EN 1422-2014 en Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods《医用环氧乙烷灭菌器 灭菌器 要求和试验方法》.pdf

1、BSI Standards PublicationBS EN 1422:2014Sterilizers for medical purposes Ethylene oxide sterilizers Requirements and testmethodsBS EN 1422:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1422:2014. It supersedes BS EN 1422:1997+A1:2009 which is withdrawn.Th

2、e UK participation in its preparation was entrusted 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

3、 contract. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 76557 5ICS 11.080.10Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under th

4、e authority of the Standards Policy and Strategy Committee on 31 May 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 1422:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1422 May 2014 ICS 11.080.10 Supersedes EN 1422:1997+A1:2009English Version Sterilize

5、rs for medical purposes - Ethylene oxide sterilizers - Requirements and test methods Strilisateurs usage mdical - Strilisateurs loxyde dthylne - Exigences et mthodes dessai Sterilisatoren fr medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und Prfverfahren This European Standard was

6、approved by CEN on 17 April 2014. 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. Up-to-date lists and bibliographical references concerning such natio

7、nal standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists 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 langua

8、ge 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,

9、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-

10、CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1422:2014 EBS EN 1422:2014EN 1422:2014 (E) 2 Contents Page Foreword . 4 Introduction 5 1 Scope . 6 2 Normative refere

11、nces . 6 3 Terms and definitions . 7 4 Technical requirements 12 4.1 General . 12 4.1.1 Risk control and usability 12 4.1.2 Materials . 13 4.2 Sterilizer chamber . 13 4.2.1 Chamber size . 13 4.2.2 Doors, closures and interlocks of the sterilizer chamber 13 4.2.3 Test connections . 14 4.3 Design and

12、construction 15 4.3.1 General . 15 4.3.2 EO vaporizers 15 4.3.3 Pipework and fittings 15 4.3.4 Evacuation system 15 4.3.5 Control valves . 16 4.3.6 Thermal insulation 16 4.3.7 Electrical and mechanical safety . 16 4.3.8 Air or inert gas filter 16 4.3.9 Emission control . 16 4.3.10 Framework and pane

13、lling . 17 4.3.11 Loading equipment . 17 4.3.12 Transport . 17 4.4 Indicating, measuring, and recording instruments . 17 4.4.1 General . 17 4.4.2 Temperature sensor 18 4.4.3 Temperature indicating instruments. 18 4.4.4 Pressure sensors 19 4.4.5 Timers and time indicating instruments . 19 4.4.6 Steri

14、lizing cycle counter . 19 4.4.7 Relative humidity (RH) sensors . 19 4.4.8 Ethylene Oxide (EO) concentration-measurement 19 4.4.9 Recording instruments . 20 4.4.10 Indicating instruments . 21 5 Process control . 22 5.1 General . 22 5.2 Software verification and validation . 23 5.3 Sterilization cycle

15、 and automatic control . 23 5.3.1 Automatic control . 23 5.3.2 Sterilization cycle 24 5.4 Override of automatic control 27 5.5 Fault 27 6 Performance requirements 28 BS EN 1422:2014EN 1422:2014 (E) 3 6.1 Sterilizing performance 28 6.1.1 Loading configuration 28 6.1.2 Physical parameters . 28 6.1.3 M

16、icrobiological efficacy . 28 6.2 EO removal (flushing) . 29 6.3 Aeration 29 7 Sound power . 29 8 Packaging, marking and labelling . 29 9 Information to be supplied by the manufacturer . 30 10 Service and local environment 32 10.1 General . 32 10.2 Electricity . 33 10.3 Sterilant 33 10.4 Circulation

17、systems 33 10.5 Steam . 33 10.6 Water 34 10.7 Air and inert gasses 34 10.8 Drainage and discharges . 34 10.9 Ventilation and environment 34 10.10 Lighting 34 Annex A (normative) Test instrumentation . 35 Annex B (normative) Leak test cycle . 36 Annex C (normative) Sterilizer chamber profile testing.

18、 37 C.1 Sterilizer chamber internal surfaces . 37 C.2 Empty sterilizer chamber . 37 Annex D (normative) Microbiological test for EO sterilizers . 38 D.1 General . 38 D.2 Test equipment 38 D.3 Procedure 39 D.4 Interpretation of results 40 Annex E (informative) Environmental aspects . 41 E.1 Environme

19、ntal aspects regarding the life cycle of EO sterilizers 41 E.2 EO (brief description) . 41 E.3 Environmental impact 41 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 44 Bibliography . 48 BS EN 1422:2014EN

20、 1422:2014 (E) 4 Foreword This document (EN 1422:2014) 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

21、or by endorsement, at the latest by November 2014 and conflicting national standards shall be withdrawn at the latest by May 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible fo

22、r identifying any or all such patent rights. This document supersedes EN 1422:1997+A1:2009. 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 D

23、irective, see informative Annex ZA, which is an integral part of this document. Annexes A, B, C and D are normative and form part of this European Standard. Annexes E and ZA are for information only. The standard is a full technical revision of the previous version. The following amendments have bee

24、n made in comparison with EN 1422:1997+A1:2009: new specification of the scope of the standard, e.g. explicit exclusion of sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber and removal of different types A and B of EO-sterilizers

25、 ; normative references have been updated; layout of the standard brought in line with the standard for LTSF-sterilization (EN 14180); the additional requirements from the machinery directive, introduced by the revision of the medical devices directive 2007/47/EC have been addressed (see revised Ann

26、ex ZA), i.e. update of technical requirements and Tables ZA.1 and ZA.2; requirements have been rephrased to be performance requirements instead of design requirements; addition of an environmental checklist; Annex B has been thoroughly revised and Annex D has been deleted. According to the CEN-CENEL

27、EC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Ice

28、land, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1422:2014EN 1422:2014 (E) 5 Introduction Ethylene oxide (EO) sterilizers employing EO gas as the sterilant,

29、 either as a pure gas or in admixture with other gases, are primarily used for the sterilization of heat labile material or product. The EO-sterilizer specified in this European standard can be used for medical, dental, pharmaceutical veterinary and industrial or related purposes. The tests describe

30、d in this European Standard are reference tests intended for use in demonstrating conformity with the performance requirements specified in this European Standard. They can be used in type tests, works tests, in validation and re-validation tests, or in periodic and routine tests carried out by the

31、user. Validation and routine control of sterilization processes are essential to ensure their efficacy. This European Standard does not cover validation and routine control of EO processes (see prEN ISO 11135:2012). EO is a highly reactive chemical which can present a toxic, flammable or explosive h

32、azard if incorrectly handled (see Annex 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 Creutzfeld-Jakob disease. Pla

33、nning and design of products complying with this standard should consider not only technical issues but also the environmental impact from the product during its life-cycle. Environmental aspects are addressed in Annex E of this standard. By performing tests concurrently and/or in a logical sequence

34、, the total number of tests carried out and waste arising from such tests, is reduced. As a result the burden on the environment can be reduced (see also Annex E). BS EN 1422:2014EN 1422:2014 (E) 6 1 Scope This European Standard specifies the requirements and the relevant tests for automatically con

35、trolled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working

36、 at super or sub-atmospheric pressure for: the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads d

37、escribed in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads. This European Standard does not specify those tests which are necessary to dete

38、rmine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012. This European Standard does not specify requirements for occupational safety associated with the design a

39、nd operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist. This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or

40、into a flexible chamber. NOTE 2 See EN ISO 14937. This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This European Standard does not cover

41、analytical methods for determining levels of residual EO and/or its reaction products. NOTE 3 For further information see ISO 10993-7. 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

42、 references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 764-7, Pressure equipment - Part 7: Safety systems for unfired pressure equipment EN 868-4, Packaging for terminally sterilized medical devices -

43、Part 4: Paper bags - Requirements and test methods EN 8685, Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods BS EN 1422:2014EN 1422:2014 (E) 7 EN 13445-3, Unfired pressure vessel

44、s - Part 3: Design EN 13445-5, Unfired pressure vessels - Part 5: Inspection and testing EN 14222, Stainless steel shell boilers EN 610101:2010, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements (IEC 61010-1:2010) EN 61010-2-040:200

45、5, 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 (IEC 61010-2-040:2005) EN 61326-1:2006, Electrical equipment for measurement, control and laboratory

46、 use EMC requirements Part 1: General requirements (IEC 61326-1:2005) EN ISO 3746:2010, 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 (ISO 3746:2010) EN ISO

47、 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) prEN ISO 11135:2012, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medica

48、l devices (ISO/DIS 11135:2012) EN ISO 11138-1, Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1) EN ISO 11138-2, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro

49、cesses (ISO 11138-2) EN ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1) EN ISO 14971:2012, Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 aeration part of the sterilization process during which ethylene oxide and/or its reaction products desorb from t