BS EN 60601-1-2-2007 Medical electrical equipment General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and.pdf

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1、BRITISH STANDARDBS EN 60601-1-2:2007Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and testsICS 11.040.01; 33.100.10; 33.100.20g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g

2、3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58IncorporatingcorrigendumMarch 2010National forewordThis British Standard is the UK implementation of EN 60601-1-2:2007, incorporating corrigendum March 2

3、010. It was derived by CENELEC from IEC 60601-1-2:2007. It supersedes BS EN 60601-1-2:2002, which will be declared obsolescent and will be withdrawn on publication of the revised BS EN 60601-2 series.The CENELEC common modifications have been implemented at the appropriate places in the text. The st

4、art and finish of each common modification is indicated in the text by tags .The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/1, Common aspects of electrical equipment used in medical practice.A li

5、st of organizations represented on this subcommittee 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.Compliance with a British Standard cannot confer immunity from l

6、egal obligations.BS EN 60601-1-2:2007This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 28 September 2007 BSI 2010Amendments/corrigenda issued since publicationDate Comments 31 July 2010 Implementation of CENELEC corrigendum March 2010. Date of with

7、drawal added to ForewordISBN 978 0 580 70926 5EUROPEAN STANDARD EN 60601-1-2 NORME EUROPENNE EUROPISCHE NORM July 2007 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat:

8、 rue de Stassart 35, B - 1050 Brussels 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-1-2:2007 E ICS 11.040.01; 33.100.10; 33.100.20 Supersedes EN 60601-1-2:2001 + A1:2006English version Medical electrical equipment -

9、Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007, modified) Appareils lectromdicaux - Partie 1-2: Exigences gnrales pour la scurit de base et les performances essentielles - Nor

10、me collatrale: Compatibilit lectromagntique - Exigences et essais (CEI 60601-1-2:2007, modifie) Medizinische elektrische Gerte - Teil 1-2: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Elektromagnetische Vertrglichkeit - Anforderungen und

11、 Prfungen (IEC 60601-1-2:2007, modifiziert) This European Standard was approved by CENELEC on 2007-04-11. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alter

12、ation. 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 exists in three official versions (English, French, German). A version in any other language made by tr

13、anslation 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 electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia,

14、 Finland, 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. Incorporating corrigendum March 2010 2 Foreword The text of document 6

15、2A/560/FDIS, future edition 3 of IEC 60601-1-2, prepared by SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-1-2 on 2007-04-11. The f

16、ollowing date was fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2008-02-01 This European Standard supersedes EN 60601-1-2:2001 and its amendment A1:2006.This European Standard has been prepared unde

17、r a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as the general standard. This

18、EN 60601-1-2 was revised to structurally align it with EN 60601-1:2006 and to implement the decision of IEC SC 62A that the clause numbering structure of collateral standards written to EN 60601-1:2006 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical cha

19、nges are in Clause 4, which now recognizes that there is a general requirement for a risk management process in EN 60601-1:2006. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiologic

20、al equipment); or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general standard (e.g. alarm systems). In this collateral standard the following print types are used: requirements and definitions: in roman type; test specifications: in italic type; informa

21、tive material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTES: IN SMALL CAPITALS. NOTE Defined terms are not printed in

22、 SMALL CAPITALS in Table 1 through Table 8, in the tables in Annex C and in statements required to appear in the technical description or instructions for use because they are intended for the OPERATOR or RESPONSIBLE ORGANIZATION, who may not be familiar with the defined terms of EN 60601 standards.

23、 In referring to the structure of this standard, the term “clause” means one of the six numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 6 includes Subclauses 6.1, 6.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 6.1, 6.2 and 6.2.1 are

24、 all subclauses of Clause 6). latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-06-01 BS EN 60601-1-2:2007EN 60601-1-2:2007 (E) 3 References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References t

25、o subclauses within this standard are by 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

26、2. For the purposes of this standard, the 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

27、” is used to describe a permissible way to achieve compliance with a requirement or test. Clauses, subclauses, items and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text o

28、f the International Standard IEC 60601-1-2:2007 was approved by CENELEC as a European Standard with agreed common modifications. _ BS EN 60601-1-2:2007EN 60601-1-2:2007 (E) 4 CONTENTS INTRODUCTION H7 1 Scope, object and related standards H9 1.1 * Scope H9 1.2 Object H9 1.3 Related standards H9 2 Nor

29、mative references H9 3 Terms and definitions H11 4 General requirements H14 4.1 General requirements for ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS H14 4.2 * SINGLE FAULT CONDITION for ME EQUIPMENT. H15 5 Identification, marking and documents . H15 5.1 Marking on the outside of ME

30、EQUIPMENT or ME EQUIPMENT parts. H15 5.2 ACCOMPANYING DOCUMENTS . H16 6 ELECTROMAGNETIC COMPATIBILITY H38 6.1 EMISSIONS. H38 6.2 IMMUNITY H41 Annex A (informative) General guidance and rationale. H57 Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS. H

31、87 Annex C (informative) Example completion of Table 1 through Table 8 H90 Annex D (informative) Guidance in classification according to CISPR 11 H102 Annex E (informative) Guidance in the application of IEC 60601-1-2 to particular standards H105 Annex F (informative) ELECTROMAGNETIC ENVIRONMENTS H1

32、08 Annex G (informative) Guidance for determining if electrical equipment that is not ME EQUIPMENT and that is used in an ME SYSTEM is exempt from the EMC testing requirements of this collateral standard H109 Annex H (informative) Mapping between the elements of the second edition of IEC 60601-1-2 a

33、s amended and IEC 60601-1-2:2007 . H111 Annex ZA (normative) Normative references to international publications with their corresponding European publications123 Annex ZZ (informative) Coverage of Essential Requirements of EC Directives 125 Bibliography H119 Index of defined terms used in this colla

34、teral standard H121 HFigure 1 Instructions for completing Table 1 for CISPR 11 ME EQUIPMENT and ME SYSTEMS . H20 HFigure 2 Instructions for completing Table 1 for CISPR 14 and CISPR 15 ME EQUIPMENT H21 HFigure 3 Instructions for completing Table 2 H24 BS EN 60601-1-2:2007EN 60601-1-2:2007 (E) 5 HFig

35、ure 4 Instructions for completing Table 3 and Table 5 for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS. H30 HFigure 5 Instructions for completing Table 4 and Table 6 for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING . H31 HFigure A.1 Example of cable arrangement for radiated IMMUNITY test

36、H85 HFigure A.2 Examples showing maximum dimension for ME EQUIPMENT with one and with two cables H86 HFigure G.1 Procedure for determining if electrical equipment that is not ME EQUIPMENT and that is used in an ME SYSTEM is exempt from the EMC testing requirements of this collateral standard . H110

37、HTable 1 Guidance and MANUFACTURERS declaration ELECTROMAGNETIC EMISSIONS for all ME EQUIPMENT and ME SYSTEMS . H19 HTable 2 Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for all ME EQUIPMENT and ME SYSTEMS . H23 HTable 3 Guidance and MANUFACTURERS declaration electromagnetic IMMUN

38、ITY for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS. H26 HTable 4 Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING H27 HTable 5 Recommended separation distances between portable and mobile RF communications equipment and the

39、 ME EQUIPMENT or ME SYSTEM for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS. H28 HTable 6 Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING H29 HTable 7 Guidance and M

40、ANUFACTURERS declaration electromagnetic IMMUNITY for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS that are specified for use only in a shielded location H35 HTable 8 Guidance and MANUFACTURERS declaration electromagnetic IMMUNITY for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING and are s

41、pecified for use only in a shielded location H36 HTable 9 Modulation frequency, PHYSIOLOGICAL SIMULATION FREQUENCY, and OPERATING FREQUENCY H45 HTable 10 IMMUNITY TEST LEVELS for voltage dips . H54 HTable 11 IMMUNITY TEST LEVEL for voltage interruption H54 HTable B.1 Marking on the outside of ME EQU

42、IPMENT, ME SYSTEMS or their parts H87 HTable B.2 ACCOMPANYING DOCUMENTS, instructions for use. H88 HTable B.3 ACCOMPANYING DOCUMENTS, technical description. H89 HTable C.1 Example (1) of completed Table 1 . H90 HTable C.2 Example (2) of completed Table 1 . H91 HTable C.3 Example (3) of completed Tab

43、le 1 . H92 HTable C.4 Example of completed Table 2 H93 HTable C.5 Example (1) test, IMMUNITY and COMPLIANCE LEVELS . H94 HTable C.6 Example of completed Table 3 H95 HTable C.7 Example of completed Table 5 H96 HTable C.8 Example of completed Table 4 H97 HTable C.9 Example of completed Table 6 H98 HTa

44、ble C.10 Example (2) test, IMMUNITY and COMPLIANCE LEVELS . H98 BS EN 60601-1-2:2007EN 60601-1-2:2007 (E) 6 HTable C.11 Example of completed Table 7 H99 HTable C.12 Example (3) test, IMMUNITY and COMPLIANCE LEVELS . H100 HTable C.13 Example of completed Table 8 H101 HTable F.1 ELECTROMAGNETIC ENVIRO

45、NMENTS. H108 HTable H.1 Mapping between the elements of the eecond edition of IEC 60601-1-2 as amended and IEC 60601-1-2:2007 . H111 BS EN 60601-1-2:2007EN 60601-1-2:2007 (E) 7 INTRODUCTION The need for establishing specific ELECTROMAGNETIC COMPATIBILITY standards for MEDICAL ELECTRICAL EQUIPMENT an

46、d MEDICAL ELECTRICAL SYSTEMS is well recognized. In particular, the existence of ELECTROMAGNETIC EMISSION standards is essential for the protection of: safety services; other MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS; electrical equipment that is not ME EQUIPMENT (e.g. computers);

47、telecommunications (e.g. radio/TV, telephone, radio-navigation). Of even more importance, the existence of ELECTROMAGNETIC IMMUNITY standards is essential to assure safety of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS. ELECTROMAGNETIC COMPATIBILITY (see Definition H3.4) differs from

48、 other aspects of safety covered by IEC 60601-1 because the electromagnetic phenomena exist, with varying degrees of severity, in the normal use environment of all MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS and by definition the equipment must “perform satisfactorily” within its intended environment in order to establish ELECTROMAGNETIC COMPATIBILITY. This means that the conventional single fault approach to safety is not appropriate for application to ELECTROMAGNETIC COMPATIBILITY standards. The ELECTROMAGNETIC DISTURBANCE environment can be compared to ambient tempera