EN 60601-2-25-1995 en Medical Electrical Equipment - Part 2-25 Particular Requirements for the Safety of Electrocardiographs (Incorporates Amendment A1 1999 Remains Current)《医用电气设备.pdf

1、 tSTD-BSI BS EN bObOL-2-25-ENGL L77b m lb24bb7 0881420 738 BRITISH STANDARD Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs The European Standard EN 60601-2-251995 including its amendment A1:1999 has the status of a British Standard ICs 11.040.

2、50 BS EN 1996 IEC 1993 60 60 1-2-2 5: 6060 1-2-25: Incorporating Amendment No. 1 to (renumbers the BS as BS EN 60601 -2-25:1996) and incorporating Amendment No. 1 to BS EN BS 5724-2.125.d 993 60601 -2-259 996 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 60601-2-25:199

3、6 Amd.No. 9112 Committees responsible for this British Standard Date Comments July 1996 Renumbers BS 5724-2.1251993 as BS EN 60601-2-251996 The preparation of this British Standard was entrusted by the Healthcare Standards Policy Committee (HCC/-) to Technical Committee HCC/95, upon which the follow

4、ing bodies were represented: Biological Engineering Society British Cardiac Society Department of Health Electro Medical Trade Association Limited Institute of Hospital Engineering Institute of Physical Sciences in Medicine Ministry of Defence This British Standard, having been prepared under the di

5、rection of the Healthcare Standards Poiicy Committee, was published under the authority of the Standards Board and comes into effect on 15 June 1993 8 BSI 10-2000 The foilowing BSI references relate to the work on this standard Committee reference HCC/95 Draft for comment 81/26015 DC ISBN O 580 2218

6、7 3 Amendments issued since publication 10844 I October 2000 See national foreword I :STD*BSI BS EN bObUL-2-25-ENGL L99b m LbZYbb9 086lt422 700 m BS EN 60601-2-25:1996 Contents Page Committees responsible Inside front cover National foreword iii Foreword 2 Section 1. General 1 Scope and object 3 2 T

7、erminology and definitions 3 4 General requirements for tests 5 Classification 4 4 6 Identification, marking and documents 4 Section 2. Environmental conditions 10 Environmental conditions 7 Section 3. Protection against electric shock hazards 17 Separation 9 19 continuous LEAKAGE CURRENTS and PATIE

8、NT AUXILARY CURRENTS 9 20 Dielectric strength 9 Section 4. Protection against mechanical hazards Section 5. Protection against hazards from unwanted or excessive radiation 34 Ultraviolet radiation 13 Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures 36 Electromagnet

9、ic compatibility 15 Section 7. Protection against excessive temperatures and other safety hazards 42 Excessive temperatures 17 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization disinfection and compatibility 17 Section 8. Accuracy of operating data and protection

10、against hazardous output 51 Protection against hazardous output 19 Section 9. Abnormal operation and fault conditions; environmental tests Section 10. Constructional requirements 56 Components and general assembly 57 MAIN PARTS. comDonents and layout 23 23 Appendix L Annex AA (informative) General g

11、uidance and rationale 34 35 Annex ZAA (informative) A-deviations 39 Annex ZA (normative) Normative references to international publications with their corresponding European publications 39 Figure 104 - Test of protection against the effects of defibrillation 27 8 BSI 10-2000 i STDmBSI BS EN bObOL-2

12、-25-ENGt L77b H Lb2qbb7 OBBLir23 BS EN 60601-2-25:1996 Page Figure 105 - Test of protection against the effects of defibrillation 27 Figure 106 - Arrangements for ECG ELECTRODES on sponges 28 Figure 107 - Test of the recovery time from the effects on cardiac defibrillator discharge 28 Figure 108 - S

13、et-up for radiated and conducted emission test according to 36.201.1 29 Figure 109 - Set-up for radiated immunity test according to 36.202.2 30 Figure 110 - Test circuit for HF surgery interference measurement according to 36.202.101 31 Figure 11 1 - Test circuit for HF surgery interference measurem

14、ent according to 36.202.101 32 Table 102 - Test conditions: Protection against the effect of defibrillation 19 8 BSI 10-2000 *. 11 STD=BSI BS EN bOb01-2-25-ENGL 177b D Lb2Vbb7 0881VZV 583 m BS EN 60601-2-25:1996 National foreword This British Standard is the English language version of EN 60601-2-25

15、1995, including its amendment A1:1999. It is identical with IEC 60601-2-25:1993 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs, including amendment 1:1999, published by the International Electrotechnical Commission (IEC). This Particular Standard

16、 amends and supplements BS EN 60601-1:1990 hereinafter called the General Standard. As stated in 1.3 of the General Standard, the requirements of this Particular Standard take precedence over those of the General Standard. As in the General Standard, the requirements are followed by compliance tests

17、. The numbers of the sections and clauses in this standard refer to the related sections and clauses in the General Standard. Clauses, subclauses or figures that are additional to those of the General Standard are numbered starting from 101; additional appendices are lettered AA, BB, etc., and addit

18、ional items are lettered aa), bb), etc. The changes from the text of the General Standard are specified by the use of the following words. “Replacement” means that the clause, subclause or specified paragraph of the General Standard is replaced by the text of this standard. “Amendment” means that th

19、e clause, subclause or specified paragraph of the General Standard is amended as indicated by the text of this standard. “Addition” means that the text of this standard is additional to the requirements of the General Standard. Guidance and a rationale for the more important requirements are given i

20、n Annex AA. It is considered that a knowledge of the reasons for the requirements will not only facilitate the proper application of the standard but will expedite any subsequent revision. This annex does not form part of the standard. The start and finish of text introduced or altered by amendment

21、is indicated in the text by tags B M. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated byB M. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been r

22、enumbered as IEC 60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Additional information. The following print types are used in this standard. Requirements, compliance with which can be tested, and de

23、finitions: in roman type. Explanations, advice and general statements: in small roman type. Test procedures: in italic type. TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD AND IN THIS STANDARD: IN SMALL CAPITALS. NOTE Typographical error. In 1.3, paragraph 2, line 1 rievity” should be read as bre

24、vitf. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comp

25、rises a front cover, an inside front cover, pages i to iv, the EN title page, pages 2 to 18, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. . 111 O BSI 10-2000 EUROPEAN STANDARD NORME EUROPENNE EN 60601-2-25 Nov

26、ember 1995 + Al EUROPISCHE NORM June 1999 ICs 11.040.60 Descriptors: Medical electrical equipment, electrocardiographs, safety requirements, protection against electric shock, protection against mechanical hazard, radiation protection, fire protection, environmental conditions English version Medica

27、l electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (includes amendment A1:1999) (IEC 60601-2-25:1993 + A11999) Appareils lectromdicaux - Medizinische Elektroausrstungen - Partie 2-25: Rgles particulieres de scurit des Teil 2-25: Besondere lectrocardiogr

28、aphes Sicherheitsanforderungen fur (inclut l?amendement Al: 1999) Elektrokardiografieausrstungen (CE1 60601-2-251993 + A1:1999) (enthlt nderung Al: 1999) (IEC 60601-2-251993 + A1:1999) This European Standard was approved by CENELEC on 1995-06-16; amendment Al was approved by CENELEC on 1999-05-01. C

29、ENELEC members are bound to comply with the CENEENELEC 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 obtained on

30、 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 Central Sec

31、retariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENEL

32、EC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels Previous page is blank O 1995 Copyright reserved to CENELEC members Ref. No. EN 60601-2

33、-25:1995 + A1:1999 E STD-BSI BS EN bOb01-2-25-ENGL L99b 1b29bh7 088192b 35b EN 60601-2-25:1995 Foreword The text of the International Standard IEC 601-2-251993, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the formal vote and

34、was approved by CENELEC as EN 60601-2-25 on 1995-05-15 without any modifica tion. The following dates were fixed: - latest date by which the (dop) 1996-07-01 EN has to be implemented at national level by publication of an identical national standard or by endorsement national standards conflicting w

35、ith the EN have to be withdrawn - latest date by which the (dow) 1996-07-01 Annexes designated “informative” are given for information only. In this standard, Annex AA and Annex ZAA are informative. Annex ZAA has been added by CENELEC. Foreword to amendment Al The text of document 62D/309/FDIS, futu

36、re amendment 1 to IEC 60601-2-25, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as amendment Al to EN 60601-2-251995 on 1999-05-01. The following dates were fixed: - lat

37、est date by which the (dop) 2000-03-01 amendment has to be implemented at national level by publication of an identical national standard or by endorsement national standards conflicting with the amendment have to be withdrawn - latest date by which the (dow) 2002-05-01 Annexes designated “normative

38、” are part of the body of the standard. Annexes designated “informative” are given for information only. In this standard, Annex ZA is normative and Annex AA is informative. Annex ZA has been added by CENELEC. 2 Q BSI 10-2000 Section i. General The clauses and subclauses of this section of the Gener

39、al Standard apply except as follows: 1 Scope and object This clause of the General Standard applies except as follows: 1.1 *Scope Addition: This Particular International Standard specifies the particular safety requirements for ELECTROCARDIOGRAPHS as defined in 2.102, intended for the production of

40、detachable ELECTROCARDIOGRAMS for diagnostic purposes. It also applies to vector-cardiographs and EQUIPMENT for stress testing. This Particular Standard covers minimum safety requirements. Special requirements concerning use in ambulances, phono-cardiographs, cardiographic monitors, polygraphs, tele

41、metering, special tests (for example, His bundle electrocardiographs), etc. are not covered by this Particular Standard. EQUIPMENT with microelectrodes used directly in the fibres of the heart muscle is also excluded. 1.2 Object Replacement: The object of this Particular International Standard is to

42、 establish particular requirements for the safety of ELECTROCARDIOGRAPHS as defined in 2.102. 1.3 Particular Standards Addition: IEC 60601-1 (1988):Medical electrical equipment - Part 1: General requirements for safety as amended by its amendment 1 (1991) and amendment 2 (1995). The General Standard

43、 takes into account IEC 60601-2 (1993), Medical electrical equipment - Part 1 General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests. For brievity, Part 1 is referred to in this Particular Standard either as the “General Standard” or as the “

44、General Requirement(s)”. The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words: “Fteplacement” means that the clause or subclause of th

45、e General Standard is replaced completely by the text of this Particular Standard. “Addition” means that the text of this Particular Standard is additional to the requirements of the General Standard. This Particlular Standard refers to “Amendment” means that the clause or subclause of the General S

46、tandard is amended as indicated by the text of this Particular Standard. Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional appendices are lettered AA, BB, etc., and additional items aa), bb), etc. The term “this Standard” is used t

47、o make reference to the General Standard and this Particular Standard taken together. Where 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; wher

48、e it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. 2 Terminology and definitions This clause of the General Standard applies except as follows: Additional definitions: 2.101 ELECTR

49、OCARDIOGRAM (ECG) visible record of heart action potentials 2.102 ELECTROCARDIOGRAPH (ecg) MEDICAL ELECTRICAL EQUIPMENT and associated ELECTRODES intended for the production of detachable ELECTROCARDIOGRAMS for diagnostic purposes 2.103 ELECTRODE combination used for a certain ECG recording 2.104 ELECTRODE ELECTRODE attached to a specified part of the body to detect heart action voltages in combination with another ELECTRODE or ELECTRODES 2.105 LEAD SELECTOR system to select certain LEADS and TEST 2.106 MULTICHANNEL ELECTROCARDIOGRAPH EQUIPMENT f