BS EN 60601-2-4-2011 Medical electrical equipment Particular requirements for the basic safety and essential performance of cardiac defibrillators《医用电气设备 心脏除颤器基础安全和基本性能的特定要求》.pdf

1、raising standards worldwide NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BSI Standards Publication Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators BS EN 60601-2-4:2011National foreword T

2、his British Standard is the UK implementation of EN 60601-2-4:2011. It is identical to IEC 60601-2-4:2010. It supersedes BS EN 60601-2-4:2003, which will be withdrawn on 12 January 2014. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medic

3、al Practice, to Subcommittee 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 applicatio

4、n. BSI 2011 ISBN 978 0 580 58180 9 ICS 11.040.10 Compliance 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 30 September 2011. Amendments issued since publication Amd. No.

5、 Date Text affected BRITISH STANDARD BS EN 60601-2-4:2011 EUROPEAN STANDARD EN 60601-2-4 NORME EUROPENNE EUROPISCHE NORM August 2011 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Manage

6、ment Centre: Avenue Marnix 17, B - 1000 Brussels 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-4:2011 E ICS 11.040.10 Supersedes EN 60601-2-4:2003English version Medical electrical equipment - Part 2-4: Particular r

7、equirements for the basic safety and essential performance of cardiac defibrillators (IEC 60601-2-4:2010) Appareils lectromdicaux - Partie 2-4: Exigences particulires pour la scurit de base et les performances essentielles des dfibrillateurs cardiaques (CEI 60601-2-4:2010) Medizinische elektrische G

8、erte - Teil 2-4: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Defibrillatoren (IEC 60601-2-4:2010) This European Standard was approved by CENELEC on 2011-01-12. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipul

9、ate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard

10、 exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national

11、electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, S

12、weden, Switzerland and the United Kingdom. BS EN 60601-2-4:2011EN 60601-2-4:2011 Foreword The text of document 62D/857/FDIS, future edition 3 of IEC 60601-2-4, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC paral

13、lel vote and was approved by CENELEC as EN 60601-2-4 on 2011-01-12. This European Standard supersedes EN 60601-2-4:2003. EN 60601-2-4:2011 constitutes a technical revision, revised to structurally align it with EN 60601-1:2006 and to implement the decision of IEC SC 62A that the clause numbering str

14、ucture of particular standards written to EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technica

15、l changes. The principle technical changes are as follows: 201.8.8.3, test 4: added additional test options; Figure 201.105: provided example of stainless steel plates. Added note for 10 Hz generator or shockable rhythm generator; Figure 201.101: Changed orientation of the lower diode at the oscillo

16、scope connection; 202.6.1, .2, .4: “Additions“ and “Replacements“ corrected to be as originally intended; 201.101.1: Clarified preconditioning of a non-rechargeable battery; 201.3.207: Clarified definition of DUMMY COMPONENT; 201.15.4.101: In paragraph b), added reduced flex requirements for sterili

17、zable internal paddles with specified limit on sterilization cycles; 201.15.4.3.103: Added an option for devices having non-changeable pre-programmed energy-setting sequences; 201.102.3.1, 2: Changed from specified defibrillation cycles to use of pre-programmed defibrillation sequence; 202.6.2.2.1:

18、Changed ESD discharge sequence to match EN 60601-1-2:2007. 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 any or all such patent rights. The following dates were fixed

19、: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2012-02-12 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2014-01-12 In this standard, the following print ty

20、pes 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 of tables is also in a smaller type. BS EN 60601-2-4:2011EN 60601-2-4:2011 TERMS DEFINED

21、 IN CLAUSE 3 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 all subdivisions (e.g. Clause 7 includes subclause

22、s 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are b

23、y number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, t

24、he auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way

25、 to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. This European Standard has been prepared under a mandate given to CEN

26、ELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive MDD (93/42/EEC). See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-4:2010 was approved by CENELE

27、C as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indicated: 2 IEC 60601-2-27 NOTE Harmonized as EN 60601-2-27. _ BS EN 60601-2-4:2011EN 60601-2-4:2011 Annex ZA (normative) Normative references to interna

28、tional publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any ame

29、ndments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies except as follows: Publication Year Title EN/HD Year Replace IEC 60601-1-2 by: IEC 60601-1-2 (mod) 2007 Medical elec

30、trical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2 + corr. March 2007 2010 Add: IEC 61000-4-2 - Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement

31、 techniques - Electrostatic discharge immunity test EN 61000-4-2 - ISO 15223-1 2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements - - BS EN 60601-2-4:2011EN 60601-2-4:2011 Annex ZZ (informative) Coverage of Es

32、sential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/4

33、2/EEC Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. BS EN 60601-2-4:20116 0 6 0 1 -

34、2 - 4 IEC:2010 C O N T E N T S 2 0 1 . 1 S c o p e , o b j e c t a n d r e l a t e d s t a n d a r d s . . 7 2 0 1 . 2 N o r m a t i ve r e fe r e n c e s . 9 2 0 1 . 3 T e r m s a n d d e f i n i t i o n s . 9 2 0 1 . 4 G e n e r a l r e q u i r e m e n t s . 1 1 2 0 1 . 5 G e n e r a l r e q u i r

35、 e m e n t s f o r t e s t i n g o f ME EQUIPMENT. 1 2 2 0 1 . 6 C la s s i f i c a t i o n o f ME EQUIPMENT a n d ME S Y S T E M S . . 1 2 2 0 1 . 7 M E E Q U I P M E N T i d e n t i f i c a t i o n , m a r k i n g a n d d o c u m e n t s . 1 3 2 0 1 . 8 P r o t e c t i o n a g a in s t e l e c t r

36、 i c a l H A Z A R D S from ME EQUIPMENT . . 1 7 2 0 1 . 9 P r o t e c t i o n a g a in s t MECA HNICAL H AZARDS of ME EQUIPMENT a n d ME S Y S T E M S . 2 3 2 0 1 . 1 0 P r o t e c t i o n a g a in s t u n w a n t e d a n d e x c e s s i ve r a d ia t i o n H A Z A R D S . 2 3 2 0 1 . 1 1 P r o t e

37、 c t i o n a g a in s t e x c e s s i ve t e m p e r a t u r e s a n d o t h e r H A Z A R D S . 2 3 2 0 1 . 1 2 * A c c u r a c y o f c o n t r o ls a n d i n s t r u me n t s a n d p r o t e c t i o n a g a in s t h a z a r d o u s o u t p u t s . 2 5 2 0 1 . 1 3 H A Z A R D O U S S I T U A T I O

38、N S and fau lt c ond itions . 2 7 2 0 1 . 1 4 P R O G R A M M A B L E E L E C T R I C A L M E D I C A L S Y S T E M S ( P E M S) . . 2 7 2 0 1 . 1 5 C o n s t r u c t i o n o f ME EQUIPMENT . . 2 7 2 0 1 . 1 6 M E S Y S T E M S 3 2 2 0 1 . 1 7 Electromagnetic compatibility of ME EQUIPMENT a n d ME S

39、 Y S T E M S . 3 2 2 0 1 . 1 0 1 * C h a r g i n g t i m e . . 3 2 2 0 1 . 1 0 2 I n t e r n a l e l e c t r i c a l p o w e r s o u r c e . . 3 5 2 0 1 . 1 0 3 * E n d u r a n c e . . 3 6 2 0 1 . 1 0 4 * S y n c h r o n i z e r . 3 7 2 0 1 . 1 0 5 * Recovery of the MONI TOR a n d / o r E C G i n p

40、u t a f t e r d e f i b r i l l a t i o n . . 3 7 2 0 1 . 1 0 6 * D is t u r b a n c e t o t h e MONITOR f r o m c h a r g i n g o r i n t e r n a l d i s c h a r g i n g . 4 1 2 0 1 . 1 0 7 * R e q u ir e m e n t s f o r R H Y T H M R E C O G N I T I O N D E T E C T O R . . 4 2 2 0 1 . 1 0 8 D E F

41、I B R I L L A T O R E L E C T R O D E S . 4 3 2 0 1 . 1 0 9 * E x t e r n a l p a c i n g ( U . S . ) . 4 5 2 0 2 * E l e c t r o m a g n e t i c c o m p a t i b i l i t y R e q u i r e m e n t s a n d t e s t s . . 4 9 A n n e x e s . 5 2 A n n e x C ( i n f o r m a t i ve ) G u id e t o ma r k i n

42、 g a n d la b e l l in g r e q u i r e m e n t s f o r ME EQUIPMENT a n d ME S Y S T E M S . 5 3 A n n e x A A ( i n f o r m a t i v e ) P a r t i c u l a r g u i d a n c e a n d r a t i o n a l e . 5 5 A n n e x B B ( in f o r m a t i ve ) M a p p in g b e t w e e n t h e e l e m e n t s o f t h e

43、s e c o n d e d i t i o n o f I E C 6 0 6 0 1 - 2 - 4 a n d I E C 6 0 6 0 1 - 2 - 4 : 2 0 1 0 . 6 8 Bibliography . 7 3 I n d e x o f d e f i n e d t e r m s u s e d i n t h i s p a r t i c u l a r s t a n d a r d . 7 4 F i g u r e 2 0 1 . 1 0 1 D y n a m i c t e s t f o r l i m i t a t i o n o f e n

44、 e r g y f r o m d i f f e r e n t p a r ts o f th e ME E Q U I P M E N T . 1 8 Figu re 201 .102 A llow ed curren t ve rs us app lied tes t vo ltage . 2 2 Figu re 201 .103 Exa mp les o f cord anch orages th at req u ire tes ting . 3 1 Figu re 201 .104 Tes t a ppara tus for fle xib le co rds and the

45、ir anc hora ges . 3 2 BS EN 60601-2-4:20116 0 6 0 1 - 2 - 4 IEC:2010 Figu re 201 .105 Ar range men t for tes t o f re co ve ry a fter de fib rilla tion . 3 9 Figu re 201 .106 Ar range men t of mon ito ring e le c trodes on s ponge . 4 0 Figu re 201 .107 Ar range men t for re co very tes t after de f

46、ibrillation 4 0 F i g u r e 2 0 1 . 1 0 8 A r r a n g e m e n t f o r t e s t o f d is t u r b a n c e f r o m c h a r g in g a n d in t e r n a l d i s c h a r g i n g .4 2 Figu re 201 .109 Tes t c ircu it for o ffs e t ins tab ility /in terna l no ise determina tion . 4 9 Figure 201.110 Test circu

47、it for D E F I B R I L L A T O R o ver load tes t o f pac ing ou tpu t circu itry . 4 9 T a b l e 2 0 1 . 1 0 1 D i s t r i b u t e d E S S E N T I A L P E R F O R M A N C E r e q u i r e m e n t s . 1 2 T a b l e 2 0 1 . 1 0 2 R h y t h m r e c o g n i t i o n d e t e c t o r c a t e g o r i e s .

48、4 2 T a b l e 2 0 1 . C . 1 0 1 M a r k i n g o n t h e o u t s i d e o f a C A R D I A C D E F I B R I L L A T O R or its p arts 5 3 T a b l e 2 0 1 . C . 1 0 2 M a r k i n g o f c o n t r o l s a n d i n s t r u m e n t s o f a C A R D I A C D E F I B R I L L A T O R . . 5 3 T a b l e 2 0 1 . C .

49、1 0 3 A CCOMPANYING DOCUMENTS, g e n e r a l . . 5 3 T a b l e 2 0 1 . C . 1 0 4 A CCOMPANYING DOCUMENTS, i n s t r u c t i o n s f o r u s e . 5 4 T a b l e 2 0 1 . C . 1 0 5 A CCOMPANYING DOCUMENTS, t e c h n i c a l d e s c r i p t i o n . 5 4 T a b l e B B . 1 M a p p i n g b e t w e e n t h e e l e m e n t s o f t h e s e c o n d e d i t i o n o f I E C 6 0 6 0 1 - 2 - 4 a n d I E C 6 0 6 0 1 - 2 - 4 : 2 0 1 0 . 6 8 BS EN 60601-2-4:201160601-2-4 IEC:2010