1、April 2010 Translation by DIN-Sprachendienst.English price group 13No 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、07.100.10; 11.080.01!$b9h“1632269www.din.deDDIN EN ISO 11737-2Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation andmaintenance of a sterilization process (ISO 11737-2:2009)English translation of DIN EN ISO 11737-2:2010-04Steri
3、lisation von Medizinprodukten Mikrobiologische Verfahren Teil 2: Prfungen der Sterilitt bei der Definition, Validierung und Aufrechterhaltung einesSterilisationsverfahrens (ISO 11737-2:2009)Englische bersetzung von DIN EN ISO 11737-2:2010-04Strilisation des dispositifs mdicaux Mthodes microbiologiqu
4、es Partie 2: Contrles de strilit pratiqus au moment de la dfinition, de la validation et dela maintenance dun procd de strilisation (ISO 11737-2:2009)Traduction anglaise de DIN EN ISO 11737-2:2010-04SupersedesDIN EN ISO 11737-2:2000-04www.beuth.deIn case of doubt, the German-language original shall
5、be considered authoritative.Document comprises 27 pages04.10 DIN EN ISO 11737-2:2010-04 2 A comma is used as the decimal marker. National foreword This document has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” (Secretariat: ANSI, United States), in collabor
6、ation with Technical Committee CEN/TC 204 “Sterilization of medical devices” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-01-07 AA Sterilisation von Medizinprodukten
7、. This standard contains specifications meeting the essential requirements set out in EU Directives 90/385/EEC on active implantable medical devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostic devices. The DIN Standards corresponding to the International Standards referred to i
8、n this standard are as follows: ISO 9000 DIN EN ISO 9000 ISO 9001 DIN EN ISO 9001 ISO 10012 DIN EN ISO 10012 ISO 11135-1 DIN EN ISO 11135-1 ISO/TS 11135-2 DIN ISO/TS 11135-2 ISO 11137-1 DIN EN ISO 11137-1 ISO 11137-2 DIN EN ISO 11137-2 ISO 11138-2 DIN EN ISO 11138-2 ISO 11737-1 DIN EN ISO 11737-1 IS
9、O 13485 DIN EN ISO 13485 ISO 14160 DIN EN ISO 14160 ISO 14161 DIN EN ISO 14161 ISO 14644-1 DIN EN ISO 14644-1 ISO 14644-4 DIN EN ISO 14644-4 ISO 14644-7 DIN EN ISO 14644-7 ISO 14937 DIN EN ISO 14937 ISO/IEC 17025 DIN EN ISO/IEC 17025 ISO 17665-1 DIN EN ISO 17665-1 Amendments This standard differs fr
10、om DIN EN ISO 11737-2:2000-04 as follows: a) The requirements for quality management system elements have been revised. b) Requirements for the selection of the product have been revised. c) Requirements relating to methods for performing tests of sterility and to the assessment and maintenance of t
11、hese methods have been revised. d) Guidance on tests of sterility has been brought into line with the requirements. e) The standard has been editorially revised. DIN EN ISO 11737-2:2010-04 3 Previous editions DIN EN ISO 11737-2: 2000-04 National Annex NA (informative) Bibliography DIN EN ISO 9000, Q
12、uality management systems Fundamentals and vocabulary DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part
13、 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN ISO/TS 11135-2, Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 DIN EN ISO 11137-1, Sterilization of health care products Ra
14、diation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose DIN EN ISO 11138-2, Sterilization of health care products Biolog
15、ical indicators Part 2: Biological indicators for ethylene oxide sterilization 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 13485, Medical devices Quality management systems Requi
16、rements for regulatory purposes DIN EN ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidance
17、for the selection, use and interpretation of results DIN EN ISO 14644-1, Cleanroom and associated controlled environments Part 1: Classification of air cleanliness DIN EN ISO 14644-4, Cleanrooms and associated controlled environments Part 4: Design, construction and start up DIN EN ISO 14644-7, Clea
18、nrooms and associated controlled environments Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) DIN EN ISO 11737-2:2010-04 4 DIN EN ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the develo
19、pment, validation and routine control of a sterilization process for medical devices DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, va
20、lidation and routine control of a sterilization process for medical devices EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11737-2 November 2009 ICS 07.100.10; 11.080.01 Supersedes EN ISO 11737-2:2000English Version Sterilization of medical devices - Microbiological methods - Part 2: Tests
21、 of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)Strilisation des dispositifs mdicaux - Mthodes microbiologiques - Partie 2: Contrles de strilit pratiqus au moment de la dfinition, de la validation et de la maintenance dun procd de st
22、rilisation (ISO 11737-2:2009) Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 2: Prfungen der Sterilitt bei der Definition, Validierung und Aufrechterhaltung eines Sterilisationsverfahrens (ISO 11737-2:2009) This European Standard was approved by CEN on 28 October 2009. CEN me
23、mbers 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 national standards may be obtained on applica
24、tion to the CEN 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 language and notified to the CEN Management Centre has
25、 the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Por
26、tugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION 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 mean
27、s reserved worldwide for CEN national Members. Ref. No. EN ISO 11737-2:2009: EContents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Quality management system elements .7 5 Selection of product 8 6 Methods for performing tests of sterility 9 7 Assessm
28、ent of method for performing tests of sterility 10 8 Maintenance of the method for performing tests of sterility . 10 Annex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process . 11 Bibliography. 19 Annex ZA (informative) Relationship betw
29、een this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices . 21 Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices 22 Annex ZC (informative) Rel
30、ationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices. 23 DIN EN ISO 11737-2:2010-04 EN ISO 11737-2:2009 (E) 2 Foreword devices” the secretariat of which is held by BSI. This European Standard shall be given the status
31、 of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2010, and conflicting national standards shall be withdrawn at the latest by May 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of pa
32、tent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11737-2:2000. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports ess
33、ential requirements of EU Directives. For relationship with EU Directives, see informative Annexes ZA, ZB and ZC, which are integral parts of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this
34、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, Spain, Sweden, Switzerland and the Un
35、ited Kingdom. Endorsement notice The text of ISO 11737-2:2009 has been approved by CEN as a EN ISO 11737-2:2009 without any modification. DIN EN ISO 11737-2:2010-04 EN ISO 11737-2:2009 (E) 3 This document (EN ISO 11737-2:2009) has been prepared by Technical Committee ISO/TC 198 “Sterilization of hea
36、lth care products” in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical Introduction A sterile medical device is one that is free from viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes requ
37、ire, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device from all sources be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management system
38、s (see, for example, ISO 13485) may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones. The kinetic
39、s of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally best be described by an exponential relationship between the numbers of microorganisms surviving and the extent of treatment with the sterilizing agent; inevitably
40、 this means that there is always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist du
41、ring treatment. It follows that the sterility of any one item in a population subjected to sterilization processing cannot be guaranteed and the sterility of a processed population is defined in terms of the probability of there being a viable microorganism present on a product item. Generic require
42、ments of the quality management system for design and development, production, installation and servicing are given in ISO 900116and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognise tha
43、t, for certain processes used in manufacturing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterili
44、zation process is monitored routinely and the equipment is maintained. International Standards specifying procedures for the development, validation and routine control of the processes used for sterilization of medical devices have been prepared (see ISO 11135-11, ISO 11137-13, ISO 1493712, ISO 141
45、607, ISO 17665-113and ISO 2085714). An element of validation might consist of exposing medical devices to the sterilizing agent with the extent of treatment being reduced relative to that which will be used in routine sterilization processing, in order to provide a knowledge of the resistance to the
46、 agent of the microbial contamination as it occurs naturally on medical devices. Subsequent to this exposure, medical devices are subjected individually to tests of sterility as described in this part of ISO 11737. Examples of the use of such tests are in a) establishing a dose for sterilization by
47、radiation, and b) demonstrating the continued validity of an established sterilization dose. Annex A of this part of ISO 11737 gives guidance on the techniques used and on practical aspects of the requirements. DIN EN ISO 11737-2:2010-04 EN ISO 11737-2:2009 (E) 4 1 Scope 1.1 This part of ISO 11737 s
48、pecifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintain
49、ing a sterilization process. 1.2 This part of ISO 11737 is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process; b) performing a test for sterility (see 3.12); NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or ISO 17665-1. c) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is
