BS EN 868-6-1999 Packaging materials and systems for medical devices which are to be.pdf
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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 868-6:1999 The Euro
2、pean Standard EN 868-6:1999 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 6: Paper for the manufacture of packs for medical use for
3、 sterilization by ethylene oxide or irradiation Requirements and test methods Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:58:27 BST 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector Committee fo
4、r 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 35313 3 BS EN 868-6:1999 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the English language v
5、ersion 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 the text; present to the r
6、esponsible 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 request t
7、o 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 facility of the BSI St
8、andards 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 met
9、(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 met. A British Stan
10、dard 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 comprises a front cover,
11、 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, Uncontrolled Copy, (c) B
12、SI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches 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 868-6:
13、1999 E EUROPEAN STANDARDEN 868-6 NORME EUROPE ENNE EUROPA ISCHE NORM June 1999 ICS 11.080; 55.040 English version Packaging materials and systems for medical devices which are to be sterilized Part6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiatio
14、n Requirements and test methods Mate 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 et me thodes dessai Verpackungsmateria
15、lien 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 fverfahren This European Standard was approved by CEN on 13 May 1999. CEN members are bound to
16、 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 the Centra
17、l 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 status as th
18、e 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 Bank Unive
19、rsity, London South Bank University, Wed Jul 12 21:58:27 BST 2006, Uncontrolled Copy, (c) BSI Page 2 EN 868-6:1999 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 European
20、 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 Standards conce
21、rned 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 materials
22、 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 in the man
23、ufacture of pouches and reels (specified in EN 868-5) Requirements and test methods. EN 868-4, Packaging materials and systems for medical 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 b
24、e sterilized Part 5: Heat and self sealable pouches and reels of paper and plastic film construction Requirements and test methods. EN 868-6, Packaging 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
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