1、BS EN ISO 11138-5:2017Sterilization of healthcare products BiologicalindicatorsPart 5: Biological indicators for low-temperature steam and formaldehydesterilization processes (ISO 11138- 5:2017)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11138-5:2017 BR
2、ITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 11138-5:2017. It supersedes BS EN ISO 11138-5:2006 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A lis
3、t 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 contract. Users are responsible for its correct application. The British Standards Institution 2017.Published by BSI Standards L
4、imited 2017ISBN 978 0 580 89835 8 ICS 11.080.01 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2017.Amendments/corrigenda issued since publicationDate
5、T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11138-5 March 2017 ICS 11.080.20 Supersedes EN ISO 11138-5:2006English Version Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde ster
6、ilization processes (ISO 11138-5:2017) Strilisation des produits de sant - Indicateurs biologiques - Partie 5: Indicateurs biologiques pour la strilisation la vapeur deau et au formaldhyde basse temprature (ISO 11138-5:2017) Sterilisation von Produkten fr die Gesundheitsfrsorge - Biologische Indikat
7、oren - Teil 5: Biologische Indikatoren fr Sterilisationsverfahren mit Niedertemperatur-Dampf-Formaldehyd (ISO 11138-5:2017) This European Standard was approved by CEN on 19 January 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givi
8、ng 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 application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three offi
9、cial 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-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of
10、 Austria, Belgium, 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, Serbia, Slovakia, Slovenia,
11、 Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worl
12、dwide for CEN national Members. Ref. No. EN ISO 11138-5:2017 EBS EN ISO 11138-5:2017EN ISO 11138-5:2017 (E) 3 European foreword This document (EN ISO 11138-5:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products in collaboration with Technical Committee CEN
13、/TC 102 “Sterilizers and associated equipment for processing of medical devices”, 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 September 2017 and confli
14、cting national standards shall be withdrawn at the latest by September 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 for identifying any or all such patent rights. This docu
15、ment supersedes EN ISO 11138-5:2006. The standard is a full technical revision of the previous version. The following amendments have been made in comparison with EN ISO 11138-5:2006: requirements on determination of resistance characteristics (9.6) revised. EN ISO 11138 consists of the following pa
16、rts, under the general title Sterilization of health care products Biological indicators: Part 1: General requirements Part 2: Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for moist heat sterilization processes Part 4: Biological indicators for dry h
17、eat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belg
18、ium, 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, Serbia, Slovakia, Slovenia, Spain, Sweden
19、, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11138-5:2017 has been approved by CEN as EN ISO 11138-5:2017 without any modification. BS EN ISO 11138-5:2017ISO 11138-5:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Ge
20、neral requirements . 15 Test organism . 26 Suspension 27 Carrier and primary packaging 28 Inoculated carriers and biological indicators 29 Population and resistance 2Annex A (normative) Method for determination of resistance to low-temperature steam and formaldehyde . 4Annex B (informative) Rational
21、e for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators 6Bibliography 7 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11138-5:2017ISO 11138-5:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of nati
22、onal standards 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. Internat
23、ional organizations, 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.The procedures used to develop this document and those intende
24、d for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .i
25、so .org/ directives).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. Details of any patent rights identified during the development of the document w
26、ill be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the me
27、aning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by
28、Technical Committee ISO/TC 198, Sterilization of health care products.This second edition cancels and replaces the first edition (ISO 11138-5:2006), which has been technically revised.A list of all parts of ISO 11138 can be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 11138-5:20
29、17ISO 11138-5:2017(E)IntroductionISO 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring sterilization processes. This document give
30、s specific requirements for those biological indicators intended for use in low-temperature steam and formaldehyde sterilization processes.Annex B gives rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators.The ISO 11138 series represents the cur
31、rent “state-of-the-art” according to the experts representing manufacturers, users and regulatory authorities involved in developing the standard. The intent is not to promote the use of biological indicators where such use is not advised, but to provide common requirements for the production of tho
32、se biological indicators that are known to be in use today.A standard exists providing general requirements for the validation and control of low-temperature steam and formaldehyde sterilization processes (see ISO 25424).NOTE It is possible that some countries or regions have published other standar
33、ds covering requirements for sterilization or biological indicators.Advice on selection, use and interpretation of results when using biological indicators can be found in ISO 14161. ISO 2017 All rights reserved vBS EN ISO 11138-5:2017BS EN ISO 11138-5:2017Sterilization of health care products Biolo
34、gical indicators Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes1 ScopeThis document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of s
35、terilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.NOTE 2 Requirements for work place safety can be provided by nat
36、ional or regional regulations.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the r
37、eferenced document (including any amendments) applies.ISO 11138-1:2017, Sterilization of health care products Biological indicators Part 1: General requirements3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11138-1 and the following apply.ISO and IEC
38、 maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p s :/ www .iso .org/ obp/ 3.1low-temperature steam and formaldehyde sterilizationprocess incor
39、porating forced air removal, which allows exposure of wrapped goods to steam at sub-atmospheric pressure, and thus at temperatures less than 100 C, with the admission of formaldehyde gas, keeping the sterilizing agent in a steady state throughout the hold time4 General requirementsThe requirements o
40、f ISO 11138-1 apply.INTERNATIONAL STANDARD ISO 11138-5:2017(E) ISO 2017 All rights reserved 1BS EN ISO 11138-5:2017ISO 11138-5:2017(E)5 Test organism5.1 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganisms of demonstrated equivalent performance as r
41、equired by this document.NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus.NOTE 2 Geobacillus stearothermophilus NCIB 8224, DSM 6790, ATCC 7953, ATCC 10149 and ATCC 12980 have been found to be suitable1).5.2 If a test organism other than Geobacillus stearothe
42、rmophilus is used, the suitability of the resistance of that test organism shall be determined.6 SuspensionThe requirements of ISO 11138-1 apply.7 Carrier and primary packaging7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in low-temperature stea
43、m and formaldehyde sterilization processes shall be demonstrated in accordance with the requirements of ISO 11138-1:2017, 5.2 and Annex B.NOTE Carriers based on filter paper might not be suitable because of the chemisorption of formaldehyde on cellulose surfaces.7.2 The exposure conditions to determ
44、ine compliance shall be the following:a) minimum exposure temperature: greater than or equal to 5 C above the manufacturers stated maximum exposure temperature;b) maximum exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, the maximum exposure temperature shall be
45、 greater than or equal to 100 C;c) exposure time: greater than or equal to 160 min.NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a low-temperature steam and formaldehyde sterilization process.8 Inoculated car
46、riers and biological indicatorsThe requirements of ISO 11138-1 apply.9 Population and resistance9.1 The resistance characteristics shall be stated according to ISO 11138-1:2017, 6.4.9.2 The viable count shall be stated with increments less than or equal to 0,1 10nper unit (e.g. per ml of suspension,
47、 per inoculated carrier or per biological indicator).9.3 For inoculated carriers and biological indicators, the viable count shall be greater than or equal to 1,0 105.1) These are examples of suitable products available commercially. This information is given for the convenience of users of this doc
48、ument and does not constitute an endorsement by ISO of these products.2 ISO 2017 All rights reservedBS EN ISO 11138-5:2017ISO 11138-5:2017(E)9.4 The resistance shall be expressed as the D value in mins at 60 C. The D value of each batch/lot of biological indicators or inoculated carriers shall be st
49、ated in minutes to one decimal place at 60 C.9.5 Suspensions, inoculated carriers or biological indicators containing Geobacillus stearothermophilus spores shall have a D60value of greater than or equal to 6 min when tested according to the conditions in Annex A. Other microorganisms shall have D values supporting the application.9.6 The resistance characteristics specified in this document and any other part of ISO 11138 shall be defined using the specific critical variables associated with the referenced steril
