1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 13091:2000 The Euro
2、pean Standard EN 13091:1999 has the status of a British Standard ICS 07.080; 07.100.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Biotechnology Performance criteria for filter elements and filtration assembliesThis British Standard, having been prepared under the directio
3、n of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 March 2000 BSI 03-2000 ISBN 0 580 35457 1 BS EN 13091:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standar
4、d is the official English language version of EN 13091:1999. The UK participation in its preparation was entrusted to Technical Committee CII/58, Biotechnology, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the i
5、nterpretation, 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 committee can be obtained on request to its secretary. Cross-references The British Standards
6、 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 Catalogue. A British Standard do
7、es 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 ins
8、ide front cover, the EN title page, pages 2 to 19 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.(8523($167$1$5 1250(8523e(11( (8523b,6&+(1250 (1 HFHPEHU ,&6 (QJOLVKYHUVLRQ %LRWHFKQRORJ3HUIRUPDQFHFULWHULDIRUILOWHUHOHPHQWV DQGILOWUDWL
9、RQDVVHPEOLHV %LRWHFKQRORJLH&ULWqUHVGHSHUIRUPDQFHSRXUOHVpOpPHQWV ILOWUDQWVHWOHVILOWUHV %LRWHFKQLN/HLVWXQJVNULWHULHQIU)LOWHUHOHPHQWHXQG )LOWUDWLRQVHLQULFKWXQJHQ 7KLV(XURSHDQ6WDQGDUGZDVDSSURYHGE&(1RQ6HSWHPEHU &(1PHPEHUVDUHERXQGWRFRPSOZLWKWKH&(1&(1(/(&,QWHUQDO5HJXODWLRQVZKLFKVWLSXODWHWKHFRQGLWLRQVIRUJLY
10、LQJWKLV(XURSH DQ 6WDQGDUGWKHVWDWXVRIDQDWLRQDOVWDQGDUGZLWKRXWDQDOWHUDWLRQ8SWRGDWHOLVWVDQGELEOLRJUDSKLFDOUHIHUHQFHVFRQFHUQLQJV XFKQDWLRQDO VWDQGDUGVPDEHREWDLQHGRQDSSOLFDWLRQWRWKH&HQWUDO6HFUHWDULDWRUWRDQ&(1PHPEHU 7KLV(XURSHDQ6WDQGDUGHLVWVLQWKUHHRIILFLDOYHUVLRQV(QJOLVK)UHQFK*HUPDQ$YHUVLRQLQDQRWKHUODQJXD
11、JHPDGHEWUD QVODWLRQ XQGHUWKHUHVSRQVLELOLWRID&(1PHPEHULQWRLWVRZQODQJXDJHDQGQRWLILHGWRWKH&HQWUDO6HFUHWDULDWKDVWKHVDPHVWDWXVDVW KHRIILFLDO YHUVLRQV &(1PHPEHUVDUHWKHQDWLRQDOVWDQGDUGVERGLHVRI$XVWULD%HOJLXP&HFK5HSXEOLFHQPDUN)LQODQG)UDQFH*HUPDQ*UHHFH ,FHODQG,UHODQG,WDO/XHPERXUJ1HWKHUODQGV1RUZD3RUWXJDO6SDLQ
12、6ZHGHQ6ZLWHUODQGDQG8QLWHG.LQJGRP (8523($1 &200,77( )25 67$1$5,=$7,21 &20,7e(8523e(1(1250$/,6$7,21 (8523b,6&+(6.20,7()h5125081* &HQWUDO6HFUHWDULDWUXHGH6WDVVDUW%UXVVHOV &(1 $OOULJKWVRIHSORLWDWLRQLQDQIRUPDQGEDQPHDQVUHVHUYHG ZRUOGZLGHIRU&(1QDWLRQDO0HPEHUV 5HI1R(1(3DJH (1 %6, &RQWHQWV 3DJH )RUHZRUG ,QWUR
13、GXFWLRQ 6FRSH 1RUPDWLYHUHIHUHQFHV 7HUPVDQGGHILQLWLRQV +DDUGV 3HUIRUPDQFHFODVVHV &ODVVLILFDWLRQDQGYHULILFDWLRQRISHUIRUPDQFH 0DUNLQJDQGSDFNDJLQJ RFXPHQWDWLRQ $QQH$LQIRUPDWLYH*XLGDQFHRQWHVWPHWKRGV %LEOLRJUDSK 3DJH (1 %6, )RUHZRUG 7KLV(XURSHDQ6WDQGDUGKDVEHHQSUHSDUHGE7HFKQLFDO&RPPLWWHH&(17& %LRWHFKQRORJW
14、KH6HFUHWDULDWRIZKLFKLVKHOGE$)125 7KLV(XURSHDQ6WDQGDUGVKDOOEHJLYHQWKHVWDWXVRIDQDWLRQDOVWDQGDUGHLWKHUESXEOLFDWLRQ RIDQLGHQWLFDOWHWRUEHQGRUVHPHQWDWWKHODWHVWE0DDQGFRQIOLFWLQJQDWLRQDO VWDQGDUGVVKDOOEHZLWKGUDZQDWWKHODWHVWE0D $FFRUGLQJWRWKH&(1&(1(/(&,QWHUQDO5HJXODWLRQVWKHQDWLRQDOVWDQGDUGVRUJDQLDWLRQV RIWKH
15、IROORZLQJFRXQWULHVDUHERXQGWRLPSOHPHQWWKLV(XURSHDQ6WDQGDUG$XVWULD%HOJLXP &HFK5HSXEOLFHQPDUN)LQODQG)UDQFH*HUPDQ*UHHFH,FHODQG,UHODQG,WDO /XHPERXUJ1HWKHUODQGV1RUZD3RUWXJDO6SDLQ6ZHGHQ6ZLWHUODQGDQGWKH8QLWHG .LQJGRP3DJH (1 %6, ,QWURGXFWLRQ )LOWHUHOHPHQWVEQDWXUHDUHQRWLQWHQGHGWRSUHYHQWWKHSDVVDJHRIIOXLGVEXWWR
16、UHPRYHRU UHGXFHWKHPLFURRUJDQLVPORDGWRDFFHSWDEOHOHYHOVEUHWHQWLRQRIWKHWDUJHW PLFURRUJDQLVPVZLWKLQWKHILOWHUPHGLXP/HDNWLJKWQHVVLQWKLVFRQWHWUHIHUVWRWKHDELOLWRI WKHILOWUDWLRQDVVHPEOWRUHWDLQWKHWDUJHWPLFURRUJDQLVP 8VHRIWKLV(XURSHDQ6WDQGDUGZLOODLGWKHHTXLSPHQWPDQXIDFWXUHULQWKHFODVVLILFDWLRQRI ILOWHUHOHPHQWVDQ
17、GILOWUDWLRQDVVHPEOLHVZLWKUHJDUGWRELRVDIHWSHUIRUPDQFHLQ ELRWHFKQRORJLFDOSURFHVVHV7KHFODVVLILFDWLRQLVHDVLOXQGHUVWDQGDEOHDQGUHDGLOXWLOLDEOH IRUWKHXVHUDQGWKHFRPSHWHQWDXWKRULWLHV 6FRSH 7KLV(XURSHDQ6WDQGDUGVSHFLILHVSHUIRUPDQFHFULWHULDIRUILOWHUHOHPHQWVDQGILOWUDWLRQ DVVHPEOLHVXVHGLQELRWHFKQRORJLFDOSURFHVVHV
18、ZLWKUHVSHFWWRWKHSRWHQWLDOULVNVRI PLFURRUJDQLVPVLQXVHIRUWKHZRUNHUDQGWKHHQYLURQPHQW 7KLV(XURSHDQ6WDQGDUGDSSOLHVZKHUHWKHLQWHQGHGXVHRIWKHILOWHUHOHPHQWVRUILOWUDWLRQ DVVHPEOLHVLQFOXGHVKDDUGRXVRUSRWHQWLDOOKDDUGRXVPLFURRUJDQLVPVXVHGLQ ELRWHFKQRORJLFDOSURFHVVHVDQGRUZKHUHHSRVXUHRIWKHZRUNHURUWKHHQYLURQPHQWWRVX
19、FK PLFURRUJDQLVPVLVUHVWULFWHGIRUUHDVRQVRIVDIHW 7KLV(XURSHDQ6WDQGDUGDSSOLHVWRVWHULOLDELOLWDQGFOHDQDELOLWRIILOWHUDVVHPEOLHVDQGWR OHDNDJHRIPLFURRUJDQLVPVWKURXJKWKHKRXVLQJRIDILOWUDWLRQDVVHPEODQGWROHDNDJHRI PLFURRUJDQLVPVWKURXJKILOWHUHOHPHQWVIRUGHDGHQGILOWUDWLRQDQGFURVVIORZILOWUDWLRQ 7KLV(XURSHDQ6WDQGDUG
20、GRHVQRWDSSOWRILOWHUHOHPHQWVDQGILOWUDWLRQDVVHPEOLHVXVHGWR DYRLGFRQWDPLQDWLRQRIELRUHDFWRUVIRUHDPSOHEVWHULOLLQJLQOHWDLURUIHHGVWUHDP 1RUPDWLYHUHIHUHQFHV 7KLV(XURSHDQ6WDQGDUGLQFRUSRUDWHVEGDWHGRUXQGDWHGUHIHUHQFHSURYLVLRQVIURPRWKHU SXEOLFDWLRQV7KHVHQRUPDWLYHUHIHUHQFHVDUHFLWHGDWWKHDSSURSULDWHSODFHVLQWKHWHWD
21、QG WKHSXEOLFDWLRQVDUHOLVWHGKHUHDIWHU)RUGDWHGUHIHUHQFHVVXEVHTXHQWDPHQGPHQWVWRRU UHYLVLRQVRIDQRIWKHVHSXEOLFDWLRQVDSSOWRWKLV(XURSHDQ6WDQGDUGRQOZKHQ LQFRUSRUDWHGLQLWEDPHQGPHQWRUUHYLVLRQ)RUXQGDWHGUHIHUHQFHVWKHODWHVWHGLWLRQRIWKH SXEOLFDWLRQUHIHUUHGWRDSSOLHV (1 )RRGSURFHVVLQJPDFKLQHU%DVLFFRQFHSWV3DUW+JLHQH
22、 UHTXLUHPHQWV (1 %LRWHFKQRORJ(TXLSPHQW*XLGDQFHRQWHVWLQJSURFHGXUHVIRU FOHDQDELOLW (1 %LRWHFKQRORJ(TXLSPHQW*XLGDQFHRQWHVWLQJSURFHGXUHVIRU VWHULOLDELOLW (1 %LRWHFKQRORJ(TXLSPHQW*XLGDQFHRQWHVWLQJSURFHGXUHVIRU OHDNWLJKWQHVV3DJH (1 %6, (1 %LRWHFKQRORJ/DUJHVFDOHSURFHVVDQGSURGXFWLRQ*XLGDQFHRQ HTXLSPHQWVHOHF
23、WLRQDQGLQVWDOODWLRQLQDFFRUGDQFHZLWKWKHELRORJLFDOULVN (1,62 *HRPHWULFDO3URGXFW6SHFLILFDWLRQV*366XUIDFHWHWXUH3URILOHPHWKRG 7HUPVGHILQLWLRQVDQGVXUIDFHWHWXUHSDUDPHWHUV,62 (1,62 *HRPHWULFDO3URGXFW6SHFLILFDWLRQV*366XUIDFHWHWXUH3URILOHPHWKRG 5XOHVDQG3URFHGXUHVIRUWKHDVVHVVPHQWRIVXUIDFHWHWXUH,62 7HUPVDQGGHIL
24、QLWLRQV )RUWKHSXUSRVHVRIWKLVVWDQGDUGWKHIROORZLQJGHILQLWLRQVDSSO DULWKPHWLFDOPHDQGHYLDWLRQRIWKHSURILOH 5 D WKHDULWKPHWLFDOPHDQRIWKHDEVROXWHYDOXHVRIWKHSURILOHGHSDUWXUHVZLWKLQWKHVDPSOLQJ OHQJWK(1,62 FDUWULGJH GLVSRVDEOHILOWHUHOHPHQW FURVVIORZILOWUDWLRQ ILOWUDWLRQFKDUDFWHULHGEDIORZDORQJVLGHWKHILOWHUPHGL
25、XPVXUIDFHUHWHQWDWHDQGDIORZ FURVVLQJWKHILOWHUPHGLXPSHUPHDWH 127(DPSOHVRIFURVVIORZILOWUDWLRQDUHUHYHUVHGRVPRVLVGLDOVLVPLFURILOWUDWLRQ XOWUDILOWUDWLRQDQGQDQRILOWUDWLRQ FXWRII VPDOOHVWSDUWLFOHVLHRUPROHFXODUZHLJKWFRPSRQHQWVUHWDLQHGDWDJLYHQUHGXFWLRQ HIILFLHQF GHDGHQGILOWUDWLRQ ILOWUDWLRQFKDUDFWHULHGEDIHHGI
26、RUFHGWKURXJKWKHILOWHUPHGLXPGHSRVLWLQJUHWHQWDWHLQRU RQWKHILOWHUPHGLXP 127(DPSOHVRIGHDGHQGILOWUDWLRQDUHILOWUDWLRQEPHDQVRIVDQGILOWHUVZRXQGHG FDUWULGJHVKLJKHIILFLHQFSDUWLFXODWHDLU+(3$ILOWHUVVLQWHUHGJODVVILOWHUVDQGVWHULOLLQJ PHPEUDQHFDUWULGJHV3DJH (1 %6, GLUHFWWHVWPHWKRGLQELRWHFKQRORJ WHVWPHWKRGZKLFKHPSO
27、RVPLFURRUJDQLVPVIRUTXDQWLILFDWLRQ IHHG LQFRPLQJIOXLG ILOWUDWLRQDVVHPEO ILOWHUHOHPHQWPRXQWHGLQWRDILOWHUKRXVLQJ 127($ILOWUDWLRQDVVHPEOLVVRPHWLPHVFDOOHGDPRGXOH 127(7KHILOWHUKRXVLQJFDQLQFOXGHIRUHDPSOHYDOYHVSXPSVFRXSOLQJVDQGPRQLWRULQJ GHYLFHVWKDWHQDEOHDILOWUDWLRQRSHUDWLRQ 127($QHDPSOHRIKRZDILOWHUDVVHPEOL
28、VPDGHXSRIDILOWHUHOHPHQWDQGILOWHUKRXVLQJ LVJLYHQLQILJXUH )LOWHUPHGLXP 6XSSRUWLQJFRQVWUXFWLRQ )LOWHUKRXVLQJ )LOWHUHOHPHQW )LOWUDWLRQDVVHPEO )LJXUH(DPSOHRIDILOWUDWLRQDVVHPEO ILOWHUHOHPHQW FRPELQDWLRQRIDILOWHUPHGLXPDQGLWVVXSSRUWLQJFRQVWUXFWLRQ 127($ILOWUDWLRQDVVHPEOZLOOQRUPDOOFRQVLVWRIVHYHUDOILOWHUHOHPH
29、QWV7KHILUVWILOWHU HOHPHQWSUHILOWHUHOHPHQWZLOOUHWDLQWKHEXONRIWKHSDUWLFOHVLQWKHJDVRUOLTXLGLQRUGHUWR JLYHWKHILQDOILOWHUHOHPHQWVDORQJHUOLIHWLPH7KHSUHILOWHUHOHPHQWVZLOOXVXDOOKDYHD ORZHUUHGXFWLRQHIILFLHQFWKDQWKHILQDOILOWHUHOHPHQWV3DJH (1 %6, ILOWHUPHGLXP SKVLFDOEDUULHUFRQVLVWLQJRIDPHPEUDQHRUDQSRURXVPDWHUL
30、DO ILOWUDWHSHUPHDWH SDUWRIWKHIHHGSDVVLQJWKURXJKWKHILOWHUPHGLXP ILOWUDWLRQ VHSDUDWLRQWHFKQLTXHXVLQJDILOWHUPHGLXP 127()LOWUDWLRQFDQEHGRQHLQGHDGHQGRSHUDWLQJPRGHRULQFURVVIORZRSHUDWLQJPRGH KDDUG LQWULQVLFSURSHUWRUDELOLWRIVRPHWKLQJHJDJHQWHTXLSPHQWPDWHULDORUSURFHVVWRFDXVH KDUP(1 127(+DUPLVDQLQMXURUGDPDJHWR
31、KHDOWKRISHRSOHDQGRUWKHHQYLURQPHQW LQGLUHFWWHVWPHWKRGLQELRWHFKQRORJ WHVWPHWKRGZKLFKHPSORVSKVLFDODQGRUFKHPLFDOPHDQVIRUTXDQWLILFDWLRQ LQWHJULWWHVW WHVWWRYHULIFRQIRUPLWZLWKUHVSHFWWRVSHFLILFDWLRQVRIWKHILOWHUHOHPHQWFKDUDFWHULVWLFV 127($QLQWHJULWWHVWIRUDILOWHUHOHPHQWXVXDOOUHIHUVWRDQRQGHVWUXFWLYHLQGLUHFWWHV
32、WIRU DVVHVVPHQWRIIRUHDPSOHWKHUHWHQWLRQUDWH OHDNDJH HJUHVVIURPHTXLSPHQW ORJ UHGXFWLRQYDOXH / UY ORJDULWKPWRWKHEDVHRIWKHUDWLRRIWKHFRQFHQWUDWLRQRIWDUJHWPLFURRUJDQLVPVLQWKHIHHG DQGWKHFRQFHQWUDWLRQRIWDUJHWPLFURRUJDQLVPVLQWKHSHUPHDWHHSUHVVHGDV S I UY ORJ & & / =3DJH (1 %6, ZKHUH & I LVWKHFRQFHQWUDWLRQRIWD
33、UJHWPLFURRUJDQLVPVLQWKHIHHGHSUHVVHGLQQXPEHUVSHU PLOOLOLWUH & S LVWKHFRQFHQWUDWLRQRIWDUJHWPLFURRUJDQLVPVLQWKHSHUPHDWHHSUHVVHGLQQXPEHUV SHUPLOOLOLWUH 127(6RPHWLPHVWKHWHUPWLWHUUHGXFWLRQYDOXH 7 U LVXVHGLQVWHDGRI / UY 127(ORJ UHGXFWLRQYDOXHVRIWKHILOWHUHOHPHQWVLQILOWUDWLRQDVVHPEOLHVFDQEHDGGHG LQRUGHUWRJHW
34、WKHWRWDOORJ UHGXFWLRQYDOXH PHPEUDQH EDUULHUVHSDUDWLQJUHWHQWDWHDQGSHUPHDWH PLFURRUJDQLVP DQPLFURELRORJLFDOHQWLWFHOOXODURUQRQFHOOXODUFDSDEOHRIUHSOLFDWLRQRURIWUDQVIHUULQJ JHQHWLFPDWHULDO(1 127()RUWKHSXUSRVHVRIWKLVVWDQGDUGWKHWHUPPLFURRUJDQLVPFRYHUVWKHWHUPRI ELRORJLFDODJHQWDFFRUGLQJWRWKHLUHFWLYH(&PLFURRU
35、JDQLVPVLQFOXGLQJWKRVH ZKLFKKDYHEHHQJHQHWLFDOOPRGLILHGFHOOFXOWXUHVDQGKXPDQHQGRSDUDVLWHVZKLFKFDQEH DEOHWRSURYRNHDQLQIHFWLRQDOOHUJRUWRLFLW SURFHVVPLFURRUJDQLVP PLFURRUJDQLVPXVHGIRUSURGXFWLRQSXUSRVHVLQDELRWHFKQRORJLFDOSURFHVVRUFRQVWLWXWLQJ SDUWRIWKHSURGXFWLWVHOI UHGXFWLRQHIILFLHQF HIILFLHQFRIDGHYLFHIRUH
36、DPSOHDILOWHUHOHPHQWWRGHFUHDVHWKHQXPEHURIYLDEOH PLFURRUJDQLVPVSDVVLQJLWPHDVXUHGEWKHORJ UHGXFWLRQYDOXH / UY 127(,QSUDFWLFHWKHWHUPUHPRYDOHIILFLHQFLVDOVRXVHG UHWHQWDWH SDUWRIWKHIHHGQRWSDVVLQJWKURXJKWKHILOWHUPHGLXP3DJH (1 %6, ULVN DFRPELQDWLRQRIWKHSUREDELOLWDQGWKHGHJUHHRIWKHSRVVLEOHLQMXURUGDPDJHWRKHDOWKL
37、Q DKDDUGRXVVLWXDWLRQ(1 VRLO DQXQZDQWHGPDWWHULQFOXGLQJSURGXFWUHVLGXHVPLFURRUJDQLVPVGXVWDQGGHEULV ,62& VWHULOH VWDWHRIEHLQJIUHHIURPYLDEOHPLFURRUJDQLVPV 127(,QSUDFWLFHQRVXFKDEVROXWHVWDWHPHQWUHJDUGLQJWKHDEVHQFHRIYLDEOH PLFURRUJDQLVPVFDQEHSURYHQ+RZHYHUVWHULOHFRQGLWLRQVFDQEHUHJDUGHGDVHVWDEOLVKHG EXVLQJDQDFFHSWHGRUUHFRJQLHGPHWKRGRIVWHULOLDWLRQ 127(7KHSURFHVVRILQDFWLYDWLRQRIYLDEOHPLFURRUJDQLVPVGXULQJDVWHULOLDWLRQ SURFHGXUHLVXVXDOOGHVFULEHGEDQHPSLULFDOPDWKHPDWLFDOIXQFWLRQFRPPRQODQ HSRQHQWLDOIXQFWLRQ
