EN IEC 60601-2-2-2018（标准）.pdf

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 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 f o r Resal e,201 ad 0/9 06:49:32BS ENIEC 60601-2-2:2018BRITISH STANDARDNational forewordThis 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ofEN IEC 60601-2-2:2018.It is identical to IEC 60601-2-2:2017.It supersedes BS EN 60601-2-2:2009+All:2011,which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/62/4,Electromedical equipment.A list of organizations represented on this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 2018ISBN 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 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 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 essent 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 it 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 ie 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 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 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-CENELEC 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 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 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 ved 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 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 uipment,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 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 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 IEC 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 NOTEHar 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 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 opean 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 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 Eur o pean St andar ds l ist ed in t his annex is avail abl e her e:w w w.c enel ec.eu.Annex ZA of EN 60601-1:2006 applies,except as follows:Publ ic at io nYearTit l eEN/HDYearReplacement in Annex ZA of EN 60601-1:2006:IEC 60601-1-22014Medic al el ec t r ic al eq uipment-Par t 1-2:Gener al r eq uir ement s f o r basic saf et y and essent ial per f o r manc e-Co l l at er al St andar d:El ec t r o mag net ic dist ur banc es-Req uir ement s and t est sEN 60601-1-22015IEC 60601-1-82006Medic al el ec t r ic al eq uipment-Par t 1-8:Gener al r eq uir ement s f o r basic saf et y and essent ial per f o r manc e-Co l l at er al St andar d:Gener al r eq uir ement s,t est s and g uidanc e f o r al ar m syst ems in medic al el ec t r ic al eq uipment and medic al el ec t r ic al syst emsEN 60601-1-82007Publ ic at io nYearTit l eEN/HDYearAddition to Annex ZA of EN 60601-1:2006:CISPR 112015Indust r ial,sc ient if ic and medic al eq uipment-Radio-f r eq uenc y dist ur banc e c har ac t er ist ic s-Limit s and met ho ds o f measur ementEN 550112016EC 61000-4-32006El ec t r o mag net ic c o mpat ibil it y(EMC)-Par t 4-3:Test ing and measur ement t ec hniq ues-Radiat ed,r adio-f r eq uenc y,el ec t r o mag net ic f iel d immunit y t estEN 61000-4-32006IEC 61000-4-62013El ec t r o mag net ic c o mpat ibil it y(EMC)-Par t 4-6:Test ing and measur ement t ec hniq ues-Immunit y t o c o nduc t ed dist ur banc es,induc ed by r adio-f r eq uenc y f iel dsEN 61000-4-620143Eur 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 f o r Resal e,2018/10/9 06:49:32BS ENIEC 60601-2-2:2018-2-IEC 60601-2-2:2017 IEC 2017CONTENTSFOREWORD.4INTRODUCTION.7201.1 Sc o pe,o bjec t and r el at ed st andar ds.8201.2 No r mat ive r ef er enc es.9201.3 Ter ms and def init io ns.10201.4 Gener al r eq uir ement s.14201.5 Gener al r eq uir ement s f o r t est ing o f me equipment.15201.6 Cl assif ic at io n o f me equipment and me systems.15201.7 Me equipment ident if ic at io n,mar king and do c ument s.15201.8 Pr o t ec t io n ag ainst el ec t r ic al hazards f r o m me equipment.20201.9 Pr o t ec t io n ag ainst mechanical hazards o f me equipment and me systems.36201.10 Pr o t ec t io n ag ainst unw ant ed and exc essive r adiat io n hazards.36201.11 Pr o t ec t io n ag ainst exc essive t emper at ur es and o t her hazards.36201.12 Ac c ur ac y o f c o nt r o l s and inst r ument s and pr o t ec t io n ag ainst hazar do us o ut put s.38201.13 Hazardous situations and f aul t c o ndit io ns f o r me equipment.43201.14 Programmable electrical medical systems(pems).44201.15 Co nst r uc t io n o f me equipment.44201.16 Me systems.49201.17 El ec t r o mag net ic c o mpat ibil it y o f me equipment and me systems.49202*Electromagnetic disturbances-Req uir ement s and t est s.49208 Gener al r eq uir ement s,t est s and g uidanc e f o r al ar m syst ems in medic al el ec t r ic al eq uipment and medic al el ec t r ic al syst ems.50Annexes.51Annex AA(inf o r mat ive)Par t ic ul ar g uidanc e and r at io nal e.52Annex BB(inf o r mat ive)Electromagnetic disturbances c r eat ed by hf surgical EQUIPMENT.78Bibl io g r aphy.87Index o f def ined t er ms used in t his par t ic ul ar st andar d.89Fig ur e 201.101-Symbo l used w it h an earth referenced patient circuit.16Fig ur e 201.102-Symbo l used w it h a hf isolated patient circuit.16Fig ur e 201.103Cir c uit suit abl e f o r t est ing c o mpl ianc e t o 201.8.4.101.22Fig ur e 201.104-Measur ement o f hf leakage current f o r earth referenced patient circuits and l o ad bet w een el ec t r o des.25Fig ur e 201.105-Measur ement o f hf leakage current f o r earth referenced patient circuits and a l o ad r esist anc e f r o m active electrode t o ear t h.26Fig ur e 201.106-Measur ement o f hf leakage current f o r hf isolated patient circuits.27Fig ur e 201.107-Measur ement o f hf leakage current f r o m a bipolar accessory.28Fig ur e 201.108-Test appar at us f o r anc ho r ag es o f c o r ds o f active accessory.34Fig ur e 201.109-Measur ement o f o ut put po w er-monopolar o ut put.39Fig ur e 201.110-Measur ement o f o ut put po w er-bipolar o ut put.40Eur 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 f o r Resal e,2018/10/9 06:49:32BS ENIEC 60601-2-2:2018IEC 60601-2-2:2017 IEC 2017-3-Fig ur e 201.111-Met ho d o f t est ing f eedbac k f r o m o ne ac t ive o ut put t o ano t her in simul t aneo us ac t ivat io n.43Fig ur e AA.1-Exampl es o f var io us par t s o f an hf sur g ic al me system.54Fig ur e AA.2-Exampl e o f monopolar met ho d o f hf sur g er y using a neutral ELECTRODE.54Fig ur e AA.3-Exampl e o f bipolar met ho d o f hf sur g er y.55Fig ur e AA.4-Crest factor vs.peak vo l t ag e.60Fig ur e AA.5-Exampl e o f patient c ir c uit w it h neutral electrode r ef er enc ed t o ear t h at o per at ing f r eq uenc ies.64Fig ur e BB.1-E-field emissions t est set up.81Fig ur e BB.2-H-field emissions t est set up.82Fig ur e BB.3-Co nduc t ed emissions t est set up.83Fig ur e BB.4-Unit ad ho c t est.85Fig ur e BB.5-Po w er c o r d ad ho c t est.86Fig ur e BB.6-Accessory c o r d ad ho c t est.86Tabl e 201.101-Co l o ur s o f indic at o r l ig ht s and t heir meaning f o r hf surgical EQUIPMENT.16Tabl e 201.102-Maximum o ut put po w er s in single fault conditions.42Tabl e 201.103-Test c ur r ent s by w eig ht r ang e.46Tabl e AA.1-Summar y o f measur ed c ur r ent and dur at io ns f o r 25 TUR pr o c edur es.73Tabl e AA.2-Summar y o f measur ed c ur r ent s and dur at io ns f o r g ener al sur g ic al pr o c edur es.74Tabl e BB.1-Wo r st c ase emissions o f spar k g ap t ype hf surgical equipment.84Tabl e BB.2-Wo r st c ase emissions o f no n-spar k g ap(mo der n)hf surgical equipment.84No 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 IHSBS ENIEC 60601-2-2:2018-4-IEC 60601-2-2:2017 IEC 2017INTERNATIONAL ELECTROTECHNICAL COMMISSIONMEDICAL ELECTRICAL EQUIPMENT-Par t 2-2:Par t icul ar r equir ement s f or t he basic saf et y and essent ial per f or mance of high f r equency sur gical equipment and high f r equency sur gical accessor iesFOREWORD1)The Int er nat io nal El ec t r o t ec hnic al Co mmissio n(IEC)is a w o r l dw ide o r g anizat io n f o r st andar dizat io n c o mpr ising al l nat io nal el ec t r o t ec hnic al c o mmit t ees(IEC Nat io nal Co mmit t ees).The o bjec t o f IEC is t o pr o mo t e int er nat io nal c o-o per at io n o n al l q uest io ns c o nc er ning st andar dizat io n in t he el ec t r ic al and el ec t r o nic f iel ds.To t his end and in addit io n t o o t her ac t ivit ies,IEC publ ishes Int er nat io nal St andar ds,Tec hnic al Spec if ic at io ns,Tec hnic al Repo r t s,Publ ic l y Avail abl e Spec if ic at io ns(PAS)and Guides(her eaf t er r ef er r ed t o as IEC Publ ic at io n(s),).Their pr epar at io n is ent r ust ed t o t ec hnic al c o mmit t ees;any IEC Nat io nal Co mmit t ee int er est ed in t he subjec t deal t w it h may par t ic ipat e in t his pr epar at o r y w o r k.Int er nat io nal,g o ver nme