety of machinery - Safety requirements for the design and construction of printing and paper converting machines - Part 1: Common requirements C :2006 Safety of machinery - Safety requirements for the design and construction of printing and paper converting machines - Part 2: Printing and varnishing machines including pre-press machinery C :2007 Explosive atmospheres - Explosion prevention and protection - Part 1: Basic concepts and methodology :1997 ( ) C :2002+A1:2008 Explosive atmospheres - Explosion prevention and protection - Part 2: Basic concepts and methodology for mining :2002 ( ) C 1710:2005+A1:2008 Equipment and components intended for use in potentially explosive atmospheres in underground mines :2005 ( ) C 1755:2000+A1:2009 Safety of industrial trucks - Operation in potentially explosive atmospheres - Use in flammable gas, vapour, mist and dust :2000 ( )

4 C 183/2 Official Journal of the European Union superseded C :2000 Reciprocating internal combustion engines - Safety requirements for design and construction of engines for use in potentially explosive atmospheres - Part 1: Group II engines for use in flammable gas and vapour atmospheres C :2000 Reciprocating internal combustion engines - Safety requirements for design and construction of engines for use in potentially explosive atmospheres - Part 2: Group I engines for use in underground workings susceptible to firedamp and/or combustible dust C :2000 Reciprocating internal combustion engines - Safety requirements for design and construction of engines for use in potentially explosive atmospheres - Part 3: Group II engines for use in flammable dust atmospheres C 1839:2003 Determination of explosion limits of gases and vapours C 12581:2005 Coating plants - Machinery for dip coating and electrodeposition of organic liquid coating material - Safety requirements C 12621:2006 Machinery for the supply and circulation of coating materials under pressure - Safety requirements C :2005 Mixing machinery for coating materials - Safety requirements - Part 1: Mixing machinery for use in vehicle refinishing C 12874:2001 Flame arresters - Performance requirements, test methods and limits for use C 13012:2001 Petrol filling stations - Construction and performance of automatic nozzles for use on fuel dispensers C :2003 Leak detection systems - Part 1: General principles C 13237:2003 Potentially explosive atmospheres - Terms and definitions for equipment and protective systems intended for use in potentially explosive atmospheres C :2009 Non-electrical equipment for use in potentially explosive atmospheres - Part 1: Basic method and requirements C :2004 Non-electrical equipment for use in potentially explosive atmospheres - Part 2: Protection by flow restricting enclosure fr : ( )

5 Official Journal of the European Union C 183/3 superseded C :2005 Non-electrical equipment for use in potentially explosive atmospheres - Part 3: Protection by flameproof enclosure d C :2003 Non-electrical equipment intended for use in potentially explosive atmospheres - Part 5: Protection by constructional safety c C :2005 Non-electrical equipment for use in potentially explosive atmospheres - Part 6: Protection by control of ignition source b C :2003 Non-electrical equipment for potentially explosive atmospheres - Part 8: Protection by liquid immersion k C 13616:2004 Overfill prevention devices for static tanks for liquid petroleum fuels :2004/AC:2006 C :2004+A1:2009 Petrol filling stations - Part 1: Safety requirements for construction and performance of metering pumps, dispensers and remote pumping units :2004 The date of this C :2004 Petrol filling stations - Part 2: Safety requirements for construction and performance of safe breaks for use on metering pumps and dispensers C :2004 Petrol filling stations - Part 3: Safety requirements for construction and performance of shear valves C :2003 Determination of the maximum explosion pressure and the maximum rate of pressure rise of gases and vapours - Part 1: Determination of the maximum explosion pressure C :2005 Determination of maximum explosion pressure and the maximum rate of pressure rise of gases and vapours - Part 2: Determination of the maximum rate of explosion pressure rise C 13760:2003 Automotive LPG filling system for light and heavy duty vehicles - Nozzle, test requirements and dimensions C 13821:2002 Potentially explosive atmospheres - Explosion prevention and protection - Determination of minimum ignition energy of dust/air mixtures

6 C 183/4 Official Journal of the European Union superseded C 13980:2002 Potentially explosive atmospheres - Application of quality systems C :2004 Determination of explosion characteristics of dust clouds - Part 1: Determination of the maximum explosion pressure pmax of dust clouds C :2006 Determination of explosion characteristics of dust clouds - Part 2: Determination of the maximum rate of explosion pressure rise (dp/dt)max of dust clouds C :2006 Determination of explosion characteristics of dust clouds - Part 3: Determination of the lower explosion limit LEL of dust clouds C :2004 Determination of explosion characteristics of dust clouds - Part 4: Determination of the limiting oxygen concentration LOC of dust clouds C 14373:2005 Explosion suppression systems C 14460:2006 Explosion resistant equipment C 14491:2006 Dust explosion venting protective systems :2006/AC:2008 C :2006+A1:2009 Cranes - Power driven winches and hoists - Part 1: Power driven winches :2006 ( ) :2006+A1:2009/AC:2010 C :2006+A1:2009 Cranes - Power driven winches and hoists - Part 2: Power driven hoists :2006 ( ) :2006+A1:2009/AC:2010 C 14522:2005 Determination of the auto ignition temperature of gases and vapours C :2004 Explosion prevention and protection in underground mines - Protective systems - Part 1: 2-bar explosion proof ventilation structure :2004/AC:2006

7 Official Journal of the European Union C 183/5 superseded C :2007 Explosion prevention and protection in underground mines - Protective systems - Part 2: Passive water trough barriers :2007/AC:2008 C :2007 Explosion prevention and protection in underground mines - Protective systems - Part 4: Automatic extinguishing systems for road headers :2007/AC:2008 C 14677:2008 Safety of machinery - Secondary steelmaking - Machinery and equipment for treatment of liquid steel C :2006+A1:2009 LPG equipment and accessories - Construction and performance of LPG equipment for automotive filling stations - Part 1: Dispensers :2006 ( ) C 14681:2006 Safety of machinery - Safety requirements for machinery and equipment for production of steel by electric arc furnaces C 14756:2006 Determination of the limiting oxygen concentration (LOC) for flammable gases and vapours C 14797:2006 Explosion venting devices C 14973:2006+A1:2008 Conveyor belts for use in underground installations - Electrical and flammability safety requirements 14973:2006 The date of this C 14983:2007 Explosion prevention and protection in underground mines - Equipment and protective systems for firedamp drainage C 14986:2007 Design of fans working in potentially explosive atmospheres C 14994:2007 Gas explosion venting protective systems C 15089:2009 Explosion isolation systems C 15188:2007 Determination of the spontaneous ignition behaviour of dust accumulations

8 C 183/6 Official Journal of the European Union superseded C 15198:2007 Methodology for the risk assessment of non-electrical equipment and components for intended use in potentially explosive atmospheres C 15233:2007 Methodology for functional safety assessment of protective systems for potentially explosive atmospheres C 15268:2008 Petrol filling stations - Safety requirements for the construction of submersible pump assemblies C 15794:2009 Determination of explosion points of flammable liquids Cenelec 50050:2006 Electrical apparatus for potentially explosive atmospheres - Electrostatic hand-held spraying equipment Cenelec 50104:2002 Electrical apparatus for the detection and measurement of oxygen - Performance requirements and test methods :1998 ( ) 50104:2002/A1: Note 3 ( ) Cenelec 50176:2009 Stationary electrostatic application equipment for ignitable liquid coating material - Safety requirements Cenelec 50177:2009 Stationary electrostatic application equipment for ignitable coating powders - Safety requirements Cenelec :1999 Specification for open path apparatus for the detection of combustible or toxic gases and vapours Part 1: General requirements and test methods :1999/A1: Note 3 ( ) Cenelec :1999 Specification for open path apparatus for the detection of combustible or toxic gases and vapours Part 2: Performance requirements for apparatus for the detection of combustible gases Cenelec :1998 Electrical apparatus for use in the presence of combustible dust Part 2-1: Test methods - Methods for determining the minimum ignition temperatures of dust Cenelec 50303:2000 Group I, Category M1 equipment intended to remain functional in atmospheres endangered by firedamp and/ or coal dust

9 Official Journal of the European Union C 183/7 superseded Cenelec 50381:2004 Transportable ventilated rooms with or without an internal source of release :2004/AC:2005 Cenelec :2009 Explosive atmospheres Part 0: Equipment - General requirements IEC :2007 Cenelec :2007 Explosive atmospheres - Part 1: Equipment protection by flameproof enclosures d IEC :2007 Cenelec :2007 Explosive atmospheres Part 2: Equipment protection by pressurized enclosure p IEC :2007 Cenelec :2007 Explosive atmospheres Part 5: Equipment protection by powder filling q IEC :2007 Cenelec :2007 Explosive atmospheres Part 6: Equipment protection by oil immersion o IEC :2007 Cenelec :2007 Explosive atmospheres Part 7: Equipment protection by increased safety e IEC :2006 Cenelec :2007 Explosive atmospheres Part 11: Equipment protection by intrinsic safety i IEC :2006 Cenelec :2005 Electrical apparatus for explosive gas atmospheres Part 15: Construction, test and marking of type of protection n electrical apparatus IEC : : : : : : : : : : ( ) ( ) ( ) ( ) ( ) Cenelec :2009 Explosive atmospheres Part 18: Equipment protection by encapsulation m : : IEC :2009 Cenelec : Electrical apparatus for explosive gas atmospheres Part 25: Intrinsically safe systems IEC :2003

10 C 183/8 Official Journal of the European Union superseded Cenelec :2007 Explosive atmospheres Part 26: Equipment with equipment protection level (EPL) Ga IEC :2006 Cenelec :2008 Explosive atmospheres Part 27: Fieldbus intrinsically safe concept (FISCO) IEC :2008 Cenelec :2007 Explosive atmospheres Part 28: Protection of equipment and transmission systems using optical radiation IEC :2006 Cenelec :2007 Explosive atmospheres Part 29-1: Gas detectors - Performance requirements of detectors for flammable gases IEC :2007 (Modified) Cenelec :2007 Explosive atmospheres Part 30-1: Electrical resistance trace heating - General and testing requirements IEC : : :2000 and its amendment : : : : Cenelec :2009 Explosive atmospheres Part 31: Equipment dust ignition protection by enclosure t : IEC :2008 Cenelec : Electrical apparatus for use in the presence of combustible dust Part 4: Type of protection pd IEC :2001 Cenelec : Electrical apparatus for use in the presence of combustible dust Part 11: Protection by intrinsic safety id IEC :2005 Cenelec :2006 Caplights for use in mines susceptible to firedamp Part 1: General requirements - Construction and testing in relation to the risk of explosion IEC : :2002 ( ) ( 1 ) ESO: European Standards Organisation: C: Avenue Marnix 17, 1000 Brussels, BELGIUM, Tel ; fax ( CELEC: Avenue Marnix 17, 1000 Brussels, BELGIUM, Tel ; fax ( ETSI: 650, route des Lucioles, Sophia Antipolis, FRANCE, Tel ; fax , (

11 Official Journal of the European Union C 183/9 : Generally the date of cessation of conformity will be the date of withdrawal ( dow ), set by the European Standardisation Organisation, but attention of users of these s is drawn to the fact that in certain exceptional cases this can be otherwise. : The new (or amended) has the same scope as the superseded. On the date stated, the superseded ceases to give conformity with the essential requirements of the directive. Note 2.2: The new has a broader scope than the superseded. On the date stated the superseded ceases to give conformity with the essential requirements of the directive. Note 2.3: The new has a narrower scope than the superseded. On the date stated the (partially) superseded ceases to give conformity with the essential requirements of the directive for those products that fall within the scope of the new. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded, but that do not fall within the scope of the new, is unaffected. Note 3: In case of amendments, the referenced is CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded (column 3) therefore consists of CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded ceases to give conformity with the essential requirements of the directive. NOTE: Any information concerning the availability of the s can be obtained either from the European Standardisation Organisations or from the national isation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council ( 1 ) amended by the Directive 98/48/EC ( 2 ). Harmonised s are adopted by the European Standardisation Organisations in English (C and CELEC also publish in French and German). Subsequently, the titles of the harmonised s are translated into all other required official languages of the European Union by the National Standards Bodies. The European Commission is not responsible for the correctness of the titles which have been presented for in the Official Journal. Publication of the references in the Official Journal of the European Union does not imply that the s are available in all the Community languages. This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. More information about harmonised s on the Internet at ( 1 ) OJ L 204, , p. 37. ( 2 ) OJ L 217, , p. 18.

12 C 183/10 Official Journal of the European Union Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (Text with EEA relevance) (Publication of titles and references of harmonised s under the directive) (2010/C 183/02) superseded C 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices : A1:1998 ( ) 556-1:2001/AC: C 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices C 980:2008 Symbols for use in the labelling of medical devices :2003 ( ) C 1041:2008 Information supplied by the manufacturer of medical devices : C ISO :2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO :2009) ISO :2009 C ISO :2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO :2002, including Amd 1:2006) ISO :2002 C ISO :2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO :2009) ISO :1999 ( ) C ISO :2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO :2007) ISO :2007 C ISO :2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO :2008) ISO :2008/AC:2009

13 Official Journal of the European Union C 183/11 superseded C ISO :2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO :2009) C ISO :2009 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO :2002, including Amd 1:2006) C ISO :2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO :2006) C ISO :2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO :2007) C ISO :2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO :1998) ISO : ISO : ISO : ISO : ISO :1998 C ISO :2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO :2010) ISO : C ISO :2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO :2002) C ISO :2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO :2005) C ISO :2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO :2007) C ISO :2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO :2006) C ISO :2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO :2006, corrected version ) ISO : ISO : : : ( ) ( ) ISO :2007/AC:

14 C 183/12 Official Journal of the European Union superseded C ISO :2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO :2006) C ISO :2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO :2006) C ISO :2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO :2005) C ISO :2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO :2006) C ISO :2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO :2006) ISO : ISO : ISO : ISO : : : :1996 ( ) ISO :2006/AC: C ISO :2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO :2009) C ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) ISO 13485:2003/AC:2009 C 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements ISO 13488:2000 ISO 13485: ( ) C ISO :2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO :2003) ISO :2003 C ISO :2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO :2003) ISO :2003 C ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) ISO 14937:2000

15 Official Journal of the European Union C 183/13 superseded C ISO 14971:2009 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version ) ISO 14971:2007 C ISO :2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO :2006) C :1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer C :2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) C :2010 Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems Cenelec :1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer (*) Cenelec :2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) (*) Cenelec :2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) (*) Cenelec :1990 Medical electrical equipment - Part 1: General requirements for safety IEC : : ( ) :1990/A1:1993 IEC :1988/A1: :1990/A2:1995 IEC :1988/A2:1995 (*) Note 3 The date of this Note 3 The date of this Cenelec :2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC :2005 (*) :1990 and its amendments

16 C 183/14 Official Journal of the European Union superseded Cenelec 62304:2006 Medical device software - Software life-cycle processes IEC 62304:2006 (*) ( 1 ) ESO: European Standards Organisation: C: Avenue Marnix 17, 1000, Brussels, BELGIUM, Tel ; fax ( CELEC: Avenue Marnix 17, 1000, Brussels, BELGIUM, Tel ; fax ( ETSI: 650, route des Lucioles, Sophia Antipolis, FRANCE, Tel ; fax , ( (*) This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. : Generally the date of cessation of conformity will be the date of withdrawal ( dow ), set by the European Standardisation Organisation, but attention of users of these s is drawn to the fact that in certain exceptional cases this can be otherwise. : The new (or amended) has the same scope as the superseded. On the date stated, the superseded ceases to give conformity with the essential requirements of the directive. Note 2.2: The new has a broader scope than the superseded. On the date stated the superseded ceases to give conformity with the essential requirements of the directive. Note 2.3: The new has a narrower scope than the superseded. On the date stated the (partially) superseded ceases to give conformity with the essential requirements of the directive for those products that fall within the scope of the new. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded, but that do not fall within the scope of the new, is unaffected. Note 3: In case of amendments, the referenced is CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded (column 3) therefore consists of CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded ceases to give conformity with the essential requirements of the directive. NOTE: Any information concerning the availability of the s can be obtained either from the European Standardisation Organisations or from the national isation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council ( 1 ) amended by the Directive 98/48/EC ( 2 ). Harmonised s are adopted by the European Standardisation Organisations in English (C and CELEC also publish in French and German). Subsequently, the titles of the harmonised s are translated into all other required official languages of the European Union by the National Standards Bodies. The European Commission is not responsible for the correctness of the titles which have been presented for in the Official Journal. Publication of the references in the Official Journal of the European Union does not imply that the s are available in all the Community languages. This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. More information about harmonised s on the Internet at ( 1 ) OJ L 204, , p. 37 ( 2 ) OJ L 217, , p. 18

17 Official Journal of the European Union C 183/15 Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Text with EEA relevance) (Publication of titles and references of harmonised s under the directive) (2010/C 183/03) superseded C 285:2006+A2:2009 Sterilization - Steam sterilizers - Large sterilizers :2006+A1:2008 C 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes :1993 ( ) C 455-2:2009 Medical gloves for single use - Part 2: Requirements and testing for physical properties 455-2:2000 ( ) C 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation :1999 ( ) C 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination C 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices : A1:1998 ( ) 556-1:2001/AC: C 556-2:2003 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices C 794-1:1997+A2:2009 Lung ventilators - Part 1: Particular requirements for critical care ventilators :1997 C 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators 794-3:1998 C 980:2008 Symbols for use in the labelling of medical devices :2003 ( ) C 1041:2008 Information supplied by the manufacturer of medical devices :

18 C 183/16 Official Journal of the European Union superseded C :1995+A2:2009 Non-invasive sphygmomanometers - Part 1: General requirements C :1995+A1:2009 Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers :1995 ( ) C :1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems :1997 ( ) C :2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers C :2004 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding :1997 ( ) C :2005+A1:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO :2001, modified) :2005 C 1422:1997+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods :1997 C 1618: Catheters other than intravascular catheters - Test methods for common properties C 1639:2009 Dentistry - Medical devices for dentistry - Instruments 1639:2004 ( ) C 1640:2009 Dentistry - Medical devices for dentistry Equipment 1640:2004 ( ) C 1641:2009 Dentistry - Medical devices for dentistry - Materials 1641:2004 ( ) C 1642:2009 Dentistry - Medical devices for dentistry - Dental implants 1642:2004 ( ) C 1707: Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings C 1782:1998+A1:2009 Tracheal tubes and connectors 1782:1998

19 Official Journal of the European Union C 183/17 superseded C 1789:2007 Medical vehicles and their equipment - Road ambulances :1999 ( ) This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. C 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified) 1820:2005 C 1865:1999 Specifications for stretchers and other patient handling equipment used in road ambulances C 1970:2000 Adjustable beds for disabled persons - Requirements and test methods :2000/A1: Note 3 ( ) C 1985:1998 Walking aids - General requirements and test methods This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. C ISO :2008 Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO :2008) C ISO :2007 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO :2006) C ISO 4074:2002 Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) :1996 ( ) ISO 4074:2002/AC: C ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) C ISO :2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO :2004) C ISO :2007 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO :2006) ISO 4135: : :1995 ( ) ( ) ( )

20 C 183/18 Official Journal of the European Union superseded C ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) :1998 ( ) C ISO 5360:2009 Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006) ISO 5360:2007 C ISO :2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO :2000) ISO :2004 C ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) ISO 5840:2005 C ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) ISO 7197:2006 C ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) ISO 7376:2009 C ISO :2007 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO :2007) :1998 ( ) ISO :2007/A1:2010 Note ISO :2007/A2:2010 Note C ISO :2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO :2007) :1998 ( ) C ISO 7439:2009 Copper-bearing intra-uterine contraceptive devices - Requirements, tests (ISO 7439:2002) ISO 7439:2002 C ISO :2009 Sterile hypodermic syringes for single use - Part 3: Autodisable syringes for fixed-dose immunization (ISO :2005) ISO :2005 C ISO :2009 Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO :2006) ISO :2006

21 Official Journal of the European Union C 183/19 superseded C ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) ISO 8185:2007 C ISO 8359:2009 Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996) ISO 8359:1996 C ISO :2007 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO :2007) C ISO :2009 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO :2007) ISO :2007 C ISO :2009 Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO :2007) ISO :2007 C ISO :2009 Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO :2004) ISO :2004 C ISO :2009 Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO :2004) ISO :2004 C ISO :2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO :2008) : C ISO :2008 Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO :2008) : C ISO :2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO :2000) ISO :2000 C ISO :2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO :2001) ISO :2002

22 C 183/20 Official Journal of the European Union superseded C ISO 9713:2009 Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) C ISO 9919:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) C ISO :2009 Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO :1999) C ISO :2009 Medical suction equipment - Part 2: Manually powered suction equipment (ISO :1999) C ISO :2009 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO :1999) C ISO 10328:2006 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006) ISO 9713: ISO 9919: ISO : ISO : ISO : This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. C ISO :2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flowmetering devices (ISO :2006) C ISO :2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO :2005) C ISO :2006 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO :2005) C ISO :2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO :2008) C ISO 10535:2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) : : : : ISO 10535:1998 ( ) ( ) ( ) ( ) ( ) This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.

23 Official Journal of the European Union C 183/21 superseded C ISO :2009 Sterile, single-use intravascular catheters - Part 1: General requirements (ISO :1995, including Amd 1:1999 and Amd 2:2004) ISO :1996 C ISO :2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO :2004) ISO :2004 C ISO :2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO :2002) ISO :2002 C ISO :2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO :2004) ISO :2004 C ISO :2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO :2009) ISO :2009 C ISO :2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO :2003) ISO :2003 C ISO :2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO :2002, including Amd 1:2006) ISO :2002 C ISO :2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO :2009) ISO :1999 ( ) C ISO :2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO :2007) ISO :2007 C ISO :2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO :2008) ISO :2008/AC:2009 C ISO :2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO :2009) ISO :2009

24 C 183/22 Official Journal of the European Union superseded C ISO :2009 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO :2002, including Amd 1:2006) ISO :2002 C ISO :2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO :2006) ISO :2006 C ISO :2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO :2007) ISO :2007 C ISO :2009 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO :1998) ISO :1998 C ISO :2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO :2001) ISO :2001 C ISO :2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO :2000) ISO :2000 C ISO :2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO :2010) ISO : C ISO :2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO :2002) ISO :2002 C ISO :2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO :2005) ISO :2005 C ISO :2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO :2007) :1994 ( ) C ISO :2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO :2006) :1994 ( )

25 Official Journal of the European Union C 183/23 superseded C ISO :2007 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO :2006, corrected version ) ISO :2007/AC: C ISO :2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO :2006) ISO :2006 C ISO :2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO :2006) ISO :2006 C ISO :2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO :2005) ISO :2005 C ISO :2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO :2007, including Cor 1:2007) ISO :2007 C ISO 11197:2009 Medical supply units (ISO 11197:2004) ISO 11197:2004 C ISO :2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO :2006) ISO :2006 C ISO :2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO :2006) C ISO :2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO :2006) : : :1996 ( ) ISO :2006/AC: C ISO :2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO :2009)

26 C 183/24 Official Journal of the European Union superseded C ISO :2009 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO :2005) C ISO :2009 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO :2007) C ISO :2009 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO :2006) C ISO 11990:2003 Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) ISO : ISO : ISO 11990:1999 ( ) C :1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits :1998 C :1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices :1998 C 12182:1999 Technical aids for disabled persons - General requirements and test methods This still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended will be published by C as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered. C 12183:2009 Manual wheelchairs - Requirements and test methods C 12184:2009 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods C 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators 12342:1998 C :2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device :2000 C :2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers :2000