BS EN 868-8-1999 经消毒医疗设备用包装材料和系统.符合EN 285的蒸汽消毒器用可重复使用的消毒容器.要求和试验方法.pdf
《BS EN 868-8-1999 经消毒医疗设备用包装材料和系统.符合EN 285的蒸汽消毒器用可重复使用的消毒容器.要求和试验方法.pdf》由会员分享,可在线阅读,更多相关《BS EN 868-8-1999 经消毒医疗设备用包装材料和系统.符合EN 285的蒸汽消毒器用可重复使用的消毒容器.要求和试验方法.pdf(12页珍藏版)》请在三一文库上搜索。
1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 868-8:1999 The Euro
2、pean Standard EN 868-8:1999 has the status of a British Standard ICS 11.080.30; 55.120; NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Packaging materials and systems for medical devices which are to be sterilized Part 8: Re-usable sterilization containers for steam sterilize
3、rs conforming to EN 285 Requirements and test methods Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:59:18 BST 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemical
4、s, was published under the authority of the Standards Committee and comes into effect on 15 November 1999 BSI 11-1999 ISBN 0 580 35317 6 BS EN 868-8:1999 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the English language version of EN 868-8:1999.
5、 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 responsible European comm
6、ittee 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 to its secretary. Cross-r
7、eferences 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 Standards Electronic Catal
8、ogue. 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 (see Annex ZA of EN 868-
9、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 Standard does not purport to
10、 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, an inside front cover,
11、the EN title page, pages 2 to 9 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 21:59:18 BST 2006, Uncontrolled Copy, (c) BSI CEN European Committe
12、e 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 868-8:1999 E EUROPEAN STANDARD
13、EN 868-8 NORME EUROPE ENNE EUROPA ISCHE NORM June 1999 ICS 11.080; 55.040; 55.120 English version Packaging materials and systems for medical devices which are to be sterilized Part8: Re-usable sterilization containers for steam sterilizers conforming to EN285 Requirements and test methods Mate riau
14、x et syste mes demballages pour les dispositifs me dicaux devant e tre ste rilise s Partie 8: Conteneurs re utilisables de ste rilisation pour ste rilisateurs a la vapeur deau conformes a lEN 285 Exigences et me thodes dessai Verpackungsmaterialien und -systeme fu r zu sterilisierende Medizinprodukt
15、e Teil 8: Wiederverwendbare Sterilisierbeha lter fu r Dampf-Sterilisatoren nach EN285 Anforderungen und Pru fverfahren This 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 E
16、uropean 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 Central Secretariat or to any CEN member. This European Standard exists in three official versions (Engl
17、ish, 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 the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Repu
18、blic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:59:18 BST 2006, Uncontrolled Copy, (c) BSI Page
19、 2 EN 868-8:1999 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 Standard shall be given the status of a national standard, either by publication of an identical
20、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 concerned with packaging materials and systems for medical devices which are to be sterilized. This ser
21、ies 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 and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirement
22、s 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 manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods. EN 868-4, Pac
23、kaging 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 be sterilized Part 5: Heat and self sealable pouches and reels of paper and plastic film constructi
24、on 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 ethylene oxide or irradiation Requirements and test methods. EN 868-7, Packaging materials and sy
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- BS EN 868-8-1999 经消毒医疗设备用包装材料和系统.符合EN 285的蒸汽消毒器用可重复使用的消毒容器.要求和试验方法 868 1999 消毒 医疗 备用 包装材料 系统 符合 285 蒸汽
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