BS EN 868-3-1999 Packaging materials and systems for medical devices which are to be.pdf
《BS EN 868-3-1999 Packaging materials and systems for medical devices which are to be.pdf》由会员分享,可在线阅读,更多相关《BS EN 868-3-1999 Packaging materials and systems for medical devices which are to be.pdf(12页珍藏版)》请在三一文库上搜索。
1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 868-3:1999 The Euro
2、pean Standard EN 868-3:1999 has the status of a British Standard ICS 11.080.30; 55.040; NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Packaging materials and systems for medical devices which are to be sterilized Part 3: Paper for use in the manufacture of paper bags (specif
3、ied in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the
4、 direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 November 1999 BSI 11-1999 ISBN 0 580 35316 8 BS EN 868-3:1999 Amendments issued since publication Amd. No.DateComments National foreword This Briti
5、sh Standard is the English language version of EN 868-3:1999. It supersedes most of the normative text of BS 6256:1989, which is subject to amendment to this effect. BS 6256:1989 is not yet withdrawn, because reference is made to it in annex D of EN 868-1:1997, with reference to the possibility of a
6、pplying the methylene blue particulate penetration test (described in appendix C of BS 6256) as a means of assessing the microbial barrier properties of some types of sterilization packaging covered by EN 868. The UK participation in its preparation was entrusted by Technical Committee LBI/35, Steri
7、lizers, autoclaves and disinfectors, to Subcommittee LBI/35/9, Sterilization packaging materials, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interes
8、ts informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications refe
9、rred to in this document may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. Sterilization packaging materials falling within the scope of EN 868-1 are considered
10、 to be medical devices under Directive 93/42/EEC and compliance with the requirements of EN 868-1 is a means of ensuring that particular essential requirements of the Directive are met (see annex ZA of EN 868-1). This part of EN 868 may be used to demonstrate compliance with some of the requirements
11、 of Part 1. However, compliance with this part of EN 868 alone may not necessarily be considered to ensure that the essential requirements of the Directive have been met. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are respons
12、ible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 8, an inside back cover and a back cover. The BSI copyright n
13、otice displayed in this document indicates when the document was last issued. Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches
14、 Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 868-3:1999 E EUROPEAN STANDARDEN 868-3 NORME EUROPE ENNE EUROPA ISCHE NORM June 1999 ICS 11.080; 55
15、.040 English version Packaging materials and systems for medical devices which are to be sterilized Part3:Paper for use in the manufacture of paper bags (specified in EN868-4) and in the manufacture of pouches and reels (specified in EN868-5) Requirements and test methods Mate riaux et syste mes dem
16、ballages pour les dispositifs me dicaux devant e tre ste rilise s Partie 3: Papier utilise dans la fabrication de sacs en papier (spe cifie s dans lEN 868-4) et dans la fabrication de sachets et gaines (spe cifie s dans lEN 868-5) Exigences et me thodes dessai Verpackungsmaterialien und -systeme fu
17、r zu sterilisierende Medizinprodukte Teil 3: Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schla uchen (festgelegt in EN868-5) Anforderungen und Pru fverfahren This European Standard was approved by CEN on 13 May 1999. CEN members are
18、 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 application to t
19、he 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 same sta
20、tus 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, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: London South B
21、ank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI Page 2 EN 868-3:1999 BSI 11-1999 Foreword This European Standard has been prepared by Technical Committee CEN/TC 102, Sterilizers for medical purposes, the Secretariat of which is held by DIN. This
22、 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 December 1999, and conflicting national standards shall be withdrawn at the latest by December 1999. This standard is one of a series of European Standa
23、rds concerned with packaging materials and systems for medical devices which are to be sterilized. This series consists of the following parts. EN 868-1, Packaging materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods. EN 868-2, Packaging
24、materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methods. EN 868-3, Packaging materials and systems for medical devices which are to be sterilized Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and i
- 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 868-3-1999 Packaging materials and systems for medical devices which are to be 868 1999
链接地址:https://www.31doc.com/p-3648600.html