《【BS英国标准】BS EN 86831999 Packaging materials and systems for medical devices which are to be》由会员分享，可在线阅读，更多相关《【BS英国标准】BS EN 86831999 Packaging materials and systems for medical devices which are to be（13页珍藏版）》请在金锄头文库上搜索。
1、BRITISH STANDARDPackaging 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 in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methodsThe European Standard EN 868-
2、3:1999 has the status of aBritish StandardICS 11.080.30; 55.040;| BS EN868-3:1999|Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 868-3:1999
3、National forewordThis British 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 BS 6256:1989 is not yet withdrawn, because reference is made to it inannex D of EN 868-1:1997, with referen
4、ce to the possibility of applying 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 Technica
5、l 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; present to the responsible European committee any enquiries on the interpretation, or proposals for change
6、, 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 obtained on request to its secretary.Cross-referencesThe British Standards which implement international or Euro
7、pean 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 theFind facility of the BSI Standards Electronic Catalogue.Sterilization packaging materials falling within the scope of EN
8、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 Directive are met (see annex ZA of EN 868-1). This part ofEN 868 may be used to demonstrate compliance with some
9、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 met.A British Standard does not purport to include all the necessary provisions of a contract. Users of British Sta
10、ndards are responsible for their correct application.Compliance with a British Standard does not of itself confer immunity from legal obligations.Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSIThis British Standard,
11、having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the StandardsCommittee and comes into effect on 15 November 1999BSI 11-1999ISBN 0 580 35316 8Summary of pagesThis document comprises a front cover, an inside front cover
12、, the EN title page, pages 2 to 8, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amd. No.DateCommentsAmendments issued since publicationEUROPEAN STANDARDEN 868-3NORME EUROPE ENNEEUROPA ISCHE NORMJune 1999ICS 11.0
13、80; 55.040English versionPackaging materials and systems for medical devices which are to be sterilized Part 3: Paper for use in themanufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methodsMate riaux et syste m
14、es demballages 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 danslEN 868-5) Exigences et me thodes dessaiVerpackungsmaterialien und -systeme
