【BS英国标准】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.doc
《【BS英国标准】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.doc》由会员分享,可在线阅读,更多相关《【BS英国标准】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.doc(13页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARDPackaging materials and systems for medical devices which are to be sterilized Part 8: Re-usable sterilization containers for steam sterilizers conforming toEN 285 Requirements and test methodsThe European Standard EN 868-8:1999 has the status of aBritish StandardICS 11.080.30; 55.12
2、0;| BS EN868-8:1999|Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:59:18 BST 2006, Uncontrolled Copy, (c) BSI|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 868-8:1999National forewordThis British Standard is the English language
3、 version of EN 868-8:1999.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
4、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 request t
5、o 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 BSI Stand
6、ards 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 (see
7、 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 Standard d
8、oes 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, an insid
9、e front cover, 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) BSIAmd. No.D
10、ateCommentsThis 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 35317 6Amendments issued since publicationEUROPEA
11、N STANDARDEN 868-8NORME EUROPE ENNEEUROPA ISCHE NORMJune 1999ICS 11.080; 55.040; 55.120English versionPackaging materials and systems for medical devices which are to be sterilized Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 Requirements and test methodsMate
12、 riaux 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 dessaiVerpackungsmaterialien und -systeme fu r zu sterilisierende Medizinpro
13、dukte Teil 8: Wiederverwendbare Sterilisierbeha lter fu r Dampf-Sterilisatoren nach EN 285 Anforderungen und Pru fverfahrenLicensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:59:18 BST 2006, Uncontrolled Copy, (c) BSIThis European Standard was approved by CEN on
14、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 without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be o
15、btained 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 language made by translation under the responsibility of a CEN member into its own language and notified to the Central Se
16、cretariat 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, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.CENEu
17、ropean 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 exploitation in any form and by any means reserved worldwide for CEN nationalMembers.Ref. No. EN 868-8:1999 EPage 9E
18、N 868-8:1999BSI 11-1999ForewordThis European Standard has been prepared byTechnical Committee CEN/TC 102, Sterilizers forContentsPageLicensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:59:18 BST 2006, Uncontrolled Copy, (c) BSImedical purposes, the Secretariat of
19、 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 1999, and conflicting national standards shall be withdrawn at the latest by December 1999.This standard is one of a se
20、ries of European Standards concerned 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
21、.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, Packaging materials and systems for medical devices which are to be sterilized Part 3: Paper for use in the manufacture of paper bags (specifie
22、d in EN 868-4) and in the manufacture 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 med
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- BS英国标准 【BS英国标准】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 BS 英国 标准 868 1999 消毒
链接地址:https://www.31doc.com/p-3620460.html