EN 60601-2-31-2008 en Medical electrical equipment - Part 2-31 Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal p.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationM e d i c a l e l e c t r i c a l e q u i p m e n t P a r t 2 - 3 1 : P a r t i c u l a r r e q u i r e m e n t s f o r t h e b a s i c s a f e t ya n d e s s e n t i a l p e r f

2、 o r m a n c e o f e x t e r n a l c a r d i a c p a c e m a k e r s w i t h i n t e r n a l p o w e r s o u r c eBS EN 60601-2-31:2008+A1:2011National forewordThis British Standard is the UK implementation of EN 60601-2-31:2008 A1:2011.It is identical to IEC 60601-2-31:2008, incorporating amendment

3、 1:2011.It supersedes BS EN 60601-2-31:2008, which will be withdrawn on 3 August 2014.The UK participation in its preparation was entrusted by Technical CommitteeCH/150, Implants for surgery, to Subcommittee CH/150/2, A list of organizations represented on this committee can be obtained onrequest to

4、 its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. BSI 2011 ISBN 978 0 580 71134 3 I C S 1 1 . 0 4 0 . 0 1 ; 1 1 . 0 4 0 . 4 0Compliance with a British Standard cannot confer immunity from legal ob

5、ligations.This British Standard was published under the authority of the Standards P o l i c y a n d S t r a t e g y C o m m i t t e e o n 3 1 J u l y 2 0 0 9Amendments ssued since publicationDate T e x t a f f e c t e dBRITISH STANDARDBS EN 60601-2-31:2008+A1:2011+Cardiovascular implants.corrigenda

6、 i/30 September 2011 Implementation of IEC amendment 1:2011CENELEC endorsement A1:2011The start and finish of text introduced or altered by amendment is indicated inthe text by tags. Tags indicating changes to IEC text carry the number of theamendment. For example, text altered by IEC amendment 1 is

7、 indicated in thetext by .!“with EUROPEAN STANDARD EN 60601-2-31:2008+A1NORME EUROPENNE EUROPISCHE NORM011C E N E L E C European Committee for Electrotechnical Standardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungC en t r a l S e c r et a r i

8、a t : r u e d e St a s s a rt 3 5 , B - 1 05 0 Br u s s e ls 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.Ref. No. EN 60601-2-31:2008 EICS 11.040.01 Supersedes EN60601-2-31:1995 + A1:1998English versionMedical electricalequipment - Par

9、t 2-31: Particular requirements for the basic safetyand essential performance of external cardiac pacemakerswith internalpowersource(IEC 60601-2-31:2008)A ppareils lectromdicaux -Partie 2-31: Exigences particulires pour la scurit de base et les performances essentielles des stimulateurs cardiaques e

10、xternes source dnergie interne (CEI 60601-2-31:2008)Medizinische elektrische Gerte -Teil2-31: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit interner Stromversorgung(IEC 60601-2-31:2008)This European Standard was approved by

11、CE NELEC on 200 8-06-01. CENELEC members are bound to complyw i t h t h e C E N / C E N E L E C I n t e r n a l R e g u l a t i o n s w h i c h s t i p u l a t e t h e c o n d i t i o n s f o r g i v i n g t h i s E u r o p e a n S t a n d a r d the status of a national standard without any alterati

12、on. Up-to-date lists and bibliographical references concerning such national standards may be obtained onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any otherlanguage made by transla

13、tion under the responsibility of a CENELEC member into its own language and notifiedto the Central Secretariat has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzech Republic, Denmark, Estonia, Finland

14、, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.Augst 2Foreword The text of document 62D/603/CDV, future edition 2 of IEC 60601-

15、2-31, prepared by SC62D,Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to theIEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-31 on 2008-06-01.ThisEuropean StandardsupersedesEN 60601-2-31:1995 + A1:1998.EN 60601-2-31:2008 is aligned

16、 with EN 60601-1:2006, and contains minimal technical revisions fromEN 60601-2-31:1995.The following dateswere fixed: latest date by which the EN has to be implemented at national level by publication of an identicalnational standard or by endorsement(dop) 2009-03-01 latest date by which the nationa

17、l standards conflictingwith the EN have to be withdrawn (dow) 2011-06-01This European Standard has been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ.In this standa

18、rd, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text oftables is also in a smaller type. TERMS DEFINED IN C LAUSE 3

19、 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of allsubdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, e

20、tc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses ofClause 7).References to clauses within this standard are preceded by the term “Clause” followed by the clausenumber. References to subclauses within this collateral standard are by number only.In

21、 this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combinationof the conditions is true.The verbal formsused in thisstandard conformto usage described in AnnexH of the ISO/IEC Directives,Part 2. For the purposes of this standard, the auxiliary verb: “shal

22、l” means that compliance with a requirement or a test is mandatory for compliance with thisstandard; “should” means that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this standard; “may” is used to describe a permissible way to achieve compliance wit

23、h a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates thatthere is guidance or rationale related to that item in Annex AA.Annexes ZA and ZZ have been added by CENELEC._BS EN 60601-2-31:2008+A1:2011EN 60601-2-31:2008+A1:

24、2011 (E) 2 Endorsement noticeThe textofthe InternationalStandard IEC 60601-2-31:2008 wasapproved byCENELEC asa European Standard without any modification.In the official version, for Bibliography, the following notes have to be added for the standards indicated:IEC 60086-1 NOTE Harmonized as EN 6008

25、6-1:2007 (not modified).IEC 60086-2 NOTE Harmonized as EN 60086-2:2007 (not modified)._Foreword to amendment 1 The text of document 62D/918/FDIS, future amendment 1 to IEC 60601-2-31:2008, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submi

26、tted to the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to EN 60601-2-31:2008 on 2011-08-03. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying a

27、ny or all such patent rights. The following dates were fixed: latest date by which the amendment has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-05-03 latest date by which the national standards conflicting with the amendment have

28、 to be withdrawn (dow) 2014-08-03 _ Endorsement notice The text of amendment 1:2011 to the International Standard IEC 60601-2-31:2008 was approved by CENELEC as an amendment to the European Standard without any modification. _ BS EN 60601-2-31:2008+A1:2011EN 60601-2-31:2008+A1:2011 (E) 3 AA nnex ZA(

29、normative)Normative references to international publicationswith their corresponding European publications Replacement in Annex ZA of EN 60601-1:2006:Publication Year Title EN/HD YearIEC 60601-1-2 (mod)2007 Medical electrical equipment -Part 1-2: General requirements for basicsafetyand essential per

30、formance -Collateral standard: Electromagnetic compatibility-Requirements and testsEN 60601-1-2 2007Addition to Annex ZA of EN 60601-1:2006:Publication Year Title EN/HD YearISO 14708-2 2005 Implants for surgery - Active implantable medicaldevices - Part 2: Cardiac pacemakers- - ANSI/AAMI PC69 2007 A

31、ctive implantable medical devices -Electromagnetic compatibility - EMC testprotocols for implantable cardiac pacemakersand implantable cardioverter defibrillators- - _BS EN 60601-2-31:2008+A1:2011EN 60601-2-31:2008+A1:2011 (E) 4 A n n e x Z Z(informative)Coverage of Essential Requirements of EC Dire

32、ctivesThis European Standard has been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and within its scope the standard covers allrelevant essential requirements as given in Annex I of the EC Directive 93/42/EEC. Compliance with this standa

33、rd provides one means of conformity with the specified essentialrequirements of the Directive concerned.WARNING: Otherrequirementsand otherEC Directivesmaybe applicable to the productsfalling withinthe scope of this standard._BS EN 60601-2-31:2008+A1:2011EN 60601-2-31:2008+A1:2011 (E) 5 CONTENTSINTR

34、ODUCTION.7201.1 Scope,objectandrelatedstandards.8201.2 Normative references9201.3 Terms and definitions201.4 General requirements10201.5 GeneralrequirementsfortestingMEEQUIPMENT.12201.6 ClassificationofMEEQUIPMENTandMESYSTEMS12201.7 MEQUIPMENTidentification, marking anddocuments12201.8 Protectionaga

35、inst electricalHAZARDSfromMEEQUIPMENT15201.9 Protectionagainst MECHANICAL HAZARDSofMEEQUIPMENTandMESYSTEMS17201.10 Protectionagainst unwantedand excessiveradiation HAZARDS17201.11 Protection againstexcessive temperaturesand otherHAZARDS17201.12 Accuracyofcontrolsand instrumentsand protection against

36、hazardousoutputs18201.13 HAZARDOUSSITUATIONSand fault conditions.22201.14 PROGRAMMABLE ELECTRICALMEDICALSYSTEMS ( PEMS)2201.15 ConstructionofMEEQUIPMENT.22201.16 MESYSTEMS22201.17 ElectromagneticcompatibilityofMEEQUIPMENTand MESYSTEMS.22202 Electromagnetic compatibility Requirements andtests.22Annex

37、es.24AnnexAA(informative)Particularguidanceandrationale25Bibliography35Indexofdefinedtermsusedinthisparticularstandard36Figure201.101Measuringcircuit forthe PATIENT AUXILIARY CURRENTfor MEEQUIPMENT with anINTERNAL ELECTRICALPOWER SOURCE.17Figure201.102Measuringcircuit forthe MAXIMUM TRACKINGRATE20Fi

38、gure201.103 Initialoscilloscopedisplaywhenmeasuring MAXIMUM TRACKINGRATE.20Table 201.101 DistributedESSENTIALPERFORMANCE requirements12Table 201.102 DUAL CHAMBERconnectorterminal marking.13Table 201.103 Measurement methodaccuracy19Table202.101Static dischargerequirements.23TableAA.1 EXTERNAL PACEMAK

39、ERHAZARDinventory.26BS EN 60601-2-31:2008+A1:2011EN 60601-2-31:2008+A1:2011 (E) 6 16INTRODUCTION The minimumsafetyrequirementsspecified inthisparticularstandardare consideredtoprovide fora practical degree ofsafetyin the operation ofexternalcardiacpacemakerswith aninternalpowersource. Basically,CARD

40、IACPACEMAKERS treatcardiac arrhythmias.Such arrhythmias reduce cardiac outputandcan leadto confusion,dizziness,lossofconsciousnessanddeath. The objectiveofpacing isto restore cardiacrhythmand outputappropriate to the PATIENTsphysiologicalneeds.There are two distinctfamilies ofCARDIAC PACEMAKERS, PAC

41、EMAKERS andEXTERNALPACEMAKERS. E XTERNALPACEMAKERSareused to pace PATIENTStemporarilypriorto implantingan PACEMAKERaswellasfor temporary pacing related to othermedical procedures, e.g.open heart surgery.C ARDIACPACEMAKERSdifferinthe various waysinwhichtheymaintainand monitorcardiacactivity in differ

42、ent circumstances. The simplest model stimulates the atrium or ventricle independentlyofthecardiac activity;othersdetectatrialorventricularactivityandstimulate the atriumorventricle asandwhenthisisnecessary;others,morecomplex,detectthe spontaneous heartactivityand stimulateappropriatelytheatriumand/

43、ortheventricle.Certain PACEMAKERSworkonpresetfrequencyvalues,amplitudes andimpulseduration.Otherscanhave severalvaluesfor parameters.Standards forEXTERNAL PACEMAKERSrequireattentiontoinformationwhichwillaidinselectingand applying these devices. Itisthrough these aspectsofstandardization thatthe cent

44、ral roleofclinical experienceshouldbe,orhas been, acknowledged.Theabilityto predict howa willperformin a specific based ontesting ofa device to a setoftechnicalcriteriaislimited. Thisparticularstandarddoesnottakeintoconsiderationthespecificsafetyaspects ofEXTERNALPACEMAKERSthat are connected to a SU

45、PPLY MAINSwhilesimultaneouslyconnected tothe PATIENT. Thisparticularstandard amendsand supplementsIEC 60601-1 (third edition, 2005): Medicalelectrical equipment Part 1: General requirements for basic safety and essential performance, hereinafterreferredtoasthe generalstandard(see1.4). The requiremen

46、tsarefollowed byspecificationsfortherelevanttests.Following the decision taken bysubcommittee 62Datthe meeting in Washington in 1979, a“Generalguidance andrationale“section givingsomeexplanatorynotes,where appropriate, about themore importantrequirementsisincluded in AnnexAA.Clausesorsubclausesforwh

47、ich there are explanatorynotesin AnnexAAare marked with anasterisk(*).Aninventoryofthe PATIENTssafetyposedbyEXTERNALPACEMAKERSand a rationale forthe safetyrequirementscontainedinthisparticularstandardare given inAnnex AA.Itisconsidered thatknowledge ofthe reasonsforthese requirementswillnotonlyfacil

48、itate the properapplicationofthe standardbutwill,indue course,expediteanyrevisionnecessitatedbychanges inclinicalpracticeorasaresultofdevelopmentsintechnology.However,thisannexdoesnotformpartofthe requirementsofthisstandard. implantableimplantable!“PACEMAKER!“PATIENTBS EN 60601-2-31:2008+A1:2011EN 6

49、0601-2-31:2008+A1:2011 (E) 7 MEDICAL ELECTRICAL EQUIPMENT Part 2-31: Particular requirements for the basic safety and essential performance ofexternal cardiac pacemakers withinternal power source 201.1 Scope,objectand related standards Clause1 ofthe generalstandard1)applies,exceptasfollows: 201.1.1 *ScopeReplacement:ThisInternational Standard appliestothe BASIC SAFETY and ESSENTIAL PERFORMANCE ofEXTERNALPACEMAKERSpowered byanINTERNAL ELECTRICALPOWER SOURCE,herafterefredtoas