EN 60601-2-49-2001 en Medical Electrical Equipment - Part 2-49 Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment (Remains Current)《医用电气设备 第2-49部分.pdf

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1、BRITISH STANDARD Medical Electrical Equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment The European Standard EN 60601-2-49:2001 has the status of a British Standard ICs 11.040.55 BS EN 60601-2-49: 2001 IEC 60601-2-49: 2001 NO COPYING WITHOUT B

2、SI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 60601-2-49:2001 Amd. No. Date National foreword Comments This British Standard is the official English language version of EN 60601-2-49:2001. It is identical with IEC 60601-2-49:2001. The UK participation in its preparation was entrusted to T

3、echnical Committee CH196, Patient Monitoring Equipment, which has the responsibility to: - - aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related internati

4、onal and European developments and promulgate them in the UK. - A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IE

5、C 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. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI St

6、andards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsibl

7、e for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the

8、Standards Policy and Strategy Committee on 8 November 2001 Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 45 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. O BSI 8 November

9、 2001 ISBN O 580 38653 8 EUROPEAN STANDARD EN 60601-2-49 NORME EUROPENNE EUROPISCHE NORM October 200 1 ICs 11.040.55 English version Medical electrical equipment Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001) Appareils lectromdic

10、aux Medizinische elektrische Gerte Partie 2-49: Rgles particulires de scurit des appareils de surveillance muitifonction des patients Teil 2-49: Besondere Festlegungen fr die Sicherheit von multifunktionalen Patienten berwachungsgerten (CE1 60601 -2-4912001 ) (IEC 60601 -2-49:2001) This European Sta

11、ndard was approved by CENELEC on 2001-10-01. CENELEC members are bound to comply with the CENKENELEC 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 concern

12、ing 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 translation under the responsibility of a CENELEC member into it

13、s 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, N

14、orway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels O 2001 CENELEC -

15、 All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-49:2001 E Page 2 EN 60601-2-492001 Foreword The text of document 62D/409/FDIS, future edition 1 of IEC 60601-2-49, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electric

16、al equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-49 on 2001-10-01. 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 en

17、dorsement - latest date by which the national standards conflicting with the EN have to be withdrawn (dop) 2002-07-01 (dow) 2004-10-01 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annex ZA is n

18、ormative and annexes AA, BB, EE, KK and ZB are informative. Annexes ZA and ZB have been added by CENELEC. In this standard, the following print types are used: - requirements, compliance with which can be tested, and definitions: roman type; - - test specifications: italic type; explanations, advice

19、, notes, general statements and exceptions: smaller roman type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS. - Endorsement notice The text of the International Standard IEC 60601-2-49:2001 was approved by CENELEC as a European Standard without any mo

20、dification. O BSI 8 November 2001 Page 3 EN 60601-2-49:2001 CONTENTS INTRODUCTION . 4 SECTION ONE - GENERAL 1 Scope and object 5 Classification . 6 Identification, marking and documents 2 Terminology and . 6 SECTION TWO - ENVIRONMENTAL CONDITIONS SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZ

21、ARDS 14 Requirements related to classification . 9 17 Separation . . 9 19 Continuous le iliar 11 20 Dielectric strength 13 SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION *36 Electromagnetic compatibility . 14 SECTIO

22、N SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES ANDOTHERSAFETYHAZARDS 49 Interruption of the power supply . 15 SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 51 Accuracy

23、of operating data . 15 Protection against hazardous output . 15 SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN - CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly 22 Appendix L - References - Publications mentioned in this standard Annex AA (info

24、rmative) Guidance and rationale . Annex BB (informative) Alarm diagrams of clause 51. Annex EE (informative) Survey of insulation paths and test circuit 32 . .35 Annex KK (informative) Examples of patient leakage current measurements . Annex ZA (normative) Normative references to international publi

25、cations with their Annex ZB (informative) Other international publications mentioned in this standard with the Index of defined terms . corresponding European publications. references of the relevant European publications . O BSI 8 November 2001 Page 4 EN 60601-2-49:2001 INTRODUCTION This Particular

26、 Standard concerns the safety of multifunction patient monitoring equipment. It amends and supplements IEC 60601-1 (second edition 1988), hereinafter referred to as the General Standard. The requirements of this Particular Standard take priority over those of the General Standard, entitled “Medical

27、electrical equipment - Part I: General requirements for safety”. A “General guidance and rationale” for the requirements of this Particular Standard is included in annex AA. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the s

28、tandard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, this annex does not form part of the requirements of this Standard. An asterisk (*) by a clause or subclause number indicates that some explanato

29、ry notes are given in Annex A of this Particular Standard. At the time of the publication of this Particular Standard, work was in progress to create a joint ISO/IEC collateral standard addressing “General requirements and guidelines for the application of alarms in medial electrical equipment”. It

30、is intended to harmonize this standard with the above-mentioned collateral standard after its publication. O BSI 8 November 2001 Page 5 EN 60601-2-49:2001 MEDICAL ELECTRICAL EQUIPMENT - Fart 2-49: Particular requirements for the safety of multifunction patient monitoring equipment SECTION ONE - GENE

31、RAL This section of the General Standard applies except as follows: 1 Scope and object *1.1 Scope This Particular Standard applies to the safety requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in subclause 2.2.101. The scope of this standard is restricted to EQUIPMENT having ei

32、ther more than one APPLIED PART or more than one SINGLE FUNCTION, intended for connection to a single PATIENT. This standard does not specify requirements for individual monitoring functions. 1.2 Object The object of this Particular Standard is to specify requirements for the safety of MULTIFUNCTION

33、 PATIENT MONITORING EQUIPMENT. 1.3 Particular Standards Addition: This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment - Part 7: General requirements for safety as amended by its amendment 1 (1991) and amendment 2 (1 995). For brevity, Part 1 is referred to in this Par

34、ticular Standard either as the “General Standard” or as the “Gen era I Re q u i re m e n t ( s )” . The numbering of sections, clauses and subclauses of this Particular Standard corresponds to that of the General Standard. Changes to the text of the General Standard are specified by the use of the f

35、ollowing words: “Replacement” means that the clause or subclause of the 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. “Amendment” means that the cl

36、ause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. O BSI 8 November 2001 Page 6 EN 60601-2-49:2001 Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, 6

37、6, 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. Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause or subclause of the Gener

38、al Standard, although possibly not relevant, applies without modification; where 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. The requirements of this Particular Standard take

39、priority over those of the General Standard and Collateral Standard mentioned above. 1.5 Collateral standards Addition: IEC 60601-1-2: 1993, Medical electrical equipment - Patt 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests IEC 606

40、01-1-4:1996, Medical electrical equipment - Patt I: General requirements for safety - 4. Collateral standard: Programmable electric medical systems Amendment 1 (1999) 2 Terminology and definitions *2.1 .5 APPLIED PART Delete second dash. Additional definitions: 2.2. EQUIPMENT types (classification)

41、2.2.1 o1 MULTIFUNCTION PATIENT MONITORING EQUIPMENT (hereinafter referred to aS EQUIPMENT) modular or pre-configured device including more than one PHYSIOLOGICAL MONITORING UNIT designed to collect information from a single PATIENT and process it for monitoring purposes and to generate ALARMS 2.2.10

42、2 a part of the EQUIPMENT whose purpose is to collect information relating to (a) physiological function(s) and to process it for monitoring and summary diagnostic purposes 2.5 Currents PHYSIOLOGICAL MONITORING UNIT 2.5.101 MULTIPLE FUNCTION measurement of more than one physiological parameter O BSI

43、 8 November 2001 Page 7 EN 60601-2-49:2001 *2.5.102 PART LEAKAGE CURRENT Current flowing from a SINGLE FUNCTION through the PATIENT to the remaining SINGLE FUNCTION (S) Of the Same APPLIED PART under NORMAL CONDITIONS 2.5.1 03 measurement of one physiological parameter NOTE Examples of physiological

44、 functions are body temperature, ECG, invasive and non-invasive blood pressure etc. SINGLE FUNCTION 2.12 Miscellaneous 2.12.101 a signal which indicates abnormal events occurring to the PATIENT or EQUIPMENT ALARM 2.12.102 disabling or SILENCING and disabling an ALARM until revoked intentionally INHI

45、BITION 2.1 2.1 03 an ALARM, the visual and auditory manifestation of which does not stop when the ALARM condition no longer exists LATCHED ALARM 2.12.104 an ALARM, the auditory or visual and auditory manifestation of which stops when the ALARM condition no longer exists NON-LATCHED ALARM 2.12.105 a

46、signal which either indicates that a monitored physiological function is out of specified limits or indicates an abnormal PATIENT condition PHYSIOLOGICAL ALARM 2.1 2.106 SILENCE the stopping of an auditory ALARM manifestation by OPERATOR action *2.12.107 SILENCEIRESET the stopping of an auditory or

47、auditory and visual ALARM manifestation and re-enabling system response to an ALARM condition 2.12.108 SUSPENSION disabling or SILENCING and disabling an ALARM temporarily 2.12.109 TECHNICAL ALARM a signal which indicates that the EQUIPMENT or part(S) Of the EQUIPMENT iS not capable Of accurately mo

48、nitoring the PATIENTS condition O BSI 8 November 2001 Page 8 EN 60601-2-49:2001 5 Classification *5.2 According to the degree of protection against electric shock: Amendment:Delete TYPE B APPLIED PART 5.6 According to the mode of operation: Amendment: Delete all but CONTINUOUS OPERATION. 6 Identific

49、ation, marking and documents 6.1 Marking on the outside of the EQUIPMENT Addition: aa) When detachable, each PHYSIOLOGICAL MONITORING UNIT shall be identified by the following markings and information: 1) manufacturers name or mark; 2) designation of the model either by a name specific to the model or by reference number or reference letters: 3) SERIAL NUMBER. Each PATIENT input connection on the APPLIED PART shall be marked for the function. Parts of an EQUIPMENT (for example, PATIENT CABLES or sensors) specified as not being protected against the effects of defibrillation