EN 285-2006 6250 Sterilization - Steam sterilizers - Large sterilizers (Incorporates Amendment A2 2009)《消毒 蒸气消毒 大型消毒设备 包含修改件A2-2009》.pdf

1、BRITISH STANDARDBS EN 285:2006 +A2:2009Sterilization Steam sterilizers Large sterilizersICS 11.080.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g5

2、8Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-National forewordThis British Standard is the UK implementation of EN 285:2006+A2:2009. It supersedes BS EN 285:2006+A1:2008 whic

3、h is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, text altered by CEN amendment A1 is indicated by !“.The UK participation in its preparation was ent

4、rusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its corr

5、ect application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN 285:2006+A2:2009This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2010Amendments/corrigenda issued since publicationDate Com

6、ments 30 June 2008 Implementation of CEN amendment A1:200831 January 2010 Implementation of CEN amendment A2:2009ISBN 978 0 580 65145 8Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS

7、EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 285:2006+A2 May 2009 ICS 11.080.10 Supersedes EN 285:2006+A1:2008English Version Sterilization - Steam sterilizers - Large sterilizers Strilisation - Strilisateurs la vapeur deau - Grands strilisateurs Sterilisation - Dampf-Sterilisatoren - G

8、ro-Sterilisatoren This European Standard was approved by CEN on 27 April 2006 and includes Amendment 1 approved by CEN on 4 February 2008 and Amendment 2 approved by CEN on 5 April 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givi

9、ng this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official ver

10、sions (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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgiu

11、m, Bulgaria, 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 and United Kingdom. EUROPEAN COMMITTEE FOR S

12、TANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 285:2006+A2:2009: ECopyright European Committee

13、for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN 285:2006+A2:2009 (E) 2 Contents Page Foreword 41 Scope 52 Normative references 53 Terms and definitions . 64 Mechanical components . 115 Process components

14、146 Instrumentation, indicating and recording devices . 157 Control systems . 228 Performance requirements . 239 Sound power 2610 Rate of pressure change . 2611 Safety 2712 Marking . 2713 Service and local environment . 2714 Testing 2915 !Hollow load test“ . 3116 Thermometric tests 3217 Bowie and Di

15、ck test . 3618 Air leakage test 3719 Air detector tests . 3820 Load dryness tests 4121 Sound power test . 4422 Steam quality tests 4523 Dynamic sterilizer chamber pressure test 5524 Test apparatus, equipment and material . 5625 Documentation to be supplied by the manufacturer . 6326 Information to b

16、e supplied by the manufacturer 64Annex A (informative) Environmental aspects . 67Annex B (informative) Steam supply; suggested maximum values of contaminants in feed water and condensate . 72Annex C (informative) Recommended materials 73Annex D (informative) Temperature and time tolerances during th

17、e small load thermometric test. 76Annex E (informative) Guidance for installation and operational qualification tests to be included in the instructions for use supplied with a sterilizer 77Annex F (informative) Criteria for identifying sterilizers as the same type . 79Annex ZA (informative) Relatio

18、nship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 80BS EN 285:2006+A2:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from

19、 IHS-,-,-EN 285:2006+A2:2009 (E) 3 Bibliography 85BS EN 285:2006+A2:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN 285:2006+A2:2009 (E) 4 Foreword This document (EN 285:2

20、006+A2:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by Novemb

21、er 2009 and conflicting national standards shall be withdrawn at the latest by March 2010. This document includes Amendment 1, approved by CEN on 2008-02-04 and Amendment 2, approved by CEN on 2009-04-05. This document supersedes #EN 285:2006+A1:2008$. The start and finish of text introduced or alte

22、red by amendment is indicated in the text by tags ! “ and # $. 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(s). For relationship with EU Directive(s), see informati

23、ve Annex ZA, which is an integral part of this document. This document does not specify requirements for the validation and routine control of sterilization by moist heat. A European Standard specifying requirements for the validation and routine control of sterilization by moist heat was prepared b

24、y CEN/TC 204 “Sterilization of medical devices“, see EN 554 (currently under revision, see prEN ISO 17665). 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, bo

25、vine spongiform encephalopathy and Creutzfeld-Jakob disease. However, some national regulations require the use of modified steam processes as part of a general prion decontamination programme. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following c

26、ountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,

27、Spain, Sweden, Switzerland and United Kingdom. BS EN 285:2006+A2:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN 285:2006+A2:2009 (E) 5 1 Scope 1.1 This European Standard

28、specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majo

29、rity of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. Large steam sterili

30、zers can also be used during the commercial production of medical devices. 1.2 This European Standard is not applicable to steam sterilizers designed to process a size of load less than one sterilization module or having a chamber volume less than 60 l. 1.3 This European Standard does not describe a

31、 quality assurance system for the control of all stages of the manufacture of the sterilizer. NOTE Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. 1.4 Planning and design of products applying to this European Standard should consider the environmental impact fro

32、m the product during its life cycle. Environmental aspects are addressed in Annex A. NOTE Additional aspects of environmental impact are addressed in EN ISO 14971. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references,

33、only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 764-1:2004, Pressure equipment Part 1: Terminology Pressure, temperature, volume, nominal size !deleted text“ EN 867-3, Non-biological systems for use in steri

34、lizers Part 3: Specification for Class B indicators for use in the Bowie and Dick test !EN 867-5, 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 868-5,

35、Packaging materials and systems for medical devices which are to be sterilized Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction Requirements and test methods EN 1822 (all parts), High efficiency air filters (HEPA and ULPA) EN 10088-1, Stainless steels Part 1: L

36、ist of stainless steels EN 10088-3, Stainless steels Part 3: Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resistant steels for general purposes EN 12953 (all parts), Shell boilers EN 13445 (all parts), Unfired pressure vessels

37、EN 14222, Stainless steel shell boilers EN 60584-2:1993, Thermocouples Part 2: tolerances (IEC 60584-2:1982 + A1:1989) BS EN 285:2006+A2:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license fr

38、om IHS-,-,-EN 285:2006+A2:2009 (E) 6 EN 60751:1995, Industrial platinum resistance thermometer sensors (IEC 60751:1983 + A1:1986) EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements (IEC 61010-1:2001) EN 61010-2-040, Safet

39、y 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 (IEC 61010-2- 040:2005)EN 61326:1997, Electrical equipment for measurement, control and laboratory use EMC r

40、equirements (IEC 61326:1997) EN 61672-1:2003, Electroacoustics Sound level meters Part 1: Specifications (IEC 61672-1:2002) EN 61672-2:2003, Electroacoustics Sound level meters Part 2: Pattern evaluation tests (IEC 61672-2:2003) EN ISO 3746:1995, Acoustics Determination of sound power levels of nois

41、e sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:1995) EN ISO 4017, Hexagon head screws Product grades A and B (ISO 4017:1999) 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 764-1:

42、2004 and the following apply. NOTE Other definitions relevant to validation are given in EN 554. 3.1 access device means used to permit access to restricted parts of the equipment NOTE This may be by dedicated key, code or tool. 3.2 air removal removal of air from the sterilizer chamber and steriliz

43、er load to facilitate steam penetration 3.3 automatic controller device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required stages of the cycle(s) 3.4 biological indicator microbiological test system providing a defined resistance to a speci

44、fied sterilization process ISO/TS 11139:2001, definition 2.4 BS EN 285:2006+A2:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EN 285:2006+A2:2009 (E) 7 3.5 calibration set o

45、f 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 realized by standards IVM:1994, definition

46、 6.11 3.6 chamber depth depth of the sterilizer chamber which is available for the sterilizer load 3.7 chamber height height of the sterilizer chamber which is available for the sterilizer load 3.8 chamber width width of the sterilizer chamber which is available for the sterilizer load 3.9 cycle com

47、plete indication that the sterilization cycle has been completed according to programme and that the sterilized load is ready for removal from the sterilizer chamber 3.10 door lid or similar device provided as a means of closing and sealing the sterilizer chamber 3.11 double ended sterilizer sterili

48、zer in which there is a door at each end of the sterilizer chamber !3.12 endpoint point of the observed change as defined by the manufacturer occurring after the indicator has been exposed to specified stated values EN ISO 11140-1:2005“ 3.13 equilibration time period which elapses between the attainment of the sterilization temperature at the reference measurement point and the attainment of the sterilization temperature at all points within the load 3.14 holding time period fo