Nederlandse Ontwerp norm NEN-EN 13060 Small steam sterilizers Publicatie uitsluitend voor commentaar Commentaar vóór 2012-09-30 Zal vervangen NEN-EN 13060:2004+A2:2010 juni 2012 ICS 11.080.10 Als Europees normontwerp is gepubliceerd: pren 13060:2012,IDT Dit document mag slechts op een stand-alone PC worden geinstalleerd. Gebruik op een netwerk is alleen. toestaan als een aanvullende licentieovereenkomst voor netwerkgebruik met NEN is afgesloten. This document may only be used on a stand-alone PC. Use in a network is only permitted when a supplementary license agreement for us in a network with NEN has been concluded. Definitief vastgestelde normen zullen als Nederlandse norm gelden. Daarom wordt dit normontwerp in Nederland voor commentaar gepubliceerd. Op het ontwerp ingebracht commentaar zal aan de bevoegde normcommissie worden voorgelegd die hiermee rekening zal houden bij de bepaling van de Nederlandse stem. Indien er geen bezwaar bij NEN wordt gebracht, kan dat leiden tot ongewijzigde definitieve vaststelling van het ontwerp als norm. Van Europese normen bestaan drie officiële versies: Engels, Frans en Duits. Voor Nederland zal de Engelse versie gelden. Daarnaast kan er gekozen worden voor een andere geautoriseerde versie in het Nederlands. Normcommissie 301081 "Steriliteit" THIS PUBLICATION IS COPYRIGHT PROTECTED DEZE PUBLICATIE IS AUTEURSRECHTELIJK BESCHERMD Apart from exceptions provided by the law, nothing from this publication may be duplicated and/or published by means of photocopy, microfilm, storage in computer files or otherwise, which also applies to full or partial processing, without the written consent of the Netherlands Standardization Institute. The Netherlands Standardization Institute shall, with the exclusion of any other beneficiary, collect payments owed by third parties for duplication and/or act in and out of law, where this authority is not transferred or falls by right to the Reproduction Rights Foundation. Auteursrecht voorbehouden. Behoudens uitzondering door de wet gesteld mag zonder schriftelijke toestemming van het Nederlands Normalisatie-instituut niets uit deze uitgave worden verveelvoudigd en/of openbaar gemaakt door middel van fotokopie, microfilm, opslag in computerbestanden of anderszins, hetgeen ook van toepassing is op gehele of gedeeltelijke bewerking. Het Nederlands Normalisatie-instituut is met uitsluiting van ieder ander gerechtigd de door derden verschuldigde vergoedingen voor verveelvoudiging te innen en/of daartoe in en buiten rechte op te treden, voor zover deze bevoegdheid niet is overgedragen c.q. rechtens toekomt aan de Stichting Reprorecht. Although the utmost care has been taken with this publication, errors and omissions cannot be entirely excluded. The Netherlands Standardization Institute and/or the members of the committees therefore accept no liability, not even for direct or indirect damage, occurring due to or in relation with the application of publications issued by the Netherlands Standardization Institute. Hoewel bij deze uitgave de uiterste zorg is nagestreefd, kunnen fouten en onvolledigheden niet geheel worden uitgesloten. Het Nederlands Normalisatie-instituut en/of de leden van de commissies aanvaarden derhalve geen enkele aansprakelijkheid, ook niet voor directe of indirecte schade, ontstaan door of verband houdend met toepassing van door het Nederlands Normalisatie-instituut gepubliceerde uitgaven. 2012 Nederlands Normalisatie-instituut Postbus 5059, 2600 GB Delft Telefoon (015) 2 690 390, Fax (015) 2 690 190
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM ICS 11.080.10 NEN-EN 13060:2012 Ontw. English Version DRAFT pren 13060 rev May 2012 Small steam sterilizers Will supersede EN 13060:2004+A2:2010 Petits stérilisateurs à la vapeur d'eau Dampf-Klein-Sterilisatoren This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 102. If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. pren 13060 rev:2012: E
pren 13060:2012 (E) NEN-EN 13060:2012 Ontw. Contents Page Foreword...4 Introduction...6 1 Scope...8 2 Normative references...8 3 Terms and definitions...9 4 General technical requirements... 16 4.1 Dimensions... 16 4.2 Materials... 16 4.3 Design and construction... 16 4.4 Instrumentation, indication and registration devices... 18 4.5 Control systems... 27 4.6 Process... 28 4.7 Services and local environment... 29 4.8 Information to be provided... 30 4.9 Marking... 34 4.10 Accessories... 35 5 Performance requirements... 35 5.1 General... 35 5.2 Air leakage rate... 35 5.3 Attainment of the sterilization conditions... 35 5.4 Product compatibility... 36 5.5 Drying... 36 5.6 Microbicidal efficacy... 36 5.7 Non-condensable gases... 36 6 Safety, risk control and usability... 36 6.1 General requirements... 36 6.2 Requirements for EMC... 37 6.3 Requirements for pressure equipment... 37 6.4 Requirements for risk control... 37 7 Categories of tests... 38 7.1 General... 38 7.2 Type tests... 38 7.3 Works test... 39 7.4 Installation tests... 39 8 Test equipment... 40 8.1 General... 40 8.2 Temperature sensors... 40 8.3 Thermometric recording instrument... 40 8.4 Pressure measurement and recording instrument... 41 8.5 Test equipment for the performance of the air leakage test... 42 8.6 Porous load... 43 8.7 Solid load, unwrapped... 44 8.8 Solid load, single wrapped... 45 8.9 Solid load, double wrapped... 45 8.10 Process challenge device (PCD) and chemical indicator system for narrow lumen... 45 8.11 Process challenge device and chemical indicator system for simple hollow item... 45 8.12 Balance for load dryness test... 46 2
NEN-EN 13060:2012 Ontw. pren 13060:2012 (E) 9 Test programme... 46 10 Test methods... 48 10.1 General requirements on technical tests... 48 10.2 Air leakage test... 49 10.3 Dynamic sterilizer chamber pressure test... 50 10.4 Empty chamber test... 50 10.5 Solid load test... 51 10.6 Narrow lumen test... 51 10.7 Simple hollow item test... 52 10.8 Small porous load test... 53 10.9 Full porous load test (single and double wrapped)... 54 10.10 Small porous items test (single and double wrapped)... 54 10.11 Solid load dryness test... 55 10.12 Porous load dryness test (small and full, single and double wrapped)... 56 10.13 Small porous items dryness test (single and double wrapped)... 57 10.14 Non-condensable gases test... 57 10.15 Microbiological test for solid loads... 61 10.16 Microbiological test for narrow lumens... 61 10.17 Microbiological test for simple hollow item... 61 10.18 Microbiological test for small porous loads... 62 10.19 Microbiological test for full porous loads... 62 10.20 Microbiological test for small porous items... 63 Annex A (informative) Clarification of the definition of narrow lumens and simple hollow items (see 3.10 and 3.11)... 64 Annex B (informative) Process evaluation system... 66 Annex C (informative) Suggested maximum limits of contaminants in and specification for water for steam sterilization... 67 Annex D (informative) Example of a table to be supplied with pre-purchase documentation and with the instructions for use... 68 Annex E (informative) Load support systems... 69 Annex F (informative) Rationale for the tests... 70 F.1 Air leakage test... 70 F.2 Dynamic sterilizer chamber pressure test... 70 F.3 Empty chamber test... 70 F.4 Small porous load test... 70 F.5 Full porous load test... 70 F.6 Solid load test... 70 F.7 Small porous items... 70 F.8 Narrow lumen test... 71 F.9 Simple hollow item test... 71 F.10 Solid load dryness test... 71 F.11 Porous load dryness test... 71 F.12 Non-condensable gases test... 71 F.13 Microbiological test for small porous loads... 71 F.14 Microbiological test for full porous loads... 71 F.15 Microbiological test for small porous items... 71 Annex G (informative)... 73 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices... 74 Bibliography... 78 3
pren 13060:2012 (E) NEN-EN 13060:2012 Ontw. Foreword This document (pren 13060:2012) has been prepared by Technical Committee CEN/TC 102 Sterilizers for medical purposes, the secretariat of which is held by DIN. This document is currently submitted to the CEN Enquiry. This document will supersede EN 13060:2004+A2:2010. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. The main changes with respect to the previous edition are listed below: Update of Normative references Update of Terms and definitions (certain definitions no longer referenced in the standard have been erased) Addition of Clause 4.3.1 (General requirements for design and construction) Addition of Clause 4.3.5 (Vibrations) Addition of Clause 4.3.6 (Noise) Addition of Clause 4.5.4 (Software) Deletion of Clause 4.7. (Electromagnetic compatibility) Modifications to Clause 4.8: Clause 4.8 in EN 13060:2004 + A2:2010 (Marking and accompanying documents) was divided into two separate clause in PR EN 13060: Clause 4.8 (Information to be provided) and Clause 4.9 (Marking) Modifications to Clause 5.3 Modifications to Clause 6 notably addition of requirements for EMC, pressure equipment and risk control Addition of Clause 7.2.6 (Sound power level) Modifications to Clause 8.6.1 (relative humidity required in point e) Deletion of Clause 8.6.2.2 (Reduced test pack) Deletion of Clause 8.6.3.2 Modifications to Clause 8.10 Modifications to Annex A to include both the definition for narrow lumens and for simple hollow items Addition of informative Annex G (Example of a PCD for narrow lumen) 4
NEN-EN 13060:2012 Ontw. pren 13060:2012 (E) Modifications to Annex ZA.1 relating to the "Medical Devices" Directive 93/42/EC (and modifying texts) Modifications to Annex ZA.2 relating to the "Machinery" Directive 2006/42/EC (and modifying texts) Limited modifications have also been made to the following sections in order to clarify: Introduction, scope 4.4.3.3 (erased normative reference to EN 475) Modifications to Clauses 7.1, 7.2.1, 7.3.1, 7.3.2, 7.4.1, 8.1, 8.11 for clarification Updated Bibliography 5
pren 13060:2012 (E) NEN-EN 13060:2012 Ontw. Introduction Small steam sterilizers are widely used for medical purposes, e.g. in general medical practice, dentistry, facilities for personal hygiene and beauty care and also veterinary practice. They are also used for materials and equipment which are likely to come into contact with blood or bodily fluids, e.g. implements used by beauty therapists, tattooists, body piercers and hairdressers. The specific nature of such sterilizer loads used within these fields of application call for different performance requirements for the sterilization cycles and hence different corresponding test methods. This European Standard specifies the general requirements for small steam sterilizers and associated test methods. Performance is defined by reference to standard test loads. These are used to define a basic minimum performance and are not necessarily related to specific medical devices. It is the responsibility of the user and the manufacturer of the device to be sterilized to determine that any particular process cycle is suitable for sterilizing a particular device. Test loads are: narrow lumen (formerly hollow loads A); simple hollow item (formerly hollow loads B); standard test pack for porous loads (wrapped); small porous items (wrapped); composition of metal bolts (wrapped or unwrapped). These test loads are intended in general to represent kinds of real products having characteristics such as those of: solid products; hinged devices; porous loads; small porous items; lumen devices; bowls and receivers; unwrapped products; and wrapped products. NOTE For wrapped products, single-layer or multiple-layer packaging systems should provide a sterile barrier system which conforms to EN ISO 11607-1. The performance tests specified in this standard can also be used by the manufacturer of the device to be sterilized to specify the appropriate performance for decontamination processes according to the requirements for information to be given by medical device manufacturers according to EN ISO 17664:2004. This will enable users to identify the specific sterilizer performance required to safely process their devices. 6
NEN-EN 13060:2012 Ontw. pren 13060:2012 (E) The performance requirements specified in this document are not intended for the process to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. However, some national regulations require the use of modified steam processes as part of a general prion decontamination programme. It is essential that the sterilizer and associated equipment is used only for the sterilization of the type of products for which it is designed. The choice of sterilizer, sterilization cycle or quality of services provided can be inappropriate for a particular load. Therefore the suitability of a sterilization procedure for a particular product needs to be verified by validation (see EN ISO 17665-1). 7
pren 13060:2012 (E) NEN-EN 13060:2012 Ontw. 1 Scope This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 litres and unable to accommodate a sterilization module (300 mm 300 mm 600 mm). The requirements concerning the quality management and risk management are addressed by normative reference to other standards (e.g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1, clauses 9 and 10 which are applicable to processes conducted by small steam sterilizers. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide). 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 285 + A2:2009, Sterilization Steam sterilizers Large sterilizers. EN ISO 11138-3:2009, Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006). EN ISO 11140-1:2009, Sterilization of health care products Chemical indicators Part 1: General requirement (ISO 11140-1:2005). EN 867-5:2001, Non-biological systems for use in sterilizers Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S. EN 868:2009 (parts 2-10), Packaging for terminally sterilized medical devices 1. EN 10088-1:2005, Stainless steels Part 1: List of stainless steels. 1 EN 868-1 has been replaced by EN ISO 11607-1. 8
NEN-EN 13060:2012 Ontw. pren 13060:2012 (E) EN ISO 14971:2009, Medical devices Application of risk management to medical devices. EN 60529:1992, Degrees of protection provided by enclosures (IP code). EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements. EN 61010-2-040:2005, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials. EN 61326-1:2006, Electrical equipment for measurement, control and laboratory use EMC requirements General requirements (IEC 61326-1:2005). EN ISO 228-1:2003, Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation (ISO 228-1:2000). EN 1041:2008, Information supplied by the manufacturer of medical devices. EN ISO 3746:2010, Acoustics Determination of sound power levels of noise sources using sound pressure Survey method using and enveloping measurement surface over a reflecting plane (ISO 3746:2010). EN ISO 4017:2001, Hexagon head screws Product grades A and B (ISO 4017:1999). EN ISO 4126-1:2004, Safety devices for protection against excessive pressure Part 1: Safety valves (ISO 4126-1:2004). EN ISO 13485:2003, Medical devices Quality management systems Requirements for regulatory purposes (ISO 13485:2003). EN 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). EN ISO 17665-1:2006, 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 17665-1:2006). EN 13445:2009 (all parts), Unfired pressure vessels. EN ISO 11607-1:2009, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006). 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 active drain of small steam sterilizers drain through which fluids present in the chamber are discharged during the process 3.2 automatic controller <sterilization> device that, in response to pre-determined operating cycle variables, operates the sterilizer sequentially through the required stages of the cycle(s) [SOURCE: EN ISO 17665-1:2006, 3.2] 9
pren 13060:2012 (E) NEN-EN 13060:2012 Ontw. 3.3 calibration set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realised by standards 3.4 double ended sterilizer sterilizer in which there is a door at each end of the sterilizer chamber [SOURCE:EN 285: 2006, 3.11] 3.5 equilibration time period which elapses between the attainment of the sterilization temperature in the sterilizer chamber and the attainment of the sterilization temperature at all points within the load [SOURCE:EN ISO 17665-1:2006, 3.13] 3.6 fault one or more of the process parameters lying outside its/their specified tolerance(s) [SOURCE:ISO/TS 11139:2006, 2.19] 3.7 hazard potential source of harm [SOURCE: ISO/IEC Guide 51:1999, 3.5] 3.8 hazardous situation circumstance in which people, property or the environment are exposed to one or more hazard(s) [SOURCE: ISO/IEC Guide 51:1999, 3.6] 3.9 holding time (small steam sterilizers) period for which the temperature of all points within the usable space including the temperature measurement reference position is held within the sterilization temperature band Note 1 to entry: The holding time follows immediately after the equilibration time. The extent of the holding time is related to the sterilization temperature. 3.10 installation test series of checks and tests performed after installation of the sterilizer in the place of use 3.11 instructions for use instructions intended for the user (operator) of the sterilizer to enable safe and appropriate use 3.12 locked (with respect to the door) with the locking device(s) fully engaged 10
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