《BS EN 868-10-2000 消毒医疗装置和包装材料.用于生产热密封袋,卷轴和盖的聚烯烃胶粘包覆非织物材料.要求和试验方法.pdf》由会员分享,可在线阅读,更多相关《BS EN 868-10-2000 消毒医疗装置和包装材料.用于生产热密封袋,卷轴和盖的聚烯烃胶粘包覆非织物材料.要求和试验方法.pdf(16页珍藏版)》请在三一文库上搜索。
1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 868-10:2000 The Eur
2、opean Standard EN 868-10:2000 has the status of a British Standard ICS 11.080.30 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Packaging materials and systems for medical devices which are to be sterilized Part 10: Adhesive coated nonwoven materials of polyolefines for use i
3、n the manufacture of heat sealable pouches, reels and lids Requirements and test methods Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 22:00:24 BST 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector C
4、ommittee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 July 2000 BSI 07-2000 ISBN 0 580 36075 X BS EN 868-10:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official E
5、nglish language version of EN 868-10:2000. The UK participation in its preparation was entrusted by Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, to Subcommittee LBI/35/9, Sterilization packaging materials, which has the responsibility to: aid enquirers to understand the text
6、; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subcommittee can be obt
7、ained on request to its secretary. Cross-references The British Standards which implement international or European publications referred 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 faci
8、lity of the BSI Standards Electronic Catalogue. Sterilization packaging materials falling within the scope of EN 868-1 are considered 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
9、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 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 m
10、et. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document compri
11、ses a front cover, an inside front cover, the EN title page, pages 2 to 12, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 22
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