BS EN 60601-2-27-2006 Medical electrical nequipment — nPart 2-27 Particular requirements for nthe safety including essential nperformance of electrocardiographic nmonitoring equipm.pdf

1、BRITISH STANDARDBS EN 60601-2-27:2006Incorporating corrigendum no. 1Medical electrical equipment Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment The European Standard EN 60601-2-27:2006 has the status of a British Stand

2、ardICS 11.040.50g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 60601-2-27:2006This British Standard was published under the authority of the

3、Standards Policy and Strategy Committee on 31 May 2006 BSI 2007ISBN 978 0 580 60888 9National forewordThis British Standard is the UK implementation of EN 60601-2-27:2006, incorporating corrigendum December 2006. It is identical with IEC 60601-2-27:2005. It supersedes BS EN 60601-2-27:1995 which is

4、withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/4, Electromedical equipment.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publ

5、ication 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 legal obligations.Amendments issued since publicationAmd. No. Date Comments17508 Corrigendum No. 131 Decem

6、ber 2007 In the EN foreword the 6th paragraph has been replaced. Addition of Annex ZAEUROPEAN STANDARD EN 60601-2-27 NORME EUROPENNE EUROPISCHE NORM April 2006 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elekt

7、rotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-27:2006 E ICS 11.040.50 Supersedes EN 60601-2-27:1994English version Medical electrical e

8、quipment Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005) Appareils lectromdicaux Partie 2-27: Exigences particulires de scurit, incluant les performances essentielles, des appareils de surveillance

9、 dlectrocardiographie (CEI 60601-2-27:2005) Medizinische elektrische Gerte Teil 2-27: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale von Elektrokardiographie-berwachungsgerten (IEC 60601-2-27:2005) This European Standard was approved by CENELEC on 2005-11-0

10、1. 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 alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtain

11、ed 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 translation under the responsibility of a CENELEC member into its own language and notified to the Centra

12、l Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Ne

13、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Incorporating corrigendum December 2006EN 60601-2-27:2006 Foreword The text of document 62D/529/FDIS, future edition 2 of IEC 60601-2-27, prepared by SC 62D, Electromedical equipment,

14、 of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-27 on 2005-11-01. This European Standard supersedes EN 60601-2-27:1994. It introduces essential performance to electrocardiographic monitoring equipment s

15、uch as defibrillator protection, performance requirements and alarming. The following dates were 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) 2006-11-01 latest date by which the national standards

16、conflicting with the EN have to be withdrawn (dow) 2008-11-01 This European Standard has been prepared under 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. In this standard, the

17、following print types are used: requirements, compliance with which can be tested, and definitions: roman type; notes, explanations, advice, introductions, general statements, exceptions and references: small roman type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STAN

18、DARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS. _ Endorsement notice The text of the International Standard IEC 60601-2-27:2005 was approved by CENELEC as a European Standard without any modification. _ 2 Annexes ZA and ZZ have been added by CENELEC. 3 EN 60601-2-27:2006 CONTENTS INTRODUCTION.5 SE

19、CTION ONE GENERAL 1 Scope and object6 2 Terminology and definitions 7 4 General requirements for tests9 5 Classification9 6 Identification, marking and documents 10 SECTION TWO ENVIRONMENTAL CONDITIONS SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 14 Requirements related to classification

20、.13 17 Separation13 20 Dielectric strength 16 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 36 Electromagnetic compatibility17 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTIO

21、N SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection.19 49 Interruption of the power supply20 SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT

22、50 Accuracy of operating data .21 51 Protection against hazardous output .30 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly.37 EN 60601-2-27:2006 4 Appendix L (normative) References Publications men

23、tioned in this standard .54 Annex AA (informative) General guidance and rationale 55 Annex BB (informative) Alarm diagrams of Clause 51 64 Annex ZZ (informative) Coverage of essential requirements of EC Directives .70 INDEX OF DEFINED TERMS 67 Figure 101 Alternating QRS complexes and ventricular tac

24、hycardia waveforms for testing pattern recognition capability according to 6.8.2 bb) 4) and 6.8.2 bb) 6)39 Figure 102 Set-up for radiated and conducted emission test according to 36.201.1b) 1)40 Figure 103 Set-up for radiated immunity test according to 36.202.3.41 Figure 104 Test circuit for HF surg

25、ery protection according to 36.202.101.42 Figure 105 Test set-up for HF surgery protection according to 36.202.101 43 Figure 106 Application of the test voltage to test the energy delivered by the defibrillator (See 17h)101.1)44 Figure 107 Test of protection against the effects of defibrillation (di

26、fferential mode) (See 17h)101.2.45 Figure 108 Test of protection against the effects of defibrillation (common mode) (See 17h)101.3)46 Figure 109 Arrangements of electrodes on sponge (See 17h)101.4).47 Figure 110 Test of recovery time from the effects of defibrillation (See 17h)101.448 Figure 111 Ge

27、neral test circuit .49 Figure 112 High frequency response (clause 50.102.8 a)50 Figure 113 Test waveforms for T-wave rejection (6.8.2 bb) 2, 50.102.13, 50.102.17) .50 Figure 114 Test circuit for common mode rejection (See 50.102.10).51 Figure 115 Baseline reset (See 50.102.11)52 Figure 116 Pacemaker

28、 pulse (see 50.102.12)52 Figure 117 Normal paced rhythm (see 50.102.13 and Figure 119)53 Figure 118 Ineffective pacing (heart rate at 30 1/min, pacemaker pulse at 80 1/min) (see 50.102.13) 53 Figure 119 Simulated QRS complex (see 50.102.13, 50.102.14 and 50.102.15) .53 Figure AA.1 Applied part with

29、multiple patient connections63 Figure BB.101 Non-latching alarms w/o silence/reset64 Figure BB.102 Non-latching alarms with silence/reset.64 Figure BB.103 Latched alarms with silence/reset 65 Figure BB.104 Two ALARMS with SILENCE/RESET 65 Figure BB.105 INHIBITION of ALARMS66 Figure BB.106 SUSPENSION

30、 of ALARMS 66 Table 101 ELECTRODES and NEUTRAL ELECTRODE, their position, identification and colour.10 Table 102 Protection against the effect of defibrillation (test conditions)15 Annex ZA (normative) Normative references to international publications with theircorresponding European publications.6

31、9 5 EN 60601-2-27:2006 INTRODUCTION This Particular Standard concerns the safety of electrocardiographic monitoring equipment including essential performance. It amends and supplements IEC 60601-1 (second edition 1988): Medical electrical equipment Part 1: General requirements for safety) and its Am

32、endment 1 (1991) and Amendment 2 (1995), hereinafter referred to as the General Standard. The requirements of this Particular Standard take priority over those of the General Standard. A “General guidance and rationale” for the requirements of this Particular Standard is included in Annex AA. It is

33、considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, Annex AA does not form pa

34、rt of the requirements of this Standard. An asterisk (*) by a clause or subclause number indicates that some explanatory notes are given in Annex AA. At the time of publication of this Particular Standard work was in progress to create a joint ISO/IEC collateral standard addressing “General requirem

35、ents and guidelines for the application of alarms in medical electrical equipment”. It is intended to harmonize this standard with the above-mentioned collateral standard following its publication. EN 60601-2-27:2006 6 MEDICAL ELECTRICAL EQUIPMENT Part 2-27: Particular requirements for the safety, i

36、ncluding essential performance, of electrocardiographic monitoring equipment SECTION ONE GENERAL The clauses and subclauses of this section of the General Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: *1.1 Scope Addition: This Par

37、ticular Standard specifies the particular safety requirements, including essential performance, for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 2.101 and hereinafter also referred to as EQUIPMENT. This standard is applicable to EQUIPMENT used in a hospital environment. If the EQUIP

38、MENT is used outside the hospital environment, such as in ambulances and air transport, the EQUIPMENT shall comply with this standard. NOTE Additional standards apply to the EQUIPMENT covering specifically use outside the hospital environment. This standard is not applicable to electrocardiographic

39、monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. ECG telemetry systems, ambulatory (“Holter“) monitors and other ECG recording devices are outside the scope of this Particular Standard. 1.2 Object Replacement

40、: The object of this Particular Standard is to specify particular requirements for the safety, including essential performance, of EQUIPMENT as defined in 2.101. 1.3 Particular standards Addition: This Particular Standard refers to IEC 60601-1:1988, Medical electrical equipment Part 1: General requi

41、rements for safety as amended by its Amendment 1 (1991) and Amendment 2 (1995). The General Standard takes into account IEC 60601-1-1:2000, Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems, IEC 60601-1-2:20

42、01, Medical electrical 7 EN 60601-2-27:2006 equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests and IEC 60601-1-4:1996, Medical electrical equipment Part 1: General requirements for safety 4. Collateral standard: Programmable

43、electric medical systems and its Amendment 1 (1999). For brevity, Part 1 is referred to in this Particular Standard either as the “General Standard” or as the “General Requirement(s)”, and IEC 60601-1-1, IEC 60601-1-2 and IEC 60601-1-4 as the “Collateral Standards”. The numbering of sections, clause

44、s and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: “Replacement” means that the clause or subclause of the General Standard is replaced completely by the text of

45、this Particular Standard. “Addition” means that the text of this Particular Standard is additional to the requirements of the General Standard. “Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Subclauses, tables o

46、r figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. The term “this Standard” is used to make reference to the General Standard and this Particular Standard taken together. Wh

47、ere there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the General Standard, although possibly not relevant, applies without modification; where it is intended that any part of the General Standard, although possibly relevant, is n

48、ot to be applied, a statement to that effect is given in this Particular Standard. The requirements of this Particular Standard take priority over those of the General Standard and Collateral Standard mentioned above. 2 Terminology and definitions This clause of the General Standard applies, except

49、as follows: Addition: 2.101 ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT (EQUIPMENT) device and associated LEAD WIRES and ELECTRODES for the monitoring and/or recording of heart action potentials and displaying the resultant data of one PATIENT 2.102 LEAD WIRE(S) cable(s) connected between ELECTRODE(S) and the device EN 60601-2-27:2006 8 2.103 LEAD(S) combination(s) of ELECTRODES and LEAD WIRES used for a c