1、BRITISH STANDARDBS EN ISO 11737-1:2006Incorporating corrigendum May 2007Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on productsICS 07.100.10; 11.080.01g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44
2、g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 11737-1:2006This British Standard waspublished under the authorityof the Standards Policy andStrategy Committee on 28 April 2006 BSI 2011ISBN 978 0 580 75197 4National fo
3、rewordThis British Standard is the UK implementation of EN ISO 11737-1:2006. It isidentical with ISO 11737-1:2006, incorporating corrigendum May 2007. Itsupersedes BS EN 1174-1:1996, BS EN 1174-2:1997 and BS EN 1174-3:1997which are withdrawn.The UK participation in its preparation was entrusted to T
4、echnical CommitteeCH/198, Sterilization of medical instruments.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. C
5、ompliance with a British Standard cannot confer immunity fromlegal obligations.Amendments/corrigenda issued since publicationDate Comments30 June 2008 Implementation of ISO corrigendum May 2007.Correction to second paragraph of A.7.230 June 2011Implementation of CEN endorsement 2009 of ISO corrigend
6、um May 2007EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11737-1 April 2006 ICS 07.100.10; 11.080.01 Supersedes EN 1174-1:1996, EN 1174-2:1996, EN 1174-3:1996 English Version Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganis
7、ms on products (ISO 11737-1:2006) Strilisation des dispositifs mdicaux - Mthodes microbiologiques - Partie 1: Dtermination dune population de micro-organismes sur des produits (ISO 11737-1:2006)Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 1: Bestimmung der Population von Mi
8、kroorganismen auf Produkten (ISO 11737-1:2006) This European Standard was approved by CEN on 23 March 2006. 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 alterat
9、ion. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translat
10、ion under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hung
11、ary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centr
12、e: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11737-1:2006: EForeword This document (EN ISO 11737-1:2006) has been prepared by Technical Committee ISO/TC 198 “Sterilization of healt
13、h 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 standard, either by publication of an identical text or by endorsement, at the latest by O
14、ctober 2006, and conflicting national standards shall be withdrawn at the latest by October 2006. This document supersedes EN 1174-1:1996, EN 1174-2:1996 and EN 1174-3:1996. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associatio
15、n, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to impl
16、ement this European Standard: Austria, Belgium, 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 Unite
17、d Kingdom. Endorsement notice The text of ISO 11737-1:2006 has been approved by CEN as EN ISO 11737-1:2006 without any modifications. Endorsement notice The text of ISO 11737-1:2006/Cor.1:2007 has been approved by CEN as a European Corrigendumwithout any modification. _ _ _ _ BS EN ISO 11737-1:2006E
18、N ISO 11737-1:2006 (E)iiiContents Page Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Quality management system elements 4 4.1 Documentation 4 4.2 Management responsibility . 4 4.3 Product realization 4 4.4 Measurement, analysis and improvement Control of nonconfo
19、rming product 5 5 Selection of product . 5 5.1 General. 5 5.2 Sample item portion (SIP) 5 6 Methods of determination and microbial characterization of bioburden . 6 6.1 Determination of bioburden. 6 6.2 Microbial characterization of bioburden 7 7 Validation of method for determining bioburden 7 8 Ro
20、utine determination of bioburden and interpretation of data 7 9 Maintenance of the method of determination of bioburden. 8 9.1 Changes to the product and/or manufacturing process 8 9.2 Changes to the method of determination of bioburden . 8 9.3 Revalidation of the method of determination of bioburde
21、n . 8 Annex A (informative) Guidance on determination of a population of microorganisms on product 9 Annex B (informative) Guidance on methods of determination of bioburden. 22 Annex C (informative) Validation of bioburden methods. 31 Bibliography . 34 Annex ZA (informative) Relationship between thi
22、s European Standard and the EssentialRequirements of EU Directives 90/385/EEC concerning active implantable medical devices,93/42/EEC concerning medical devices and 98/79/EC concerning in vitro diagnosticmedical devices . 36 BS EN ISO 11737-1:2006EN ISO 11737-1:2006 (E)blankvIntroduction A sterile m
23、edical device is one that is free of viable microorganisms. International standards that specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical
24、device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see, for example, ISO 13485) may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such
25、 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 kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical de
26、vices 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 this means that there is always a finite probability that a microorganism may survive regardless of the extent of tr
27、eatment 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 during treatment. It follows that the sterility of any one product in a population subjected to sterilization processin
28、g 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 requirements of the quality management system for design and development, production, installation and servicing are give
29、n in ISO 9001 and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognize that, for certain processes used in manufacturing, the effectiveness of the process cannot be fully verified by subseq
30、uent 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 sterilization process is monitored routinely and the equipment is maintained. International Standards specifying procedure
31、s for the validation and routine control of the processes used for the sterilization of medical devices have been prepared (see, for example, ISO 11135, ISO 11137 series and ISO 17665). However, it is important to be aware that exposure to a properly validated and accurately controlled sterilization
32、 process is not the only factor associated with the provision of assurance that the product is sterile and, in this respect, suitable for its intended use. Furthermore, for the effective validation and routine control of a sterilization process, it is important to be aware of the microbiological cha
33、llenge that is presented in the process, in terms of number, characteristics and properties of microorganisms. The term bioburden is used to describe the population of viable microorganisms present on or in product and/or a sterile barrier system. A knowledge of bioburden can be used in a number of
34、situations as part of: validation and revalidation of sterilization processes; routine monitoring for control of manufacturing processes; monitoring of raw materials, components or packaging; assessment of the efficiency of cleaning processes; an overall environmental monitoring programme. Bioburden
35、 is the sum of the microbial contributions from a number of sources, including raw materials, manufacturing of components, assembly processes, manufacturing environment, assembly/manufacturing aids (e.g., compressed gases, water, lubricants), cleaning processes and packaging of finished product. To
36、control bioburden, attention must be given to the microbiological status of these sources. BS EN ISO 11737-1:2006EN ISO 11737-1:2006 (E)vi It is not possible to enumerate the bioburden exactly and, in practice, a determination of bioburden is made using a defined method. Definition of a single metho
37、d for use in the determination of bioburden in all situations is not practicable because of the wide variety of designs and materials of construction of medical devices. Nor is it possible to define a single technique to be used in all situations for the removal of microorganisms in preparation for
38、enumeration. Furthermore, the selection of conditions for enumeration of microorganisms will be influenced by the types of microorganism likely to be present on or in medical devices. This part of ISO 11737 specifies the requirements to be met in the determination of bioburden. The requirements are
39、the normative parts of this part of ISO 11737 with which compliance is claimed. The guidance given in the informative annexes is not normative and is not provided as a checklist for auditors. The guidance provides explanations and methods that are regarded as being a suitable means for complying wit
40、h the requirements. Methods other than those given in the guidance may be used, if they are effective in achieving compliance with the requirements of this part of ISO 11737. BS EN ISO 11737-1:2006EN ISO 11737-1:2006 (E)1Sterilization of medical devices Microbiological methods Part 1: Determination
41、of a population of microorganisms on products 1 Scope This part of ISO 11737 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package. NOTE 1 The nature and
42、 extent of microbial characterization is dependent on the intended use of the bioburden data. This part of ISO 11737 does not specify requirements for the enumeration or identification of viral or protozoan contaminants. NOTE 2 Furthermore, the requirements specified in this part of ISO 11737 are no
43、t intended to address the removal and detection of the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. This part of ISO 11737 does not specify requirements for the microbiological monitoring of the environment in which
44、medical devices are manufactured. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) a
45、pplies. ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment ISO 13485:2003, Medical devices Quality management systems Requirements for regulatory purposes ISO/IEC 17025:2005, General requirements for the competence of testing and calibration labo
46、ratories BS EN ISO 11737-1:2006EN ISO 11737-1:2006 (E)2 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 bioburden population of viable microorganisms on or in product and/or sterile barrier system ISO/TS 11139:2006, definition 2.2 3.2 correct
47、ion action to eliminate a detected nonconformity NOTE A correction can be made in conjunction with a corrective action (3.4). ISO 9000:2005, definition 3.6.6 3.3 correction factor numerical value applied to compensate for incomplete removal from product and/or culture of microorganisms 3.4 correctiv
48、e action action to eliminate the cause of a detected nonconformity or other undesirable situation NOTE 1 There can be more than one cause for a nonconformity. NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action (3.9) is taken to prevent occurrence. NOTE 3 There is a dis
49、tinction between correction (3.2) and corrective action. ISO/TS 11139:2006, definition 2.8 3.5 culture conditions combination of growth media and manner of incubation used to promote germination, growth and/or multiplication of microorganisms NOTE The manner of incubation may include the temperature, time and any other conditions specified for incubation. ISO/TS 11139:2006, definition 2.10 3.6 establish determine by theoretical evaluation and confirm by experimentation ISO/TS 11139:2006, definition 2.17 3.7 medical device instrum
