BS-EN-ISO-11137-3-2006.pdf
《BS-EN-ISO-11137-3-2006.pdf》由会员分享,可在线阅读,更多相关《BS-EN-ISO-11137-3-2006.pdf(28页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 11137-3:2006 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects The European Standard EN ISO 11137-3:2006 has the status of a British Standard ICS 11.080.01 ? Licensed Copy: London South Bank University, London South Bank University, Sat
2、 Mar 17 03:49:47 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 11137-3:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 March 2007 BSI 2007 ISBN 978 0 580 50366 5 National foreword This British Standard was published by BSI. It
3、is the UK implementation of EN ISO 11137-3:2006. It supersedes BS EN 552:1994, which will be withdrawn on 1 April 2009. The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices. A list of organizations represented on CH/198 can be obtained
4、 on request to its secretary. 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 cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. Dat
5、eComments Licensed Copy: London South Bank University, London South Bank University, Sat Mar 17 03:49:47 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11137-3 April 2006 ICS 11.080.01Supersedes EN 552:1994 English Version Sterilization of health
6、care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) Strilisation des produits de sant - Irradiation - Partie 3: Directives relatives aux aspects dosimtriques (ISO 11137- 3:2006) Sterilisation von Produkten fr die Gesundheitsfrsorge - Strahlen - Teil 3: Anleitung zu
7、dosimetrischen Aspekten (ISO/FDIS 11137-3:2006) 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 altera
8、tion. 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 transla
9、tion 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, Hun
10、gary, 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 Cent
11、re: rue 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 11137-3:2006: E Licensed Copy: London South Bank University, London South Bank University, Sat Mar 17 03:49:47 GMT+00:00 2007, Uncontro
12、lled Copy, (c) BSI Foreword This document (EN ISO 11137-3:2006) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 204 “Sterilization of medical devices“, the secretariat of which is held by BSI. This European
13、Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2006, and conflicting national standards shall be withdrawn at the latest by April 2009. This document supersedes EN 552:1994. This document has been prep
14、ared 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 to the CEN/CENELEC Inte
15、rnal 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Nethe
16、rlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11137-3:2006 has been approved by CEN as EN ISO 11137-3:2006 without any modifications. EN ISO 11137-3:2006 Licensed Copy: London South Bank University, Lo
17、ndon South Bank University, Sat Mar 17 03:49:47 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 11137-3:2006(E) INTERNATIONAL STANDARD ISO 11137-3 First edition 2006-04-15 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects Strilisation des produits
18、 de sant Irradiation Partie 3: Directives relatives aux aspects dosimtriques EN ISO 11137-3:2006 Licensed Copy: London South Bank University, London South Bank University, Sat Mar 17 03:49:47 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank
19、 University, Sat Mar 17 03:49:47 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 Measurement of dose. 1 5 Selection and calibration of dosimetry systems. 2 5.1 General. 2 5.2 Selection of dosim
20、etry systems 2 5.3 Calibration of dosimetry system. 2 6 Establishing the maximum acceptable dose. 2 7 Establishing the sterilization dose 3 8 Installation qualification. 4 9 Operational qualification 4 9.1 General. 4 9.2 Gamma irradiators 5 9.3 Electron beam irradiators 6 9.4 X-ray irradiators 7 10
21、Performance qualification 8 10.1 General. 8 10.2 Gamma and X-ray . 9 10.3 Electron beam . 10 11 Routine monitoring and control 11 11.1 General. 11 11.2 Frequency of dose measurements . 11 Annex A (informative) Mathematical modelling 12 Bibliography. 15 EN ISO 11137-3:2006 Relationship between this E
22、uropean Standard and the Essential Requirements of EU Directives 90/385/EEC concerning active implantable medi medical devices and 98/79/EEC concerning in vitro diagnostic medical devices Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directiv
23、es 90/385/EEC concerning active implantable medical devices, 93/42/EEC concerning medical devices and 98/79/EEC concerning in vitro diagnostic medical devices.16 Licensed Copy: London South Bank University, London South Bank University, Sat Mar 17 03:49:47 GMT+00:00 2007, Uncontrolled Copy, (c) BSI
24、iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which
- 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 11137 2006
链接地址:https://www.31doc.com/p-3747070.html