【BS英国标准】BS EN 868-9-2000 消毒医疗装置和包装材料.用于生产热密封袋,卷轴和盖的聚烯烃非包覆非织物材料.要求和试验方法.doc

british standardpackaging materials and systems for medical devices which are to be sterilized part 9: uncoated nonwoven materials of polyolefines for use in the manufactureof heat sealable pouches, reels and lids requirements and test methodsthe european standard en 868-9:2000 has the status of abritish standardics 11.080.30| bs en868-9:2000|licensed copy: london south bank university, london south bank university, wed jul 12 21:59:51 bst 2006, uncontrolled copy, (c) bsi|no copying without bsi permission except as permitted by copyright lawbs en 868-9:2000national forewordthis british standard is the official english language version of en 868-9:2000. the uk participation in its preparation was entrusted by technical committeelbi/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 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 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 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 the 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 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 comprises a front cover, an inside front cover, the en title page, pages 2 to 8, an inside back cover 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 21:59:51 bst 2006, uncontrolled 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 july 2000bsi 07-2000isbn 0 580 36076 8amendments issued since publication(8523($1 67$1$51250( (8523e(11( (8523b,6&+( 1250(1 )heuxdu ,&6 (qjolvk yhuvlrq3dfndjlqj pdwhuldov dqg vvwhpv iru phglfdo ghylfhv zklfk duh wr eh vwhulolhg 3duw 8qfrdwhg qrqzryhq pdwhuldov risrorohilqhv iru xvh lq wkh pdqxidfwxuh ri khdw vhdodeohsrxfkhv uhhov dqg olgv 5htxluhphqwv dqg whvw phwkrgv0dwpuldx hw vvwqphv ghpedoodjhv srxu ohv glvsrvlwliv ppglfdx ghydqw rwuh vwpulolvpv 3duwlh 1rq wlvvpv j edvh gh sroropilqhv qrq hqgxlwv srxu od ideulfdwlrq gh vdfkhwv jdlqhv hw rshufxohv wkhuprvfhoodeohv (ljhqfhv hw ppwkrghv ghvvdl9husdfnxqjvpdwhuldolhq xqg vvwhph iu x vwhulolvlhuhqgh0hgllqsurgxnwh 7hlo 8qehvfklfkwhwh 9olhvvwriih dxv3rorohilqhq iu glh +huvwhooxqj yrq khlvlhjhoilkljhq.oduvlfkwehxwhoq vfkolxfkhq xqg ghfnhoq $qirughuxqjhq xqg 3uiyhuidkuhq7klv (xurshdq 6wdqgdug zdv dssuryhg e &(1 rq hfhpehu &(1 phpehuv duh erxqg wr frpso zlwk wkh &(1 &(1(/(& ,qwhuqdo 5hjxodwlrqv zklfk vwlsxodwh wkh frqglwlrqv iru jlylqj wklv 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