BS-EN-ISO-10993-11-2006.pdf
《BS-EN-ISO-10993-11-2006.pdf》由会员分享,可在线阅读,更多相关《BS-EN-ISO-10993-11-2006.pdf(38页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity The European Standard EN ISO 10993-11:2006 has the status of a British Standard ICS 11.100.20 ? Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:36:13 GMT+00:00 2006, Uncon
2、trolled Copy, (c) BSI BS EN ISO 10993-11:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 September 2006 BSI 2006 ISBN 0 580 49253 2 National foreword This British Standard was published by BSI. It is the UK implementation of EN ISO 10
3、993-11:2006. It supersedes BS EN ISO 10993-11:1996 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices. A list of organizations represented on CH/194 can be obtained on request to its secretary. This public
4、ation does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun shef
5、fieldun, na, Sat Nov 18 01:36:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-11 August 2006 ICS 11.100.20 Supersedes EN ISO 10993-11:1995 English Version Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO
6、 10993-11:2006) valuation biologique des dispositifs mdicaux - Partie 11: Essais de toxicit systmique (ISO 10993-11:2006) Biologische Beurteilung von Medizinprodukten - Teil 11: Prfungen auf systemische Toxizitt (ISO 10993-11:2006) This European Standard was approved by CEN on 7 August 2006. CEN mem
7、bers 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 references concerning such national standards may be obtained on applicat
8、ion 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 under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the
9、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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
10、 Slovakia, Slovenia, 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 2006 CEN All rights of exploitation in any form and by any means reserved wo
11、rldwide for CEN national Members. Ref. No. EN ISO 10993-11:2006: E Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:36:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document supersedes EN ISO 10993-11:1995. This document has been prepared under a mandate given to CEN by the Eu
12、ropean Commission and the According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
13、Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 10993-11:2006 has been approved by CEN as EN ISO 10993-11:2006 without any modifications. This d
14、ocument (EN ISO 10993-11:2006) has been prepared by Technical Committee 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 European St
15、andard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2007, and conflicting national standards shall be withdrawn at the latest by February 2007. European Free Trade Association, and supports essential require
16、ments of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. EN ISO 10993-11:2006 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:36:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 10993-11:2006(E)
17、 INTERNATIONAL STANDARD ISO 10993-11 Second edition 2006-08-15 Biological evaluation of medical devices Part 11: Tests for systemic toxicity valuation biologique des dispositifs mdicaux Partie 11: Essais de toxicit systmique EN ISO 10993-11:2006 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18
18、 01:36:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:36:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction. vi 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 General considerations
19、2 4.1 General. 2 4.2 Selection of animal species. 3 4.3 Animal status 3 4.4 Animal care and husbandry. 3 4.5 Size and number of groups . 3 4.6 Route of exposure 4 4.7 Sample preparation 4 4.8 Dosing 5 4.9 Body weight and food/water consumption 6 4.10 Clinical observations 6 4.11 Clinical pathology.
20、6 4.12 Anatomic pathology . 7 4.13 Study designs . 7 4.14 Quality of investigation 7 5 Acute systemic toxicity 7 5.1 General. 7 5.2 Study design . 8 5.3 Evaluation criteria. 9 5.4 Final report 10 6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity) 11 6.1 Genera
21、l. 11 6.2 Study design . 12 6.3 Evaluation criteria. 14 6.4 Final report 15 Annex A (informative) Routes of administration. 16 Annex B (informative) Dosage volumes. 18 Annex C (informative) Common clinical signs and observations. 19 Annex D (informative) Suggested haematology, clinical chemistry and
22、 urinalysis measurements. 20 Annex E (informative) Suggested organ list for histopathological evaluation 22 Annex F (informative) Information on material-mediated pyrogens. 24 Bibliography. 26 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Dir
23、ectives 90/385/EC and 93/42/EEC 27 EN ISO 10993-11:2006 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:36:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member b
24、odies). 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 been established has the right to be represented on that committee. International organizations, governmental a
- 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 11 2006
链接地址:https://www.31doc.com/p-3745262.html