/home/gencode/overflow/cen/w455p1/455 1 19824 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |[.]
Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012 BRITISH STANDARD Medical gloves for single use Ð Part 1: Requirements and testing for freedom from holes The European Standard EN 455-1:2000 has the status of a British Standard ICS 11.140 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BS EN 455-1:2000 Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012 BS EN 455-1:2000 National foreword This British Standard is the official English language version of EN 455-1:2000 It supersedes BS EN 455-1:1994 which is withdrawn The UK participation in its preparation was entrusted to Technical Committee CH/6, Rubber products for hospital use, which has the responsibility to: Ð aid enquirers to understand the text; Ð present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; Ð monitor related international and European developments and promulgate them in the UK A list of organizations represented on this committee can be obtained on request to 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 ªInternational Standards Correspondence Indexº, or by using the ªFindº facility of the BSI Standards Electronic Catalogue 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 pages This document comprises a front cover, an inside front cover, the EN title page, pages to and a back cover The BSI copyright notice displayed in this document indicates when the document was last issued This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 December 2000 BSI 12-2000 ISBN 580 36697 Amendments issued since publication Amd No Date Comments (1 Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012 (8523($167$1'$5' 1250((8523e(11( (8523b,6&+(1250 2FWREHU ,&6 6XSHUVHGHV(1 (QJOLVKYHUVLRQ 0HGLFDOJORYHVIRUVLQJOHXVH3DUW5HTXLUHPHQWVDQGWHVWLQJ IRUIUHHGRPIURPKROHV *DQWVPpGLFDX[QRQUpXWLOLVDEOHV3DUWLH'p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e (8523e(1 '( 1250$/,6$7,21 (8523b,6&+(6 20,7(( )h5 125081* &HQWUDO6HFUHWDULDWUXHGH6WDVVDUW%%UXVVHOV &(1 $OOULJKWVRIH[SORLWDWLRQLQDQ\IRUPDQGE\DQ\PHDQVUHVHUYHG ZRUOGZLGHIRU&(1QDWLRQDO0HPEHUV 5HI1R(1( Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012 3DJH (1 )RUHZRUG 7KLV(XURSHDQ6WDQGDUGKDVEHHQSUHSDUHGE\7HFKQLFDO&RPPLWWHH&(17&1RQDFWLYHPHGLFDOGHYLFHVWKH 6HFUHWDULDWRIZKLFKLVKHOGE\%6, 7KLV(XURSHDQ6WDQGDUGVXSHUVHGHV(1 7KLV(XURSHDQ6WDQGDUGVKDOOEHJLYHQWKHVWDWXVRIDQDWLRQDOVWDQGDUGHLWKHUE\SXEOLFDWLRQRIDQLGHQWLFDOWH[WRU E\ HQGRUVHPHQW DW WKH ODWHVW E\ $SULO DQG FRQIOLFWLQJ QDWLRQDO VWDQGDUGV VKDOO EH ZLWKGUDZQ DW WKH ODWHVW E\ $SULO 7KLV(XURSHDQ6WDQGDUGKDVEHHQSUHSDUHGXQGHUDPDQGDWHJLYHQWR&(1E\WKH(XURSHDQ&RPPLVVLRQDQGWKH (XURSHDQ)UHH7UDGH$VVRFLDWLRQDQGVXSSRUWVHVVHQWLDOUHTXLUHPHQWVRI(8'LUHFWLYHV )RUUHODWLRQVKLSZLWK(8'LUHFWLYHVVHHLQIRUPDWLYH$QQH[=$ZKLFKLVDQLQWHJUDOSDUWRIWKLVVWDQGDUG 7KLV (XURSHDQ 6WDQGDUG DSSOLHV WR PHGLFDO JORYHV IRU VLQJOH XVH DQG KDV EHHQ SUHSDUHG LQ WKUHH SDUWV 7KLV SDUW DGGUHVVHVIUHHGRPIURPKROHV3DUWDGGUHVVHVSK\VLFDOSURSHUWLHVDQG3DUWDGGUHVVHVUHTXLUHPHQWVDQGWHVWLQJ IRUELRORJLFDOHYDOXDWLRQ $FFRUGLQJ WR WKH &(1&(1(/(& ,QWHUQDO 5HJXODWLRQV WKH QDWLRQDO VWDQGDUGV RUJDQL]DWLRQV RI WKH IROORZLQJ FRXQWULHV DUH ERXQG WR LPSOHPHQW WKLV (XURSHDQ 6WDQGDUG $XVWULD %HOJLXP &]HFK 5HSXEOLF 'HQPDUN )LQODQG )UDQFH *HUPDQ\ *UHHFH ,FHODQG ,UHODQG ,WDO\ /X[HPERXUJ 1HWKHUODQGV 1RUZD\ 3RUWXJDO 6SDLQ 6ZHGHQ 6ZLW]HUODQGDQGWKH8QLWHG.LQJGRP 6FRSH 7KLVSDUWRIWKLVVWDQGDUGVSHFLILHVUHTXLUHPHQWVDQGJLYHVWKHWHVWPHWKRGIRUPHGLFDOJORYHVIRUVLQJOHXVHLQRUGHU WRGHWHUPLQHIUHHGRPIURPKROHV 127($WWHQWLRQ LV GUDZQ WR (1 3URWHFWLYH JORYHV DJDLQVW FKHPLFDOV DQG PLFURRUJDQLVPV ±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icensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution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±DUHIHUHQFHWRWKLVSDUWRI(1 ±WKHW\SHRIJORYHVDQGPDQXIDFWXULQJEDWFKFRGH ±WKHQDPHDQGDGGUHVVRIWKHPDQXIDFWXUHURUGLVWULEXWRUDQGWHVWODERUDWRU\LIGLIIHUHQW ±WKHGDWHRIWKHWHVWSHUIRUPHG ±WKHWHVWUHVXOWVEDWFKVL]HVDPSOHVL]HQXPEHURIQRQFRQIRUPLQJJORYHV %6, Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012 3DJH (1 'LPHQVLRQVLQPLOOLPHWUHV H\ D &XIIHQGRIJORYH E /RFNLQJGHYLFH F )LOOWXEHRYHUODSSLQJ )LJXUH:DWHUWLJKWQHVVWHVW)LOOLQJWXEH %6, Licensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution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icensed copy: University of Auckland Library, University of Auckland Library, Version correct as of 21/05/2012 10:33, (c) The British Standards Institution 2012 BS EN 455-1:2000 BSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BSI Ð British Standards Institution BSI is the independent national body responsible for preparing British Standards It presents the UK view on standards in Europe and at the international level It is incorporated by Royal Charter Revisions British Standards are updated by amendment or revision Users of British Standards should make sure that they possess the latest amendments or editions It is the constant aim of BSI to improve the quality of our products and services We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover Tel: 020 8996 9000 Fax: 020 8996 7400 BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards Buying standards Orders for all BSI, international and foreign standards publications should be addressed to Customer Services Tel: 020 8996 9001 Fax: 020 8996 7001 In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as British Standards, unless otherwise requested Information on standards BSI provides a wide range of information on national, European and international standards through its Library and its Technical Help to Exporters Service Various BSI electronic information services are also available which give details on all its products and services Contact the Information Centre Tel: 020 8996 7111 Fax: 020 8996 7048 Subscribing members of BSI are kept up to date with standards developments and receive substantial discounts on the purchase price of standards For details of these and other benefits contact Membership Administration Tel: 020 8996 7002 Fax: 020 8996 7001 Copyright Copyright subsists in all BSI publications BSI also holds the copyright, in the UK, of the publications of the international standardization bodies Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means ± electronic, photocopying, recording or otherwise ± without prior written permission from BSI This does not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained If permission is granted, the terms may include royalty payments or a licensing agreement Details and advice can be obtained from the Copyright Manager Tel: 020 8996 7070