【BS英国标准】BS EN 868-2-1999 Packaging materials and systems for medical devices which are to be.doc
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1、BRITISH STANDARDPackaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methodsThe European Standard EN 868-2:1999 has the status of aBritish StandardICS 11.080.30; 55.040;| BS EN868-2:1999|Licensed Copy: London South Bank Unive
2、rsity, London South Bank University, Wed Jul 12 21:50:13 BST 2006, Uncontrolled Copy, (c) BSI|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 868-2:1999National forewordThis British Standard is the English language version of EN 868-2:1999. It supersedesBS 6254:1989 and B
3、S 6255:1989, which are withdrawn.The UK participation in its preparation was entrusted by Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, to Subcommittee LBI/35/9,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; present
4、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 obtained on re
5、quest 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 facility of the BS
6、I 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 Directive are m
7、et (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 met.A British Sta
8、ndard 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 comprises a front cover, a
9、n inside front cover, the EN title page, pages 2 to 11 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 21:50:13 BST 2006, Uncontrolled Copy, (c) BSIA
10、md. 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 35311 7Amendments issued since publicatio
11、nEUROPEAN STANDARDEN 868-2NORME EUROPE ENNEEUROPA ISCHE NORMJune 1999ICS 11.080.30; 55.040English versionPackaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methodsMate riaux et syste mes demballages pour les dispositifs me
12、dicaux devant e tre ste rilise s Partie 2: Enveloppes de ste rilisation Exigences et me thodes dessaiVerpackungsmaterialien und -systeme fu r zu sterilisierende Medizinprodukte Teil 2: Sterilisierverpackung Anforderungen und Pru fverfahrenLicensed Copy: London South Bank University, London South Ban
13、k University, Wed Jul 12 21:50:13 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 standard
14、 without any alteration. 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 langua
15、ge made by translation 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Ice
16、land, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.CENEuropean Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r NormungCentral Secretariat: rue de Stassart 36, B-1050 Brussels1999 CEN All rights of
17、exploitation in any form and by any means reserved worldwide for CEN nationalMembers.Ref. No. EN 868-2:1999 EPage 9EN 868-2:1999BSI 11-1999ForewordThis European Standard has been prepared byTechnical Committee CEN/TC 102, Sterilizers forContentsPageLicensed Copy: London South Bank University, London
18、 South Bank University, Wed Jul 12 21:50:13 BST 2006, Uncontrolled Copy, (c) BSImedical purposes, the Secretariat of which is held byDIN.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest byDecember 199
19、9, and conflicting national standards shall be withdrawn at the latest by December 1999.This standard is one of a series of European Standards concerned with packaging materials and systems for medical devices which are to be sterilized. This series of European Standards consists of the following pa
20、rts: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 materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methods.EN 868-3, Pack
21、aging 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 inEN 868-5) Requirements and test methods.EN 868-4, Packaging materials and systems for med
22、ical devices which are to be sterilized Part 4: Paper bags Requirements and test methods.EN 868-5, Packaging materials and systems for medical devices which are to be sterilized Part 5: Heat and self sealable pouches and reels of paper and plastic film construction Requirements and test methods.EN 8
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