《BS-EN-12180-2000.pdf》由会员分享,可在线阅读,更多相关《BS-EN-12180-2000.pdf(26页珍藏版)》请在三一文库上搜索。
1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12180:2000 The Euro
2、pean Standard EN 12180:2000 has the status of a British Standard ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Non-active surgical implants Body contouring implants Specific requirements for mammary implants Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 2
3、8 05:28:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 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 June 2000 BSI 06-2000 ISBN 0 580 34892 X BS E
4、N 12180:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN 12180:2000. The UK participation in its preparation was entrusted to Technical Committee CH/19, Reconstructive surgical implants, which has the
5、 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 o
6、rganizations 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 International Stan
7、dards Correspondence Index, or by using the Find 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
8、 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 2 to 22, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last
9、 issued. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI (8523($1?67$1$5 1250(?(8523e(11( (8523b,6&+(?1250 (1? )HEUXDU? ,&6? (QJOLVK?YHUVLRQ 1RQ?DFWLYH?VXUJLFDO?LPSODQWV?%RG?FRQWRXULQJ?LPSODQWV? 6SHFLILF?UHTXLUHPHQWV?IRU?PDPPDU?LPSODQWV ,PSO
10、DQWV?FKLUXUJLFDX?QRQ?DFWLIV?,PSODQWV?PRUSKRORJLTXHV ?(LJHQFHV?VSpFLILTXHV?UHODWLYHV?DX?LPSODQWV?PDPPDLUHV 1LFKWDNWLYH?FKLUXUJLVFKH?,PSODQWDWH?:HLFKWHLOLPSODQWDWH? %HVRQGHUH?$QIRUGHUXQJHQ?DQ?0DPPDLPSODQWDWH 7KLV?(XURSHDQ?6WDQGDUG?ZDV?DSSURYHG?E?&(1?RQ?2FWREHU? &(1?PHPEHUV?DUH?ERXQG?WR?FRPSO?ZLWK?WKH?
11、&(1?&(1(/(&?,QWHUQDO?5HJXODWLRQV?ZKLFK?VWLSXODWH?WKH?FRQGLWLRQV?IRU?JLYLQJ?WKLV?(XURSHDQ 6WDQGDUG?WKH?VWDWXV?RI?D?QDWLRQDO?VWDQGDUG?ZLWKRXW?DQ?DOWHUDWLRQ?8S?WR?GDWH?OLVWV?DQG?ELEOLRJUDSKLFDO?UHIHUHQFHV?FRQFHUQLQJ?VXFK?QDWLRQDO VWDQGDUGV?PD?EH?REWDLQHG?RQ?DSSOLFDWLRQ?WR?WKH?&HQWUDO?6HFUHWDULDW?RU?WR?
12、DQ?&(1?PHPEHU? 7KLV?(XURSHDQ?6WDQGDUG?HLVWV?LQ?WKUHH?RIILFLDO?YHUVLRQV?(QJOLVK?)UHQFK?*HUPDQ?$?YHUVLRQ?LQ?DQ?RWKHU?ODQJXDJH?PDGH?E?WUDQVODWLRQ XQGHU?WKH?UHVSRQVLELOLW?RI?D?&(1?PHPEHU?LQWR?LWV?RZQ?ODQJXDJH?DQG?QRWLILHG?WR?WKH?&HQWUDO?6HFUHWDULDW?KDV?WKH?VDPH?VWDWXV?DV?WKH?RIILFLDO YHUVLRQV? &(1?PHPEH
13、UV?DUH?WKH?QDWLRQDO?VWDQGDUGV?ERGLHV?RI?$XVWULD?%HOJLXP?&HFK?5HSXEOLF?HQPDUN?)LQODQG?)UDQFH?*HUPDQ?*UHHFH? ,FHODQG?,UHODQG?,WDO?/XHPERXUJ?1HWKHUODQGV?1RUZD?3RUWXJDO?6SDLQ?6ZHGHQ?6ZLWHUODQG?DQG?8QLWHG?.LQJGRP? (8523($1? &200,77(? )25? 67$1$5,=$7,21 &20,7e? (8523e(1? (? 1250$/,6$7,21 (8523b,6&+(6? .20
14、,7(? )h5? 125081* &HQWUDO?6HFUHWDULDW?UXH?GH?6WDVVDUW?%?%UXVVHOV ?&(1$OO?ULJKWV?RI?HSORLWDWLRQ?LQ?DQ?IRUP?DQG?E?DQ?PHDQV?UHVHUYHG ZRUOGZLGH?IRU?&(1?QDWLRQDO?0HPEHUV? 5HI?1R?(1?( Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3DJH? (1? ?%6,?
15、 &217(176 3DJH )RUHZRUG? ,QWURGXFWLRQ? ? ?6FRSH? ?1RUPDWLYH?UHIHUHQFHV? ?HILQLWLRQV? ? ?,QWHQGHG?SHUIRUPDQFH? ?HVLJQ?DWWULEXWHV? ? ?0DWHULDOV? ?HVLJQ?HYDOXDWLRQ? ?0DQXIDFWXULQJ? ? ?6WHULOLDWLRQ? ? ? 3DFNDJLQJ? ? ? ,QIRUPDWLRQ?VXSSOLHG?E?WKH?PDQXIDFWXUHU? $QQH?$?QRUPDWLYH?6XUIDFH?FKDUDFWHULVWLFV? $QQ
16、H?%?QRUPDWLYH?7HVWV?IRU?VKHOO?LQWHJULW? ? $QQH?&?QRUPDWLYH?7HVW?UHTXLUHPHQWV?IRU?YDOYH?FRPSHWHQFH?DQG?LQMHFWLRQ?VLWH?FRPSHWHQFH ? $QQH?QRUPDWLYH?7HVWV?IRU?VLOLFRQH?JHO?FRKHVLRQ? $QQH?(?QRUPDWLYH?0HFKDQLFDO?WHVWV?RQ?PDPPDU?LPSODQW?LQ?LWV?LPSODQWDEOH?VWDWH? ? $QQH?=$?LQIRUPDWLYH?&ODXVHV?RI?WKLV?(XURSH
17、DQ?6WDQGDUG?DGGUHVVLQJ?HVVHQWLDO UHTXLUHPHQWV?RU?RWKHU?SURYLVLRQV?RI?(8?LUHFWLYHV? ? %LEOLRJUDSK? ? Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3DJH? (1? ?%6,? )RUHZRUG 7KLV?(XURSHDQ?6WDQGDUG?KDV?EHHQ?SUHSDUHG?E?7HFKQLFDO?&RPPLWWHH?&(1?7
18、&?1RQ?DFWLYH VXUJLFDO?LPSODQWV?WKH?6HFUHWDULDW?RI?ZKLFK?LV?KHOG?E?11,? 7KLV?(XURSHDQ?6WDQGDUG?VKDOO?EH?JLYHQ?WKH?VWDWXV?RI?D?QDWLRQDO?VWDQGDUG?HLWKHU?E?SXEOLFDWLRQ?RI DQ?LGHQWLFDO?WHW?RU?E?HQGRUVHPHQW?DW?WKH?ODWHVW?E?$XJXVW?DQG?FRQIOLFWLQJ?QDWLRQDO VWDQGDUGV?VKDOO?EH?ZLWKGUDZQ?DW?WKH?ODWHVW?E?$XJXVW
19、? 7KLV?(XURSHDQ?6WDQGDUG?KDV?EHHQ?SUHSDUHG?XQGHU?D?PDQGDWH?JLYHQ?WR?&(1?E?WKH?(XURSHDQ &RPPLVVLRQ?DQG?WKH?(XURSHDQ?)UHH?7UDGH?$VVRFLDWLRQ?DQG?VXSSRUWV?HVVHQWLDO?UHTXLUHPHQWV?RI (8?LUHFWLYH?V? )RU?UHODWLRQVKLS?ZLWK?(8?LUHFWLYH?V?VHH?LQIRUPDWLYH?$QQH?=$?ZKLFK?LV?DQ?LQWHJUDO?SDUW?RI?WKLV VWDQGDUG? 7KHU
20、H?DUH?WKUHH?OHYHOV?RI?(XURSHDQ?6WDQGDUGV?GHDOLQJ?ZLWK?QRQ?DFWLYH?VXUJLFDO?LPSODQWV?7KHVH DUH?DV?IROORZV?ZLWK?/HYHO?EHLQJ?KLJKHVW? /HYHO?*HQHUDO?UHTXLUHPHQWV?IRU?QRQ?DFWLYH?VXUJLFDO?LPSODQWV? /HYHO?3DUWLFXODU?UHTXLUHPHQWV?IRU?IDPLOLHV?RI?QRQ?DFWLYH?VXUJLFDO?LPSODQWV? /HYHO?6SHFLILF?UHTXLUHPHQWV?IRU?W
21、SHV?RI?QRQ?DFWLYH?VXUJLFDO?LPSODQWV? 7KLV?LV?D?/HYHO?VWDQGDUG?DQG?FRQWDLQV?UHTXLUHPHQWV?WKDW?DSSO?WR?VSHFLILF?WSHV?RI?LPSODQWV ZLWKLQ?D?IDPLO? 7KH?/HYHO?VWDQGDUG?(1?,62?FRQWDLQV?UHTXLUHPHQWV?WKDW?DSSO?WR?DOO?QRQ?DFWLYH?VXUJLFDO LPSODQWV?,W?DOVR?LQGLFDWHV?WKDW?WKHUH?DUH?DGGLWLRQDO?UHTXLUHPHQWV?LQ?WKH
22、?/HYHO?DQG?/HYHO? VWDQGDUGV? 7KH?/HYHO?VWDQGDUGV?DSSO?WR?D?PRUH?UHVWULFWHG?VHW?RU?IDPLO?RI?LPSODQWV?VXFK?DV?WKRVH?GHVLJQHG IRU?XVH?LQ?RVWHRVQWKHVLV?FDUGLRYDVFXODU?VXUJHU?RU?MRLQW?UHSODFHPHQW? /HYHO?VWDQGDUGV?FRQWDLQ?UHTXLUHPHQWV?WKDW?DSSO?WR?DOO?QRQ?DFWLYH?VXUJLFDO?LPSODQWV?LQ?SDUWLFXODU IDPLOLHV?RI
23、?LPSODQWV? 127(?$?/HYHO?VWDQGDUG?RQ?ERG?FRQWRXULQJ?LPSODQWV?LV?FXUUHQWO?LQ?SUHSDUDWLRQ? 7R?DGGUHVV?DOO?UHTXLUHPHQWV?LW?LV?QHFHVVDU?WR?VWDUW?ZLWK?D?VWDQGDUG?RI?WKH?ORZHVW?DYDLODEOH?OHYHO? 5HIHUHQFHV?WR?RWKHU?(XURSHDQ?RU?LQWHUQDWLRQDO?VWDQGDUGV?FDQ?DOVR?EH?IRXQG?LQ?WKH?%LEOLRJUDSK $FFRUGLQJ?WR?WKH?&(1
24、?&(1(/(&?,QWHUQDO?5HJXODWLRQV?WKH?QDWLRQDO?VWDQGDUGV?RUJDQLDWLRQV?RI WKH?IROORZLQJ?FRXQWULHV?DUH?ERXQG?WR?LPSOHPHQW?WKLV?(XURSHDQ?6WDQGDUG?$XVWULD?%HOJLXP?&HFK 5HSXEOLF?HQPDUN?)LQODQG?)UDQFH?*HUPDQ?*UHHFH?,FHODQG?,UHODQG?,WDO?/XHPERXUJ? 1HWKHUODQGV?1RUZD?3RUWXJDO?6SDLQ?6ZHGHQ?6ZLWHUODQG?DQG?WKH?8QLW
25、HG?.LQJGRP? Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3DJH? (1? ?%6,? ,QWURGXFWLRQ 7KLV?(XURSHDQ?6WDQGDUG?SURYLGHV?LQ?DGGLWLRQ?WR?WKH?UHTXLUHPHQWV?LQ?WKH?/HYHO?DQG?/HYHO? VWDQGDUGV?D?PHWKRG?WR?GHPRQVWUDWH?FRPSOLDQFH?ZLWK?WKH?UHOHYDQW?(
26、VVHQWLDO?5HTXLUHPHQWV?(5V? DV?RXWOLQHG?LQ?JHQHUDO?WHUPV?LQ?$QQH?,?RI?WKH?&RXQFLO?LUHFWLYH?(&?RI?-XQH? FRQFHUQLQJ?PHGLFDO?GHYLFHV?DV?WKH?DSSO?WR?ERG?FRQWRXULQJ?LPSODQWV?VSHFLILFDOO?PDPPDU LPSODQWV?IRU?XVH?LQ?FOLQLFDO?SUDFWLFH? ?6FRSH 7KLV?VWDQGDUG?GHVFULEHV?VSHFLILF?UHTXLUHPHQWV?IRU?PDPPDU?LPSODQWV?I
27、RU?FOLQLFDO?SUDFWLFH? :LWK?UHJDUG?WR?VDIHW?LW?JLYHV?UHTXLUHPHQWV?IRU?LQWHQGHG?SHUIRUPDQFH?GHVLJQ?DWWULEXWHV? PDWHULDOV?GHVLJQ?HYDOXDWLRQ?PDQXIDFWXULQJ?VWHULOLDWLRQ?SDFNDJLQJ?DQG?LQIRUPDWLRQ?VXSSOLHG?E WKH?PDQXIDFWXUHU? 127(?$W?WKH?WLPH?RI?SXEOLFDWLRQ?RI?WKLV?GRFXPHQW?IRU?HQTXLU?VHYHUDO?WHVW?PHWKRGV?
28、VSHFLILHG?LQ?WKH?DQQHHV?ZHUH EHLQJ?YDOLGDWHG?)RU?WKH?WLPH?EHLQJ?ZKHUH?DSSURSULDWH?GLVFORVXUH?VWDWHPHQWV?DUH?LQFOXGHG?LQ?WKHVH?DQQHHV? ?1RUPDWLYH?UHIHUHQFHV 7KLV?(XURSHDQ?6WDQGDUG?LQFRUSRUDWHV?E?GDWHG?RU?XQGDWHG?UHIHUHQFH?SURYLVLRQV?IURP?RWKHU SXEOLFDWLRQV?7KHVH?QRUPDWLYH?UHIHUHQFHV?DUH?FLWHG?DW?WKH?
29、DSSURSULDWH?SODFHV?LQ?WKH?WHW?DQG?WKH SXEOLFDWLRQV?DUH?OLVWHG?KHUHDIWHU?)RU?GDWHG?UHIHUHQFHV?VXEVHTXHQW?DPHQGPHQWV?WR?RU?UHYLVLRQV?RI DQ?RI?WKHVH?SXEOLFDWLRQV?DSSO?WR?WKLV?(XURSHDQ?6WDQGDUG?RQO?ZKHQ?LQFRUSRUDWHG?LQ?LW?E DPHQGPHQW?RU?UHYLVLRQ?)RU?XQGDWHG?UHIHUHQFHV?WKH?ODWHVW?HGLWLRQ?RI?WKH?SXEOLFDWL
30、RQ?UHIHUUHG?WR DSSOLHV? (1?,62?1RQ?DFWLYH?VXUJLFDO?LPSODQWV?*HQHUDO?UHTXLUHPHQWV?,62? 1)?7?9XOFDQLHG?RU?WKHUPRSODVWLF?UXEEHU?7HQVLOH?WHVW 1)?7?9XOFDQLHG?UXEEHUV?HWHUPLQDWLRQ?RI?WHDU?VWUHQJWK?DQJOH?WHDU?WHVW?SLHFH ZLWK?RU?ZLWKRXW?QLFN?DQG?FUHVFHQW?WHVW?SLHFH? 1)?6?0HGLFDO?GHYLFHV?6LOLFRQH?HODVWRPHU?R
31、I?PHGLFDO?JUDGH 127(?7KH?%LEOLRJUDSK?JLYHV?LQIRUPDWLYH?UHIHUHQFHV?WR?RWKHU?XVHIXO?VWDQGDUGV? Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3DJH? (1? ?%6,? ?HILQLWLRQV )RU?WKH?SXUSRVHV?RI?WKLV?VWDQGDUG?WKH?GHILQLWLRQV?LQ?(1?,62?DSSO?WRJHWKH
32、U?ZLWK?WKH IROORZLQJ? ?PDPPDU?LPSODQW?,PSODQW?GHVLJQHG?WR?DGG?WR?RU?UHSODFH?YROXPH?RI?WKH?EUHDVW? ?VKHOO?(QYHORSH?RI?WKH?LPSODQW? ?VHDPV?RU?VHDOV?-XQFWLRQ?RI?PDWHULDOV?IXVHG?RU?DGKHUHG?WRJHWKHU? ?YDOYH?&RPSRQHQW?LQWR?ZKLFK?DQ?DFFHVVRU?LV?LQVHUWHG?WR?LQIODWH?YDULDEOH?YROXPH?LPSODQWV? ?LQMHFWLRQ?VLWH?
33、&RPSRQHQW?GHVLJQHG?WR?EH?SHQHWUDWHG?E?D?QHHGOH?WR?DOWHU?WKH?YROXPH?RI?WKH LPSODQW? ?GLIIXVLRQ?0RYHPHQW?RI?PDWHULDO?RXW?RI?DQ?LPSODQW?WKURXJK?DQ?LQWDFW?VKHOO? ?EDVH?GLPHQVLRQV?/HQJWK?RI?WKH?PDMRU?DLV?DQG?WKH?OHQJWK?RI?WKH?PLQRU?DLV?ZKHQ?WKH?LPSODQW LV?SODFHG?ZLWK?LWV?EDVH?RQ?D?IODW?KRULRQWDO?VXUIDFH?
34、DW?LWV?QRPLQDO?YROXPH? ?DQWHULRU?SURMHFWLRQ?0DLPXP?KHLJKW?RI?WKH?LPSODQW?ZKHQ?SODFHG?ZLWK?LWV?EDVH?RQ?D?IODW KRULRQWDO?VXUIDFH?DW?LWV?QRPLQDO?YROXPH? ?RULHQWDWLRQ?PHDQV?0DUN?LQ?RU?RQ?WKH?LPSODQW?WR?DVVLVW?WKH?VXUJHRQ?WR?SRVLWLRQ?WKH?LPSODQW? ?,QWHQGHG?SHUIRUPDQFH 7KH?UHTXLUHPHQWV?RI?FODXVH?RI?(1?,62
35、?DSSO? ?HVLJQ?DWWULEXWHV 7KH?UHTXLUHPHQWV?RI?FODXVH?RI?(1?,62?DSSO? ?0DWHULDOV 7KH?UHTXLUHPHQWV?RI?FODXVH?RI?(1?,62?DSSO?,Q?DGGLWLRQ?LI?VLOLFRQH?HODVWRPHU?LV XVHG?1)?6?DSSOLHV? 6SHFLDO?DWWHQWLRQ?VKDOO?EH?JLYHQ?WR?WKH?ELRORJLFDO?HYDOXDWLRQ?RI?WKH?GHYLFH?DQG?LWV?FRPSRQHQWV IROORZLQJ?LPSODQW?IDLOXUH? 1
36、27(?7KH?ELRORJLFDO?HYDOXDWLRQ?VKRXOG?EH?LQ?DFFRUGDQFH?ZLWK?WKH?SULQFLSOHV?VHW?RXW?LQ?(1?,62? Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3DJH? (1? ?%6,? ?HVLJQ?HYDOXDWLRQ 7KH?UHTXLUHPHQWV?RI?FODXVH?RI?(1?,62?DSSO? ?3UH?FOLQLFDO?HYDOXDWLR
37、Q 7KH?SUH?FOLQLFDO?HYDOXDWLRQ?RI?PDPPDU?LPSODQWV?VKDOO?FRQIRUP?WR?RI?(1?,62? 127(?:LWK?UHJDUG?WR?YDOLGDWHG?WHVW?PHWKRGV?DYDLODEOH?IRU?WKH?SUH?FOLQLFDO?HYDOXDWLRQ?WKLV?VWDQGDUG?UHIOHFWV?WKH SUHVHQW?VWDWH?RI?WKH?DUW?7HVWV?IRU?WKH?HYDOXDWLRQ?RI?DEUDVLRQ?RI?PDPPDU?LPSODQWV?DQG?IRU?WKH?HYDOXDWLRQ?RI?JHO
38、EOHHGLQJ?RI?PDPPDU?LPSODQWV?LQ?YLWUR?DUH?FXUUHQWO?XQGHU?GHYHORSPHQW?$V?VRRQ?DV?DFFHSWDEOH?DQG?YDOLGDWHG?WHVW PHWKRGV?DUH?DYDLODEOH?WKHVH?ZLOO?EH?FRQVLGHUHG?IRU?LQFOXVLRQ?LQ?WKLV?VWDQGDUG?E?DQ?DPHQGPHQW?RU?UHYLVLRQ? 7KH?VDPSOH?VLH?VHOHFWHG?VKDOO?EH?EDVHG?RQ?D?VWDWLVWLFDO?UDWLRQDOH?ZKLFK?VKDOO?EH?MXVW
39、LILHG?DQG GRFXPHQWHG?,Q?DGGLWLRQ?WKH?IROORZLQJ?VKDOO?EH?DGGUHVVHG?ZKHUH?DSSOLFDEOH? 127(?:KHUH?DSSURSULDWH?IRU?PDWHULDOV?RWKHU?WKDQ?VLOLFRQH?WKH?PDQXIDFWXUHU?VKRXOG?FRQVLGHU?DQG?GHYHORS WHVWV?DV?LQGLFDWHG?LQ? ?6KHOO?LQWHJULW 7KH?LQWHJULW?RI?WKH?VKHOO?VKDOO?EH?HYDOXDWHG? 7KH?LQWHJULW?RI?WKH?VLOLFRQH?
40、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