BS EN ISO 11140-1-2014 Sterilization of health care products Chemical indicators General requirements《保健产品的灭菌 化学指示剂 一般要求》.pdf

1、BSI Standards PublicationBS EN ISO 11140-1:2014Sterilization of health careproducts Chemical indicatorsPart 1: General requirementsBS EN ISO 11140-1:2014Incorporating corrigendum January 2015BS EN ISO 11140-1:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN

2、ISO 11140-1:2014. It supersedes BS EN ISO 11140-1:2009 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publi

3、cation does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 89220 2ICS 11.080.01Compliance with a British Standard cannot confer immunit

4、y from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2014.Amendments/corrigenda issued since publicationDate Text affected31 January 2015 Implementation of CEN Correction Notice 10 December 2014. Table ZA.1 fir

5、st column updatedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11140-1 November 2014 ICS 11.080.01 Supersedes EN 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

6、- Indicateurs chimiques -Partie 1: Exigences gnrales (ISO 11140-1:2014) Sterilisation von Produkten fr die Gesundheitsfrsorge - 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 wi

7、th 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 references concerning such national standards may be obtained on application to the CEN-CENELEC Mana

8、gement 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 CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same st

9、atus 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 Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Mal

10、ta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, 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 2014 CE

11、N All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11140-1:2014 EBS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 3 Foreword This document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of heal

12、th 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 endorsement, at the latest by M

13、ay 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 identifying any or all such patent righ

14、ts. 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), see informative Annex ZA,

15、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, Denmark, Estonia, Finland, Former

16、 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 notice The text of ISO 11140-1:

17、2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 3 Foreword This document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Comm

18、ittee 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 May 2015, and conflicting national standards shall be w

19、ithdrawn 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 identifying any or all such patent rights. This document supersedes EN ISO 11140-1:2009. This

20、 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), see informative Annex ZA, which is an integral part of this document. According

21、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, Germany, Gree

22、ce, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 w

23、ithout any modification. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 3 Foreword his 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” the

24、 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 May 2015, and conflicting national standards shall be withdrawn at the latest by May 2015. Attention is drawn

25、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 document supersedes EN ISO 11140-1:2009. This document has been prepared under a mandate given to CE

26、N by the European Commission and the European Free Trade Association, 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 s

27、tandards 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, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania

28、, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification. BS EN ISO 11140-1:2014EN ISO 1

29、1140-1:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to

30、provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance w

31、ith the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Dir

32、ective 93/42/EC on medical devices Clause(s)/sub-clause(s) of this prEN ISO 11140-1 Essential Requirements (ERs) of Directive 93/42/EC Qualifying remarks/Notes 5.9 6.2.2 6.4.2 7.2 7.2 release of toxic substances transfer type 1 transfer type. 3 6 test procedure 5.8 g) 5.8 h) 6.2.2 7.3, 1stpart Inter

33、fering substances Safety precautions required during and/or after use Bleed and offset 4.1; 4.2; 5; 6.1; 6.2; 7; 8 8.7 type 1 indicator 5.8 13.1 Instructions for use 5.6, 5.7 13.2 Symbols 5.4, 5.6, 5.7, 5.8 i), 5.8 k) 4 5.2 13.3 a), b) Labelling Classification of indicators Critical variables and st

34、ated values 5.8 j) 13.3 c) Labelling 5.4, 5.6, 5.7, 5.8 i), 5.8 k) 4 5.2 13.3 d) Labelling Classification of indicators Critical variables and stated values 5.8 j) 13.3 e), f), g), h) Labelling, expiry date. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 4 Annex ZA (informative) Relationship between

35、this European Standard and the Essential Requirements of EU Directive 93/42/EC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the

36、 New Approach Directive 93/42/EC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers,

37、within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EC on medical devices Clause(s)/sub-clause(s) of

38、this prEN ISO 11140-1 Essential Requirements (ERs) of Directive 93/42/EC Qualifying remarks/Notes 5.9 6.2.2 6.4.2 7.2 7.2 release of toxic substances transfer type 1 transfer type. 3 6 test procedure 5.8 g) 5.8 h) 6.2.2 7.3, 1stpart Interfering substances Safety precautions required during and/or af

39、ter use Bleed and offset 4.1; 4.2; 5; 6.1; 6.2; 7; 8 8.7 type 1 indicator 5.8 13.1 Instructions for use 5.6, 5.7 13.2 Symbols 5.4, 5.6, 5.7, 5.8 i), 5.8 k) 4 5.2 13.3 a), b) Labelling Classification of indicators Critical variables and stated values 5.8 j) 13.3 c) Labelling 5.4, 5.6, 5.7, 5.8 i), 5.

40、8 k) 4 5.2 13.3 d) Labelling Classification of indicators Critical variables and stated values 5.8 j) 13.3 e), f), g), h) Labelling, expiry date. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 3 Foreword This document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 “Steriliz

41、ation 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 endorsement, at th

42、e 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 identifying any or all suc

43、h 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), see informati

44、ve 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, Denmark, Estonia, Fi

45、nland, 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 notice The text of

46、 ISO 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification. BS EN ISO 11140-1:2014EN ISO 11140-1:2014 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EC on medical devices This European Stan

47、dard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EC on medical devi es. Once this standard is cited in the Official Journal of the Euro

48、pean Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requir

49、ements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EC on medical devices Clause(s)/sub-clause(s) of this prEN ISO 11140-1 Essential Requirements (ERs) of Directive 93/42/EC Qualifying remarks/Notes 5.9 6.2.2 6.4.2 7.2 7.2 release of toxic substances transfer type 1 transfer type. 3 6 test procedure 5.8 g) 5.8 h) 6.2.2 7.3, 1stpart Interfering substances Safety precautions required during and/or after use Bleed and offset 4.1; 4.2; 5; 6.1; 6.2; 7; 8 8.7 type 1 indicator 5.8 1