EN ISO 11138-4-2017 en Sterilization of health care products - Biological indicators - Part 4 Biological indicators for dry heat sterilization processes《医疗保健产品的灭菌生物指示剂-第4部分 干热灭菌生物指.pdf

《EN ISO 11138-4-2017 en Sterilization of health care products - Biological indicators - Part 4 Biological indicators for dry heat sterilization processes《医疗保健产品的灭菌生物指示剂-第4部分 干热灭菌生物指.pdf》由会员分享，可在线阅读，更多相关《EN ISO 11138-4-2017 en Sterilization of health care products - Biological indicators - Part 4 Biological indicators for dry heat sterilization processes《医疗保健产品的灭菌生物指示剂-第4部分 干热灭菌生物指.pdf（20页珍藏版）》请在麦多课文档分享上搜索。

1、BS EN ISO 11138-4:2017Sterilization of healthcare products BiologicalindicatorsPart 4: Biological indicators for dry heatsterilization processes (ISO 11138-4:2017)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 11138-4:2017 BRITISH STANDARDNational foreword

2、This British Standard is the UK implementation of EN ISO 11138-4:2017. It supersedes BS EN ISO 11138-4:2006 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.A list of organizations represented

3、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 Limited 2017ISBN 978 0 580 89834

4、 1 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 T e x t a f f e c t e dEUROPEAN

5、 STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11138-4 March 2017 ICS 11.080.20 Supersedes EN ISO 11138-4:2006English Version Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017) Strilisation des produ

6、its de sant - Indicateurs biologiques - Partie 4: Indicateurs biologiques pour la strilisation la chaleur sche (ISO 11138-4:2017) Sterilisation von Produkten fr die Gesundheitsfrsorge - Biologische Indikatoren - Teil 4: Biologische Indikatoren fr Sterilisationsverfahren mit Heiluft (ISO 11138-4:2017

7、) 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 giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical r

8、eferences 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 (English, French, German). A version in any other language made by translation under the responsibility of a

9、 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, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Maced

10、onia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISAT

11、ION 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 worldwide for CEN national Members. Ref. No. EN ISO 11138-4:2017 EBS EN ISO 11138-4:2017EN ISO 11138-4:2017 (E) 3 European for

12、eword This document (EN ISO 11138-4:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products in collaboration with Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is held by DIN.

13、 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 conflicting national standards shall be withdrawn at the latest by September 2017. Attention is drawn to the possibility that so

14、me 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 document supersedes EN ISO 11138-4:2006. The standard is a full technical revision of the previous version. The following amen

15、dments have been made in comparison with EN ISO 11138-4:2006: requirements on determination of resistance characteristics (9.6) revised. EN ISO 11138 consists of the following parts, under the general title Sterilization of health care products Biological indicators: Part 1: General requirements Par

16、t 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 sterilization process

17、es According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,

18、Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11138-4:2017 has been approved by CEN as

19、EN ISO 11138-4:2017 without any modification. BS EN ISO 11138-4:2017ISO 11138-4:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 General requirements . 15 Test organism . 16 Suspension 27 Carrier and primary packaging 28 Inoculated carriers and biologic

20、al indicators 29 Population and resistance 2Annex A (normative) Method for determination of resistance to dry heat sterilization . 4Annex B (normative) Calculation of z value 5Bibliography 8 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11138-4:2017ISO 11138-4:2017(E)ForewordISO (the Intern

21、ational Organization for Standardization) is a worldwide federation of national 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 b

22、een established has the right to be represented on that committee. International 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 sta

23、ndardization.The procedures used to develop this document and those intended 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 accord

24、ance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .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. Detai

25、ls of any patent rights identified during the development of the document will 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

26、endorsement.For an explanation on the voluntary nature of standards, the meaning 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 follo

27、wing URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.This second edition cancels and replaces the first edition (ISO 11138-4:2006), which has been technically revised.A list of all the parts of ISO 11138 can

28、be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 11138-4:2017ISO 11138-4:2017(E)IntroductionISO 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended f

29、or use in validation and monitoring sterilization processes. This document gives specific requirements for those biological indicators intended for use in dry heat sterilization processes.The ISO 11138 series represents the current “state-of-the-art” according to the experts representing manufacture

30、rs, 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 those biological indicators that are known to be in use today.A standard exi

31、sts providing general requirements for the validation and control of dry heat sterilization processeses (see ISO 20857).NOTE It is possible that some countries or regions have published other standards covering requirements for sterilization or biological indicators.Advice on selection, use and inte

32、rpretation of results when using biological indicators can be found in ISO 14161. ISO 2017 All rights reserved vBS EN ISO 11138-4:2017BS EN ISO 11138-4:2017Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilization processes1 ScopeThis docume

33、nt specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 C to 180 C.N

34、OTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.NOTE 2 Requirements for work place safety can be provided by national or regional regulations.2 Normative referencesThe following documents are referred to in the text in such a way that some

35、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 referenced document (including any amendments) applies.ISO 11138-1:2017, Sterilization of health care products Biological indicat

36、ors Part 1: General requirementsISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11138-1 apply.ISO and IEC maintain terminological databases for use in st

37、andardization 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/ 4 General requirementsThe requirements of ISO 11138-1 apply.5 Test organism5.1 The test organisms shall be spores of

38、 Bacillus atrophaeus or other strains of microorganisms of demonstrated equivalent performance as required by this document.NOTE 1 Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus.INTERNATIONAL STANDARD ISO 11138-4:2017(E) ISO 2017 All rights reserved 1BS EN ISO 11138-

39、4:2017ISO 11138-4:2017(E)NOTE 2 Bacillus atrophaeus CIP 77.18, NCIMB 8058, DSM 675, NRRL B-4418 and ATCC 9372 or Bacillus subtilis, DSM 13019 have been found to be suitable1).5.2 If a test organism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism shall

40、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 dry heat sterilization processes shall be demonstrated in accordance with the requirements of ISO 111

41、38-1:2017, 5.2 and Annex B.7.2 The exposure conditions to determine compliance shall be the following:a) minimum exposure temperature: greater than or equal to 5 C above the manufacturers stated maximum temperature;b) sterilizing agent: dry heat in ambient air;c) maximum exposure temperature: as sta

42、ted by the manufacturer; if not stated by the manufacturer, the maximum exposure temperature shall be greater than or equal to 180 C;d) exposure time: greater than or equal to 30 min.NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the

43、 practical limits of a dry heat sterilization process.8 Inoculated carriers and biological indicatorsThe requirements of ISO 11138-1 apply.9 Population and resistance9.1 The manufacturer shall state the resistance characteristics according to ISO 11138-1:2017, 6.4.9.2 The viable count shall be state

44、d with increments less than or equal to 0,1 10nper unit (e.g. per ml of suspension, 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 1,0 106.9.4 The resistance shall be expressed as the D val

45、ue in minute at 160 C. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 160 C.9.5 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D160value of not less than 2,

46、0 min when tested according to the conditions in Annex A. Other microorganisms shall have D values supporting the application. The z value of the test organisms in the suspension, on the inoculated carrier or in the biological indicator shall be determined at not less than 1) These are examples of s

47、uitable products available commercially. This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of these products.2 ISO 2017 All rights reservedBS EN ISO 11138-4:2017ISO 11138-4:2017(E)three temperatures, in the range of 150 C to 180 C.

48、These data shall be used to calculate the z value, which shall be greater than or equal to 20 C (see Annex B).9.6 The resistance characteristics specified in this document and any other document shall be defined using the specific critical variables associated with the referenced sterilization proce

49、ss.9.7 D values are determined according to methods given in ISO 11138-1:2017, Annexes C and D.9.8 Determination of D value and survival-kill response characteristics require the use of a resistometer applying the reference resistometer process parameters (see Annex A).NOTE The values stated above would fit a dry heat sterilizer with forced air distribution, running a cycle of 160 C with a holding time of 2 h.9.9 The survival-kill window should be calculated using the formulae in ISO 11138-1:2017, Annex E.N