BS-EN-ISO-11607-1-2006.pdf
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1、BRITISH STANDARD BS EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems The European Standard EN ISO 11607-1:2006 has the status of a British Standard ICS 11.080.30 ? BS EN ISO 11607-1:2006 This Bri
2、tish Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2006 BSI 2006 ISBN 0 580 48311 8 National foreword This British Standard is the official English language version of EN ISO 11607-1:2006. It is identical with ISO 11607-1:2006. It supersedes BS E
3、N 868-1:1997 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-re
4、ferences The 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 Brit
5、ish Standards 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. aid enquirers to understand the text; presen
6、t to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside
7、 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 25 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments E
8、UROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11607-1 April 2006 ICS 11.080.30Supersedes EN 868-1:1997 English Version Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) Emballages des d
9、ispositifs mdicaux striliss au stade terminal - Partie 1: Exigences relatives aux matriaux, aux systmes de barrire strile et aux systmes demballage (ISO 11607-1:2006) Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme
10、 und Verpackungssysteme (ISO 11607-1:2006) This European Standard was approved by CEN on 13 April 2006. 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.
11、 Up-to-date lists and bibliographical references concerning such national standards 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 translation
12、under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
13、 Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: r
14、ue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11607-1:2006: E Foreword This document (EN ISO 11607-1:2006) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health ca
15、re 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 Octob
16、er 2006, and conflicting national standards shall be withdrawn at the latest by April 2007. This document supersedes EN 868-1:1997. 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
17、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 standards organizations of the following countries are bound to implement this European Standard: Austria, Bel
18、gium, Cyprus, Czech Republic, 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
19、ISO 11607-1:2006 has been approved by CEN as EN ISO 11607-1:2006 without any modifications. EN ISO 11607-1:2006 Reference number ISO 11607-1:2006(E) INTERNATIONAL STANDARD ISO 11607-1 First edition 2006-04-15 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, ste
20、rile barrier systems and packaging systems Emballages des dispositifs mdicaux striliss au stade terminal Partie 1: Exigences relatives aux matriaux, aux systmes de barrire strile et aux systmes demballage EN ISO 11607-1:2006 ii iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative ref
21、erences. 1 3 Terms and definitions. 1 4 General requirements. 5 4.1 General. 5 4.2 Quality systems 5 4.3 Sampling 6 4.4 Test methods. 6 4.5 Documentation 6 5 Materials and preformed sterile barrier systems 7 5.1 General requirements. 7 5.2 Microbial barrier properties. 9 5.3 Compatibility with the s
22、terilization process. 10 5.4 Compatibility with the labelling system . 10 5.5 Storage and transport 10 6 Design and development requirements for packaging systems. 11 6.1 General. 11 6.2 Design 11 6.3 Packaging-system performance testing. 12 6.4 Stability testing. 12 7 Information to be provided 13
23、Annex A (informative) Guidance on medical packaging 14 Annex B (informative) Standardized test methods and procedures that may be used to demonstrate compliance with the requirements of this part of ISO 11607 17 Annex C (normative) Test method for resistance of impermeable materials to the passage o
24、f air 21 Bibliography. 22 EN ISO 11607-1:2006 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices 25 iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of natio
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