BS-EN-ISO-10993-10-2002.pdf
《BS-EN-ISO-10993-10-2002.pdf》由会员分享,可在线阅读,更多相关《BS-EN-ISO-10993-10-2002.pdf(62页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 10993-10:2002 Incorporating Corrigendum No. 1 and Amendment No. 1 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity The European Standard EN ISO 10993-10:2002, with the incorporation of amendment A1:2006, has the statu
2、s of a British Standard ICS 11.100 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-10:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee,
3、was published under the authority of the Standards Policy and Strategy Committee on 8 October 2002 BSI 2006 ISBN 0 580 40508 7 National foreword This British Standard is the official English language version of EN ISO 10993-10:2002, including amendment A1:2006. It is identical with ISO 10993-10:2002
4、, including amendment 1:2006. It supersedes BS EN ISO 10993-10:1996 which is withdrawn. The start and finish of text introduced or altered by ISO amendment is indicated in the text by tags !“. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO
5、 amendment 1 is indicated by !“. The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-re
6、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
7、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. In particular the attention of users is draw
8、n to legal requirements stipulated in the Animals (Scientific Procedures) Act 1986. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related internat
9、ional and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to vi, pages 1 to 49, the Annex ZA page, the Annex ZB page and a back cover. The
10、 BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 14275 Corrigendum No. 1 20 December 2002Corrected EN ISO foreword page and incorporating the Annex ZB page. 1658329 September 2006See national forewor
11、d Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-10 September 2002 ICS 11.100Supersedes EN ISO 10993-10:1995 English version Biological evaluation of medical devices - Part 10:
12、Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) Evaluation biologique des dispositifs mdicaux - Partie 10: Essais dirritation et dhypersensibilit retarde (ISO 10993- 10:2002) Biologische Beurteilung von Medizinprodukten - Teil 10: Prfung auf Irritation und Allergien vom ve
13、rzgerten Typ (ISO 10993-10:2002) This European Standard was approved by CEN on 5 August 2002. 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-dat
14、e lists and bibliographical references concerning such national standards may be obtained on application to the 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 re
15、sponsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Ma
16、lta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CENAll rights of exploitation in any form and by any mea
17、ns reserved worldwide for CEN national Members. Ref. No. EN ISO 10993-10:2002 E +A1 July 2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:44 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CORRECTED 2002-11-27 Foreword This document (EN ISO 10993-10:2002) has been prepared by Technical C
18、ommittee ISO/TC 194 “Biological evaluation of medical devices“ in collaboration with Technical Committee CEN/TC 206 “Biocompatibility of medical and dental materials and devices“, the secretariat of which is held by NEN. This document supersedes EN ISO 10993-10:1995. This European Standard shall be
19、given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2003, and conflicting national standards shall be withdrawn at the latest by March 2003. For relationship with EU Directive(s), see informative Annex ZB, which is an integral
20、 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
21、Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10993-10:2002 has been approved by CEN as EN ISO 10993-10:2002 without any modifications. NOTE Normative references to International Standards are listed in Annex ZA (normative
22、). EN ISO 1099310:2002 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). This document (EN ISO 10993-10:2002/A1:2006) has been prepared by Technical Committee ISO/TC
23、 194 “Biological evaluation of medical devices“ in collaboration with Technical Committee CEN/TC 206 “Biocompatibility of medical and dental materials and devices“, the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication
24、 of an identical text or by endorsement, at the latest by January 2007, and conflicting national standards shall be withdrawn at the latest by January 2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports e
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- BS EN ISO 10993 10 2002
链接地址:https://www.31doc.com/p-3746460.html