1、October 2014Translation by DIN-Sprachendienst.English price group 31No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 11.080.20!%;tj“2248171www.din.deDDIN EN ISO 11135Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control ofa sterilization process for medical devices (ISO 11135:2014);English version EN ISO 11135:2014,English translation of DIN EN ISO 1
3、1135:2014-10Sterilisation von Produkten fr die Gesundheitsfrsorge Ethylenoxid Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung einesSterilisationsverfahrens fr Medizinprodukte (ISO 11135:2014);Englische Fassung EN ISO 11135:2014,Englische bersetzung von DIN EN ISO 11135:2014-1
4、0Strilisation des produits de sant Oxyde dthylne Exigences de dveloppement, de validation et de contrle de routine dun processus destrilisation pour des dispositifs mdicaux (ISO 11135:2014);Version anglaise EN ISO 11135:2014,Traduction anglaise de DIN EN ISO 11135:2014-10SupersedesDIN EN ISO 11135-1
5、:2007-08andDIN ISO/TS 11135-2:2010-01www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 92 pages10.14 DIN EN ISO 11135:2014-10 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11135:2014) has been prepared b
6、y Technical Committee ISO/TC 198 “Sterilization of health care products” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the DIN-Normenauss
7、chuss Medizin (DIN Standards Committee Medicine), Working Committees NA 063-01-07 AA Sterilisation von Medizinprodukten and NA 063-04-02 AA Niedertemperatur-Sterilisatoren. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 9000 DIN EN ISO
8、 9000 ISO 9001 DIN EN ISO 9001 ISO 10012 DIN EN ISO 10012 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-7 DIN EN ISO 10993-7 ISO 11138-1 DIN EN ISO 11138-1 ISO 11138-2 DIN EN ISO 11138-2 ISO 11140-1 DIN EN ISO 11140-1 ISO 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 11737-1 DIN EN ISO 11
9、737-1 ISO 11737-2 DIN EN ISO 11737-2 ISO 13485 DIN EN ISO 13485 ISO 14001 DIN EN ISO 14001 ISO 14040 DIN EN ISO 14040 ISO 14161 DIN EN ISO 14161 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 15883-1 DIN EN ISO 15883-1 ISO 15883-2 DIN EN ISO 15883-2 ISO 15883-4 DIN EN ISO 15883-4 ISO/TS 1
10、5883-5 DIN ISO/TS 15883-5 ISO 15883-6 DIN EN ISO 15883-6 ISO/DIS 15883-7 E DIN EN ISO 15883-7 ISO 17664 DIN EN ISO 17664 ISO 22442-1 DIN EN ISO 22442-1 ISO 22442-2 DIN EN ISO 22442-2 ISO 22442-3 DIN EN ISO 22442-3 ISO/TS 16775-2 DIN ISO/TS 16775-2 IEC 61010-1 DIN EN 61010-1 IEC 61010-2-040 DIN EN 61
11、010-2-040 Amendments This standard differs from DIN EN ISO 11135-1:2007-08 and DIN ISO/TS 11135-2:2010-01 as follows: a) Part 1, Requirements for the development, validation and routine control of a sterilization process for medical devices and Part 2, Guidance on the application of ISO 11135-1 have
12、 been revised and combined into one standard; b) the number of the standard has been changed to read “EN ISO 11135”; DIN EN ISO 11135:2014-10 3 c) the scope has been extended to include applications in industrial and health care facilities, and it acknowledges the similarities and differences betwee
13、n the two applications; d) the term “processing group” has been changed to “processing category” (3.31) and the definition has been revised; the definitions of “sterile barrier system” (3.44), “dew point” (3.10) and “virgin material” (3.58) have been supplemented; e) requirements in Subclauses 5.2 “
14、Sterilizing agent” and 5.5 “Safety and environment” have been revised; f) Clause 6 “Process and equipment characterization” has been revised to be in line with the guidance on the application (Part 2 of ISO 11135); g) requirements for load configuration (Subclause 7.1.5) have been added to supplemen
15、t Clause 7 “Product definition”; h) Clause 8 “Process definition” has been revised; i) Clause 9 “Validation” has been revised to be in line with the guidance on the application (Part 2 of ISO 11135); Subclause 9.1 “General” has been supplemented; j) requirements for routine monitoring when using bio
16、logical indicators (Subclause 10.3) and chemical indicators (Subclause 10.4) and for parametric release (Subclause 10.5) have been supplemented to be in line with the guidance on the application (Part 2 of ISO 11135); k) Clause 11 “Product release from sterilization” has been revised to be in line w
17、ith the guidance on the application (Part 2 of ISO 11135); l) Subclauses 12.3 “Requalification” and 12.4 “Assessment of change” have been revised; m) Subclause 12.5 “Assessment of equivalence” has been supplemented; n) Annexes A and B have been revised to be in line with the guidance on the applicat
18、ion (Part 2 of ISO 11135); o) Annex C (informative) “Temperature sensors, RH sensors and biological indicator numbers” has been added; p) Annex D “Guidance on the application of the normative requirements” has been revised to be in line with the guidance on the application (Part 2 of ISO 11135), for
19、 example Subclauses D.5.5 “Safety and the environment”, D.6 “Process and equipment characterization” and requalification; q) Annex E (normative) “Single lot release” has been added; r) the standard has been editorially revised. Previous editions DIN 58948-6: 1982-07, 1987-10, 2003-04 DIN EN 550: 199
20、4-11 DIN EN ISO 11135-1: 2007-08 DIN ISO/TS 11135-2: 2008-11, 2010-01 DIN EN ISO 11135:2014-10 4 National Annex NA (informative) Bibliography DIN EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements DIN EN 61010-2, Safety r
21、equirements for electrical equipment for measurement, control and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials DIN EN ISO 9000, Quality management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management sys
22、tems Requirements DIN EN ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-7, Biological evaluation of m
23、edical devices Part 7: Ethylene oxide sterilization residuals DIN EN ISO 11138-1, Sterilization of health care products Biological indicators Part 1: General require-ments DIN EN ISO 11138-2, Sterilization of health care products Biological indicators Part 2: Biological indica-tors for ethylene oxid
24、e sterilization processes DIN EN ISO 11140-1, Sterilization of health care products Chemical indicators Part 1: General require-ments DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for mate-rials, sterile barrier systems and packaging systems DIN EN ISO
25、11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes DIN EN ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products DIN EN ISO 11737-2
26、, Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory pur-poses DIN EN ISO 14001, Environmental
27、management systems Requirements with guidance for use DIN EN ISO 14040, Environmental management Life cycle assessment Principles and framework DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results DIN EN ISO 11135
28、:2014-10 5 DIN EN ISO 14937, 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 DIN EN ISO 14971, Medical devices Application of risk management to m
29、edical devices DIN EN ISO 15883-1, Washer-disinfectors Part 1: General requirements, terms and definitions and tests DIN EN ISO 15883-2, Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employ-ing thermal disinfection for surgical instruments, anaesthetic equipment, bowls,
30、dishes, receivers, utensils, glassware, etc. DIN EN ISO 15883-4, Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employ-ing chemical disinfection for thermolabile endoscopes DIN EN ISO 15883-5, Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning e
31、fficacy DIN EN ISO 15883-6, Washer-disinfectors Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment E DIN EN ISO 15883-7, Washer-disinfectors Part 7: Requirements and tests for washer-disinfecto
32、rs employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices DIN EN ISO 22442-1, Medical d
33、evices utilizing animal tissues and their derivatives Part 1: Application of risk management DIN EN ISO 22442-2, Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling DIN EN ISO 22442-3, Medical devices utilizing animal tissues and their
34、 derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents DIN ISO/TS 16775-2, Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1 DIN EN ISO 11135:2014-10 6 This page is i
35、ntentionally blank EN ISO 11135 July 2014 ICS 11.080.01 Supersedes CEN ISO/TS 11135-2:2008, EN ISO 11135-1:2007English Version Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO
36、 11135:2014)Strilisation des produits de sant - Oxyde dthylne - Exigences de dveloppement, de validation et de contrle de routine dun processus de strilisation pour des dispositifs mdicaux (ISO 11135:2014) Sterilisation von Produkten fr die Gesundheitsfrsorge -Ethylenoxid - Anforderungen an die Entw
37、icklung,Validierung und Lenkung der Anwendung einesSterilisationsverfahrens fr Medizinprodukte(ISO 11135:2014)This European Standard was approved by CEN on 28 June 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
38、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-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (En
39、glish, 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
40、, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerla
41、nd, Turkey andUnited Kingdom. CEN-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 ISO 11135:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIO
42、NEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContents Page Foreword . 4 Introduction . 5 1 Scope . 7 1.1 Inclusions 7 1.2 Exclusions 7 2 Normative references. 8 3 Terms and definitions 9 4 Quality management systems 17 4.1 Documentation . 17 4.2 Management responsibi
43、lity . 17 4.3 Product realization . 17 4.4 Measurement, analysis and improvement Control of nonconforming product 17 5 Sterilizing agent characterization . 17 5.1 General 17 5.2 Sterilizing agent 18 5.3 Microbicidal effectiveness 18 5.4 Material effects . 18 5.5 Safety and the environment 18 6 Proce
44、ss and equipment characterization 18 6.1 General 18 6.2 Process characterization . 18 6.3 Equipment characterization 19 7 Product definition . 20 7.1 General 20 7.2 Product safety, quality and performance 21 7.3 Microbiological quality 21 7.4 Documentation . 21 8 Process definition 21 9 Validation 2
45、2 9.1 General 22 9.2 Installation qualification, IQ 23 9.3 Operational qualification, OQ . 23 9.4 Performance qualification, PQ 24 9.5 Review and approval of validation . 26 10 Routine monitoring and control . 28 11 Product release from sterilization 29 12 Maintaining process effectiveness . 29 12.1
46、 General 29 12.2 Maintenance of equipment 30 12.3 Requalification 30 12.4 Assessment of change 30 12.5 Assessment of equivalence 31 2DIN EN ISO 11135:2014-10EN ISO 11135:2014 (E) 3DIN EN ISO 11135:2014-10EN ISO 11135:2014 (E) Annex A (normative) Determination of lethal rate of the sterilization proc
47、ess Biological indicator/bioburden approach 32 Annex B (normative) Conservative determination of lethal rate of the sterilization process Overkill approach . 33 Annex C (informative) Temperature sensors, RH sensors and biological indicator numbers 35 Annex D (informative) Guidance on the application
48、 of the normative requirements . 38 Annex E (normative) Single Lot Release . 80 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC 82 Annex ZB (informative) Relationship between this European Standard and the Essential Require
49、ments of Directive 93/42/EEC 83 Bibliography 84 ForewordThis document (EN ISO 11135:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices” the secretariat of which is held by BSI. This European Standard shall be given the status of a national stan
