DIN EN ISO 11140-1-2015 Sterilization of health care products - Chemical indicators - Part 1 General requirements (ISO 11140-1 2014) German version EN ISO 11140-1 2014《医疗保健产品灭菌 化学指.pdf

1、March 2015 Translation by DIN-Sprachendienst.English price group 17No 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、11.080.20!%AR=“2304726www.din.deDDIN EN ISO 11140-1Sterilization of health care products Chemical indicators Part 1: General requirements (ISO 11140-1:2014);English version EN ISO 11140-1:2014,English translation of DIN EN ISO 11140-1:2015-03Sterilisation von Produkten fr die Gesundheitsfrsorge Chem

3、ische Indikatoren Teil 1: Allgemeine Anforderungen (ISO 11140-1:2014);Englische Fassung EN ISO 11140-1:2014,Englische bersetzung von DIN EN ISO 11140-1:2015-03Strilisation des produits de sant Indicateurs chimiques Partie 1: Exigences gnrales (ISO 11140-1:2014);Version anglaise EN ISO 11140-1:2014,T

4、raduction anglaise de DIN EN ISO 11140-1:2015-03SupersedesDIN EN ISO 11140-1:2009-09www.beuth.deDocument comprises 42 pagesIn case of doubt, the German-language original shall be considered authoritative.03.15 DIN EN ISO 11140-1:2015-03 2 A comma is used as the decimal marker. National foreword This

5、 document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was

6、 the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-08 AA Indikatoren. Users of this standard should take note of the following: During the revision of this standard, the German mirror committee to ISO/TC 198/WG 6 expressed its concerns several times rega

7、rding the technical feasibility of the requirements specified for Type 6 indicators. According to the standard, a Type 6 indicator is to be capable of responding to a temperature difference of 1 K (0,5 C). However, this means that there cannot be any variation in the cycle, or that the measurement a

8、ccuracy of the test device (resistometer) must be greater than 0,5 K, the accuracy currently required in the standard for resistometers, EN ISO 18472. In order to obtain significant results when testing the performance of a Type 6 indicator, the resistometer thus has to have a considerably greater a

9、ccuracy. Furthermore, the equipment used to calibrate such a resistometers would also have to have a greater accuracy. It is not sensible to specify requirements for an indicator type when there are no suitable methods of establishing compliance with those requirements. For this reason, the German m

10、irror committee recommends that users of this standard critically examine any claims on the part of manufacturers of Type 6 indicators that their product meets these specific requirements. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on m

11、edical devices. DIN EN ISO 11140 consists of the following parts, under the general title Sterilization of health care products Chemical indicators: Part 1: General requirements Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test Part 4: Class 2 indicators as

12、an alternative to the Bowie and Dick-type test for detection of steam penetration NOTE ISO 11140-2 has been replaced by EN ISO 18472. ISO 11140-5 has not been adopted by CEN as an EN ISO Standard. The DIN Standards corresponding to the International Standards referred to in this document are as foll

13、ows: ISO 8601 DIN ISO 8601 ISO 9001 DIN EN ISO 9001 ISO 11135 DIN EN ISO 11135 (all parts) ISO 11137 DIN EN ISO 11137 (all parts) ISO 11138 DIN EN ISO 11138 (all parts) ISO 11140-3 DIN EN ISO 11140-3 ISO 11140-4 DIN EN ISO 11140-4 ISO 11607 DIN EN ISO 11607 (all parts) ISO 13485 DIN EN ISO 13485 DIN

14、 EN ISO 11140-1:2015-03 3 ISO 14161 DIN EN ISO 14161 ISO 15882 DIN EN ISO 15882 ISO 17665 DIN EN ISO 17665 (all parts) ISO 18472 DIN EN ISO 18472 ISO/IEC 17025 DIN EN ISO/IEC 17025 ISO/IEC 17050-1 DIN EN ISO/IEC 17050-1 Amendments This standard differs from DIN EN ISO 11140-1:2009-09 as follows: a)

15、Clause 4 “Categorization” has been rendered more precise; it has been clarified that the categorizations have no hierarchical significance and “Class ” has been changed to “Type ”; b) normative references and the Bibliography have been updated; c) “3.10 process parameter” has been added and the form

16、er terms “variable” and “penetration” have been deleted; d) Table 1 “Categories according to intended use” has been included in Clause 4; e) performance requirements for Type 5 indicators (Subclause 4.6 and Clause 11) have been redefined; f) performance requirements for Type 6 indicators (Subclause

17、4.7 and Clause 12) have been rendered more precise; g) requirements for information to be supplied by the manufacturer (Subclause 5.8) have been revised; h) test methods and performance requirements for process indicators for steam, EO and vaporized hydrogen peroxide (e.g. test duration and temperat

18、ure, Tables 1, 3, 6 and 8) have been revised; i) test methods and performance requirements for Type 5 indicators (Table 9) have been supplemented; j) requirements for integrating indicators (Type 5) for dry heat sterilisation have been deleted; k) the sterilisation temperature for emulating indicato

19、rs (Type 6) has been changed; l) in Annex B, the example of testing integrating (Type 5) indicators has been deleted; m) Annex C providing rationale for the requirements for integrating indicators has been revised; n) Annex ZA (informative) concerning the relationship between this European Standard

20、and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating

21、 to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN 867-1: 1997-05 DIN EN 867-2: 1997-05 DIN EN ISO 11140-1: 2006-04, 2009-09 DIN EN ISO 11140-1 Corrigendum 1: 2007-10 DIN EN ISO

22、11140-1:2015-03 4 National Annex NA (informative) Bibliography DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 11135 (all parts), Sterilization of health care products Ethylene oxide DIN EN ISO 11137 (all parts), Sterilization of health care products Radiation DIN EN ISO 11138 (a

23、ll parts), Sterilization of health care products Biological indicators DIN EN ISO 11140-3, Sterilization of health care products Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test DIN EN ISO 11140-4, Sterilization of health care products C

24、hemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration DIN EN ISO 11607 (all parts), Packaging for terminally sterilized medical devices DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulator

25、y purposes DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results DIN EN ISO 15882, Sterilization of health care products Chemical indicators Guidance for selection, use and interpretation of results DIN EN ISO 1766

26、5 (all parts), Sterilization of health care products Moist heat DIN EN ISO 18472, Sterilization of health care products Biological and chemical indicators Test equipment DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories DIN EN ISO/IEC 17050-1, Conf

27、ormity assessment Supplier s declaration of conformity Part 1: General requirements DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11140-1 November 2014 ICS 11.080.01 Supersedes EN

28、 ISO 11140-1:2009English Version Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) Strilisation des produits de sant - Indicateurs chimiques -Partie 1: Exigences gnrales (ISO 11140-1:2014) Sterilisation von Produkten fr die Gesundheitsfrsor

29、ge - Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2014) This European Standard was approved by CEN on 23 August 2014. 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 na

30、tional 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 official versions (English, French, German). A v

31、ersion 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 Austria, Belgium, Bulgaria, Croatia, Cyprus

32、, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingd

33、om. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 1114

34、0-1:2014 EContents PageForeword 4Introduction 51 Scope 62 Normative references . 63 Terms and definitions 74 Categorization 94.1 General 94.2 Type 1: process indicators . 94.3 Type 2: indicators for use in specific tests 104.4 Type 3: single critical process variable indicators . 104.5 Type 4: multi

35、critical process variable indicators 104.6 Type 5: integrating indicators 104.7 Type 6: emulating indicators 105 General requirements . 106 Performance requirements . 136.1 General . 136.2 Type 1 indicators. 146.3 Type 2 indicators. 146.4 Types 3, 4, 5 and 6 indicators . 147 Test methods . 147.1 Gen

36、eral . 147.2 Off-set (transference) 147.3 Procedure Steam indicators . 147.4 Procedure Dry heat indicators . 157.5 Procedure EO indicators . 157.6 Procedure Low temperature steam and formaldehyde indicators .167.7 Procedure Vaporized hydrogen peroxide indicators 168 Additional requirements for proce

37、ss (Type 1) indicators 178.1 Process indicators printed or applied on to packaging material .178.2 Process indicators for steam sterilization processes .178.3 Process indicators for dry heat sterilization processes .178.4 Process indicators for ethylene oxide sterilization processes .188.5 Process i

38、ndicators for radiation sterilization processes .188.6 Process indicators for low temperature steam and formaldehyde sterilization processes 198.7 Process indicators for vaporized hydrogen peroxide sterilization processes199 Additional requirements for single critical process variable (Type 3) indic

39、ators 2010 Additional requirements for multicritical process variable (Type 4) indicators .2011 Additional requirements for steam integrating (Type 5) indicators .2112 Additional requirements for ethylene oxide integrating (Type 5) indicators .2213 Additional requirements for emulating (Type 6) indi

40、cators .22Annex A (normative) Method for demonstrating shelf-life of the product 24Annex B (informative) Examples of testing indicators 25Annex C (informative) Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators specified in ISO 11138

41、(all parts) and microbial inactivation .27DIN EN ISO 11140-1:2015-03 EN ISO 11140-1:2014 (E) 2 formaldehyde indicators .34Annex E (informative) Relationship of indicator and indicator system components 35Bibliography 38DIN EN ISO 11140-1:2015-03 EN ISO 11140-1:2014 (E) 3Annex ZA (informative) Relati

42、onship between this European Standard and the Essential Requirements of EU Directive 93/42/EC on medical devicesAnnex D (informative) Rationale for the liquid-phase test method for low temperature steam and 36.Foreword This document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/

43、TC 198 “Sterilization of health care products“ in collaboration 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 en

44、dorsement, at the latest by May 2015, and conflicting national standards shall be withdrawn at the latest by May 2015. 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 identifyin

45、g any or all such patent rights. This document supersedes EN ISO 11140-1:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s

46、), 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 implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denm

47、ark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement no

48、tice The text of ISO 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification. DIN EN ISO 11140-1:2015-03 EN ISO 11140-1:2014 (E) 4 IntroductionThis part of ISO 11140 specifies performance requirements and/or test methods for chemical indicators intended for use with sterilization processes emplo