EN IEC 60601-2-2-2018(标准).pdf
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1、BSENIEC 60601-2-2:2018Medical electrical equipmentPart 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessoriesbsi.Eur o pean Co mmit t ee f o r El ec t r o t ec hnic al St andar dizat io nPr o vided by IH
2、S Mar kit under l ic ense w it h CENELECNo r epr o duc t io n o r net w o r king per mit t ed w it ho ut l ic ense f r o m IHSLic ensee=Cho ng q ing Inst it ut e o f q ual it y and St andar dizat io nb 5990390No t f o r Resal e,201 ad 0/9 06:49:32BS ENIEC 60601-2-2:2018BRITISH STANDARDNational forew
3、ordThis British Standard is the UK implementation ofEN IEC 60601-2-2:2018.It is identical to IEC 60601-2-2:2017.It supersedes BS EN 60601-2-2:2009+All:2011,which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/62/4,Electromedical equipment.A list of organ
4、izations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract.Users are responsible for its correct application.The British Standards Institution 2018Published by BSI Standards Limited 2018IS
5、BN 978 0 580 89316 2ICS 11.040.30Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2018.Amendments/corrigenda issued since publicationDate Text affectedEur
6、o pean Co mmit t ee f o r El ec t r o t ec hnic al St andar dizat io nPr o vided by IHS Mar kit under l ic ense w it h CENELECNo r epr o duc t io n o r net w o r king per mit t ed w it ho ut l ic ense f r o m IHSLic ensee=Cho ng q ing Inst it ut e o f q ual it y and St andar dizat io nb 5990390No t
7、f o r Resal e,201 ad 0/9 06:49:32BS EN IEC 60601-2-2:2018EN IEC 60601-2-2EUROPEAN STANDARDNORME EUROPEENNEEUROPAISCHE NORMMay 2018ICS 11.040.30Super sedes EN 60601-2-2:2009Eng l ish Ver sio nMedic al el ec t r ic al eq uipment-Par t 2-2:Par t ic ul ar r eq uir ement s f o r t he basic saf et y and e
8、ssent ial per f o r manc e o f hig h f r eq uenc y sur g ic al eq uipment and hig h f r eq uenc y sur g ic al ac c esso r ies(IEC 60601-2-2:2017)Appar eil s el ec t r o medic aux-Par t ie 2-2:Exig enc es Medizinisc he el ekt r isc he Ger at e-Teil 2-2:Beso nder epar t ic ul ier es po ur l a sec ur i
9、t e de base et l es per f o r manc es Fest l eg ung en f ur die Sic her heit einsc hl ie囚ic h deressent iel l es des appar eil s del ec t r o c hir ur g ie a c o ur ant haut e w esent l ic hen Leist ung smer kmal e vo n Ho c hf r eq uenz-f r eq uenc e et des ac c esso ir es del ec t r o c hir ur g i
10、e a c o ur ant Chir ur g ieg er at enhaut e f r eq uenc e(IEC 60601-2-2:2017)(IEC 60601-2-2:2017)This Eur o pean St andar d w as appr o ved by CENELEC o n 2017-05-05.CENELEC member s ar e bo und t o c o mpl y w it h t he CEN/CENELEC Int er nal Reg ul at io ns w hic h st ipul at e t he c o ndit io ns
11、 f o r g iving t his Eur o pean St andar d t he st at us o f a nat io nal st andar d w it ho ut any al t er at io n.Up-t o-dat e l ist s and bibl io g r aphic al r ef er enc es c o nc er ning suc h nat io nal st andar ds may be o bt ained o n appl ic at io n t o t he CEN-CENELEC Manag ement Cent r e
12、 o r t o any CENELEC member.This Eur o pean St andar d exist s in t hr ee o f f ic ial ver sio ns(Eng l ish,Fr enc h,Ger man).A ver sio n in any o t her l ang uag e made by t r ansl at io n under t he r espo nsibil it y o f a CENELEC member int o it s o w n l ang uag e and no t if ied t o t he CEN-C
13、ENELEC Manag ement Cent r e has t he same st at us as t he o f f ic ial ver sio ns.CENELEC member s ar e t he nat io nal el ec t r o t ec hnic al c o mmit t ees o f Aust r ia,Bel g ium,Bul g ar ia,Cr o at ia,Cypr us,t he Czec h Republ ic,Denmar k,Est o nia,Finl and,Fo r mer Yug o sl av Republ ic o f
14、 Mac edo nia,Fr anc e,Ger many,Gr eec e,Hung ar y,Ic el and,Ir el and,It al y,Lat via,Lit huania,Luxembo ur g,Mal t a,t he Net her l ands,No r w ay,Po l and,Po r t ug al,Ro mania,Ser bia,Sl o vakia,Sl o venia,Spain,Sw eden,Sw it zer l and,Tur key and t he Unit ed King do m.CENELECEuropean Committee
15、for Electrotechnical Standardization Comite Europeen de Normalisation Electrotechnique Europaisches Komitee fiir Elektrotechnische NormungCEN-CENELEC Management Cent r e:Rue de l a Science 23,B-1040 Br ussel s 2018 CENELEC Al l r ig ht s o f expl o it at io n in any f o r m and by any means r eser v
16、ed w o r l dw ide f o r CENELEC Member s.Ref.No.EN IEC 60601-2-2:2018 EEur o pean Co mmit t ee f o r El ec t r o t ec hnic al St andar dizat io nPr o vided by IHS Mar kit under l ic ense w it h CENELECNo r epr o duc t io n o r net w o r king per mit t ed w it ho ut l ic ense f r o m IHSLic ensee=Cho
17、 ng q ing Inst it ut e o f q ual it y and St andar dizat io nb 5990390No t f o r Resal e,2018/10/9 06:49:32BS ENIEC 60601-2-2:2018EN IEC 60601-2-2:2018(E)Eur opean f or ewor dThe t ext o f do c ument 62D/1427/FDIS,f ut ur e edit io n 6 o f IEC 60601-2-2,pr epar ed by SC 62D El ec t r o medic al eq u
18、ipment,o f IEC/TC 62 El ec t r ic al eq uipment in medic al pr ac t ic e w as submit t ed t o t he IEC-CENELEC par al l el vo t e and appr o ved by CENELEC as EN IEC 60601-2-2:2018.The f o l l o w ing dat es ar e f ixed:l at est dat e by w hic h t he do c ument has t o be(do p)2018-11-18 impl ement
19、ed at nat io nal l evel bypubl ic at io n o f an ident ic al nat io nal st andar d o r by endo r sement l at est dat e by w hic h t he nat io nal(do w)2021-05-18st andar ds c o nf l ic t ing w it h t hedo c ument have t o be w it hdr aw nThis do c ument super sedes EN 60601-2-2:2009.At t ent io n is
20、 dr aw n t o t he po ssibil it y t hat so me o f t he el ement s o f t his do c ument may be t he subjec t o f pat ent r ig ht s.CENELEC shal l no t be hel d r espo nsibl e f o r ident if ying any o r al l suc h pat ent r ig ht s.Endor sement not iceThe t ext o f t he Int er nat io nal St andar d IE
21、C 60602-2-2:2017 w as appr o ved by CENELEC as a Eur o pean St andar d w it ho ut any mo dif ic at io n.In t he o f f ic ial ver sio n,f o r Bibl io g r aphy,t he f o l l o w ing no t es have t o be added f o r t he st andar ds indic at ed:IEC 60529 NOTEIEC 60601-2-4:2010 NOTEIEC 60601-2-18:2009 NOT
22、EHar mo nized as EN 60529.Har mo nized as EN 60601-2-4:2011.Har mo nized as EN 60601-2-18:2015.2Eur o pean Co mmit t ee f o r El ec t r o t ec hnic al St andar dizat io nPr o vided by IHS Mar kit under l ic ense w it h CENELECNo r epr o duc t io n o r net w o r king per mit t ed w it ho ut l ic ense
23、 f r o m IHSLic ensee=Cho ng q ing Inst it ut e o f q ual it y and St andar dizat io nb 5990390No t f o r Resal e,2018/10/9 06:49:32BS ENIEC 60601-2-2:2018EN IEC 60601-2-2:2018(E)Annex ZA(no r mat ive)Nor mat ive r ef er ences t o int er nat ional publ icat ions wit h t heir cor r esponding Eur opea
24、n publ icat ionsThe f o l l o w ing do c ument s,in w ho l e o r in par t,ar e no r mat ivel y r ef er enc ed in t his do c ument and ar e indispensabl e f o r it s appl ic at io n.Fo r dat ed r ef er enc es,o nl y t he edit io n c it ed appl ies.Fo r undat ed r ef er enc es,t he l at est edit io n
25、o f t he r ef er enc ed do c ument(inc l uding any amendment s)appl ies.NOTE 1 When an Int er nat io nal Publ ic at io n has been mo dif ied by c o mmo n mo dif ic at io ns,indic at ed by(mo d),t he r el evant EN/HD appl ies.NOTE 2 Up-t o-dat e inf o r mat io n o n t he l at est ver sio ns o f t he
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