1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Part 1: General requirements The European Standard EN ISO 11138-1:2006 has the status of a British
2、StandardICS 11.080.01Sterilization of health care products Biological indicators BRITISH STANDARDBS EN ISO 11138-1:2006BS EN ISO 11138-1:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2006 BSI 2006ISBN 0 580 48856 XCross-referenc
3、esThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Sta
4、ndards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover
5、, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 38, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publ
6、icationAmd. No. Date CommentsA list of organizations represented on this committee can be obtained on request to its secretary. present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related in
7、ternational and European developments and promulgate them in the UK.National forewordThis British Standard is the official English language version of EN ISO 11138-1:2006. It is identical with ISO 11138-1:2006. It supersedes BS EN 866-1:1997 which is withdrawn.The UK participation in its preparation
8、 was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, which has the responsibility to: aid enquirers to understand the text;EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11138-1July 2006ICS 11.080.01 Supersedes EN 866-1:1997 English VersionSterilization of h
9、ealth care products - Biological indicators - Part1: General requirements (ISO 11138-1:2006)Strilisation des produits de sant - Indicateurs biologiques- Partie 1: Exigences gnrales (ISO 11138-1:2006)Sterilisation von Produkten fr die Gesundheitsfrsorge -Biologische Indikatoren - Teil 1: Allgemeine A
10、nforderungen(ISO 11138-1:2006)This European Standard was approved by CEN on 7 June 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists
11、 and bibliographical references concerning such nationalstandards 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 translationunder the responsibi
12、lity of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Ital
13、y, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Br
14、ussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11138-1:2006: EForeword This document (EN ISO 11138-1:2006) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration
15、with 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 January 2007, and conflicting natio
16、nal standards shall be withdrawn at the latest by January 2007. This document supersedes EN 866-1:1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Re
17、public, 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. Endorsement notice The text of ISO 11138-1:2006 has b
18、een approved by CEN as EN ISO 11138-1:2006 without any modifications. EN ISO 11138-1:2006Reference numberISO 11138-1:2006(E)INTERNATIONAL STANDARD ISO11138-1Second edition2006-07-01Sterilization of health care products Biological indicators Part 1: General requirements Strilisation des produits de s
19、ant Indicateurs biologiques Partie 1: Exigences gnrales EN ISO 11138-1:2006ii iiiContents Page Foreword iv Introduction v 1 Scope . 1 1.1 General. 1 1.2 Exclusions . 1 2 Normative references . 1 3 Terms and definitions. 2 4 General manufacturing requirements. 4 4.1 Manufacturing controls 4 4.2 Test
20、organism . 5 4.3 Information supplied by manufacturer (labelling). 6 4.4 Storage and transport 6 5 Specific manufacturing requirements 7 5.1 Suspensions 7 5.2 Carrier, primary and secondary packaging . 7 5.3 Inoculated carrier 8 5.4 Biological indicators. 8 5.5 Self-contained biological indicators.
21、8 6 Determination of resistance 8 6.1 General resistance requirements 8 6.2 Test organism . 9 6.3 Population of test organisms 9 6.4 Resistance characteristics 9 6.5 Test conditions . 10 7 Culture conditions 10 7.1 Incubator 10 7.2 Growth medium. 10 7.3 Incubation 10 Annex A (normative) Determinatio
22、n of viable count 11 Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes 13 Annex C (normative) D value determination by survivor curve method 15 Annex D (normative) D value determination by fraction negative method 19
23、 Annex E (normative) Survival-kill response characteristics . 35 Annex F (informative) Relationship between components of biological indicators . 36 Bibliography . 37 EN ISO 11138-1:2006iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standar
24、ds bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organi
25、zations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in
26、 the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 %
27、of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11138-1 was prepared by Technical Committee ISO/TC 198, Ster
28、ilization of health care products. This second edition cancels and replaces the first edition (ISO 11138-1:1994), which has been technically revised. ISO 11138 consists of the following parts, under the general title Sterilization of health care products Biological indicators: Part 1: General requir
29、ements Part 2: Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for moist heat sterilization processes Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilizati
30、on processes EN ISO 11138-1:2006vIntroduction This part of ISO 11138 specifies general requirements for production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monit
31、oring of sterilization processes. Subsequent parts of ISO 11138 provide additional specific requirements for biological indicators for defined sterilization processes. A graphic description of a biological indicator and its components is presented in Annex F. The presentation includes the two types
32、of biological indicator which are covered by ISO 11138. This shows that inoculated carriers can be presented directly to the sterilizing agent without prior packaging, or included in a primary package that permits access by the sterilizing agent. The resistance characteristics depend on the type of
33、test organism, its numbers, the method of preparation and the effects of the primary package. Advice on selection, use and interpretation of results of biological indicators can be found in ISO 141617. For any individual sterilization process, including those covered in subsequent parts of ISO 11138
34、, the resistance of the biological indicator will also depend on its microenvironment during testing. In theory, this could lead to an infinite variation in the preparation of biological indicators. Moreover, a sterilization process could be manipulated in infinite variety to suit each possible set
35、of conditions to which products could be exposed. It has therefore been routine practice to manufacture biological indicators that, when exposed to a set of conditions in a defined sterilization process, provide resistance characteristics expressed as D values and, where relevant, z values. Such val
36、ues are set out in the subsequent parts of ISO 11138. ISO 11138, parts 1 to 5 represent the current “state-of-the-art” according to the experts representing manufacturers, users and regulatory authorities involved in developing this International Standard. Biological indicators for specific steriliz
37、ation processes not covered by reference test conditions in subsequent parts of ISO 11138 should comply with the general requirements in this part, including the resistance testing procedures. Such biological indicators might not be well enough described, or might be used for novel sterilization pro
38、cesses, or might be represented by isolated bioburden microorganisms. If microorganisms other than risk group 1 (WHO,199327) are included in these biological indicators, the appropriate containment and safety levels must be met. Standards exist providing requirements for the validation and control o
39、f sterilization processes (see Bibliography). NOTE Some countries or regions might have published other standards covering requirements for sterilization or biological indicators (see Bibliography). EN ISO 11138-1:2006blank1Sterilization of health care products Biological indicators Part 1: General
40、requirements 1 Scope 1.1 General 1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine
41、monitoring of sterilization processes. 1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no spe
42、cific subsequent part is provided, this part applies. NOTE National or regional regulations may apply. 1.2 Exclusions This part of ISO 11138 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combi
43、ne physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This part of ISO 11138, however, could contain elements relevant to such microbiological test systems. 2 Normative references The following referenced do
44、cuments 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) applies. ISO 8601, Data elements and interchange formats Information interchange Repr
45、esentation of dates and times ISO 11135:1994, Medical devices Validation and routine control of ethylene oxide sterilization ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical device
46、s ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose ISO 11137-3, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for mat
47、erials, sterile barrier systems and packaging systems EN ISO 11138-1:20062 ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes ISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determ
48、ination of a population of microorganisms on products ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes ISO 15223, Symbols to be used with medical device labels, labelling and information to be supplied ISO 17665-1, Sterilization of health care products Moist
49、 heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 biological indicator test system containing viable microorganisms providing a defined resistance to a specified sterilization process
