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1、BRITISH STANDARDPackaging materials and systems for medical devices which are to be sterilized Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation Requirements and test methodsThe European Standard EN 868-6:1999 has the status of aBritish Sta
2、ndardICS 11.080.30; 55.040;| BS EN868-6:1999|Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:58:27 BST 2006, Uncontrolled Copy, (c) BSI|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 868-6:1999National forewordThis British Standar
3、d is the English language version of EN 868-6:1999.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
4、the text; 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
5、 be obtained on request to its secretary.Cross-referencesThe 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 theFind
6、facility 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 t
7、he Directive are met (see Annex ZA of EN 868-1). This Part ofEN 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
8、 met.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 pagesThis document comprise
9、s a front cover, an inside front cover, the EN title page, pages 2 to 7 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 21:58:27 BST 2006, Uncontroll
10、ed Copy, (c) BSIAmd. No.DateCommentsThis British Standard, 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 35313 3Amendments issued
11、 since publicationEUROPEAN STANDARDEN 868-6NORME EUROPE ENNEEUROPA ISCHE NORMJune 1999ICS 11.080; 55.040English versionPackaging materials and systems for medical devices which are to be sterilized Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irra
12、diation Requirements and test methodsMate riaux et syste mes demballages pour les dispositifs me dicaux devant e tre ste rilise s Partie 6: Papier pour la fabrication demballages a usage me dical pour ste rilisation par loxyde dethyle ne ou par irradiation Exigences etme thodes dessaiVerpackungsmate
13、rialien und -systeme fu r zu sterilisierende Medizinprodukte Teil 6: Papier fu r die Herstellung von Verpackungen fu r medizinische Zwecke zur Sterilisation mit Ethylenoxid oder Strahlen Anforderungen und Pru fverfahrenLicensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:58:27 BST 2006, Uncontrolled Copy, (c) BSIThis European Standard was approved by CEN on 13 May 1999.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
