BS EN 60601-2-49-2001 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety of multifunction patient monitoring equipment《医疗用电气.pdf

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1、BRITISH STANDARD BS EN 60601-2-49: 2001 IEC 60601-2-49: 2001 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 NO COPYING WITHOUT BSI

2、 PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 60601-2-49:2001 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 Standards Policy and Strategy Committee on 8 November 200

3、1 BSI 8 November 2001 ISBN 0 580 38653 8 National foreword 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 Technical Committee CH/96, Patient Monitoring Equipment,

4、 which has the responsibility to: 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 IEC 60027-1. For a period of tim

5、e 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 Standards Catalogue under the se

6、ction 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 responsible for their correct applicatio

7、n. Compliance with a British Standard does not of itself confer immunity from legal obligations. 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 inter

8、national and European developments and promulgate them in the UK. 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. Amendment

9、s issued since publication Amd. No. Date CommentsEUROPEAN STANDARD EN 60601-2-49 NORME EUROPENNE EUROPISCHE NORM October 2001 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secre

10、tariat: rue de Stassart 35, B - 1050 Brussels 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-49:2001 E ICS 11.040.55 English version Medical electrical equipment Part 2-49: Particular requirements for the safety of m

11、ultifunction patient monitoring equipment (IEC 60601-2-49:2001) Appareils lectromdicaux Partie 2-49: Rgles particulires de scurit des appareils de surveillance multifonction des patients (CEI 60601-2-49:2001) Medizinische elektrische Gerte Teil 2-49: Besondere Festlegungen fr die Sicherheit von mult

12、ifunktionalen Patientenberwachungsgerten (IEC 60601-2-49:2001) This European Standard was approved by CENELEC on 2001-10-01. 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 standar

13、d 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 exists in three official versions (English, French, German). A version in any other

14、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 electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, Fr

15、ance, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EN 60601-2-942:100 - 2 - Foreword The text of document 62D/409/FDIS, future edition 1 of IEC 60601-2-49, prepared by SC 62D, Electromedical equipment, of IE

16、C TC 62, Electrical 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 st

17、andard or by endorsement (dop) 2002-07-01 latest date by which the national standards conflicting with the EN have to be withdrawn (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,

18、annex ZA is normative 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; explanations, advice, notes, general statements

19、 and exceptions: smaller roman type; test specifications: italic 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

20、 any modification. _ Page2 EN60601249:2001 BSI8November200160601-2-49 IEC:2001(E) 3 CONTENTS INTRODUCTION. 4 SECTION ONE GENERAL 1 Scope and object 5 2 Terminology and definitions. 6 5 Classification 8 6 Identification, marking and documents. 8 SECTION TWO ENVIRONMENTAL CONDITIONS SECTION THREE PROT

21、ECTION AGAINST ELECTRIC SHOCK HAZARDS 14 Requirements related to classification . 9 17 Separation 9 19 Continuous leakage currents and patient auxiliary currents.11 20 Dielectric strength13 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EX

22、CESSIVE RADIATION *36 Electromagnetic compatibility.14 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 49 Interruption of the power supply .15 SECTION EIGHT ACCURACY OF OPERATING DAT

23、A AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data.15 51 Protection against hazardous output.15 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly22 Appendix L References Publicatio

24、ns mentioned in this standard24 Annex AA (informative) Guidance and rationale.25 Annex BB (informative) Alarm diagrams of clause 5132 Annex EE (informative) Survey of insulation paths and test circuit.35 Annex KK (informative) Examples of patient leakage current measurements .36 Annex ZA (normative)

25、 Normative references to international publications with their corresponding European publications45 Annex ZB (informative) Other international publications mentioned in this standard with the references of the relevant European publications.45 Index of defined terms 43 Page3 EN60601249:2001 BSI8Nov

26、ember2001-10606-294 (1002:CEI)E 5 INTRODUCTION This Particular 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 p

27、riority over those of the General Standard, entitled Medical electrical equipment Part 1: 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

28、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, this annex does not form part of the requirements of this Standard. An asterisk (*) by a

29、clause or subclause number indicates that some explanatory 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 app

30、lication of alarms in medial electrical equipment. It is intended to harmonize this standard with the above-mentioned collateral standard after its publication. Page4 EN60601249:2001 BSI8November2001 6 -10606-294 (1002:CEI)E MEDICAL ELECTRICAL EQUIPMENT Part 2-49: Particular requirements for the saf

31、ety of multifunction patient monitoring equipment SECTION ONE GENERAL 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 2.2.10

32、1. The scope of this standard is restricted to EQUIPMENT having either 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 S

33、tandard is to specify requirements for the safety of MULTIFUNCTION PATIENT MONITORING EQUIPMENT. 1.3 Particular Standards Addition: This Particular Standard refers to IEC 60601-1 (1988): Medical electrical equipment Part 1: General requirements for safety as amended by its amendment 1 (1991) and ame

34、ndment 2 (1995). For brevity, Part 1 is referred to in this Particular Standard either as the General Standard or as the General Requirement(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 Gener

35、al 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 this Particular Standard. Addition means that the text of this Particular Standard is additional to the requirements of the Genera

36、l Standard. Amendment means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard. Page5 EN60601249:2001 BSI8November2001-10606-294 (1002:CEI)E 7 Subclauses or figures which are additional to those of the General Standard are numbered st

37、arting 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. Where there is no corresponding section, clause or subclause in this Particular Sta

38、ndard, 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 not to be applied, a statement to that effect is given in this Particular Standard

39、. The requirements of this Particular Standard take 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 Part 1: General requirements for safety 2. Collateral Standard: Electromagnetic

40、 compatibility Requirements and tests IEC 60601-1-4:1996, Medical electrical equipment Part 1: 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:

41、 2.2. EQUIPMENT types (classification) 2.2.101 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

42、purposes and to generate ALARMS 2.2.102 PHYSIOLOGICAL MONITORING UNIT 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 2.5.101 MULTIPLE FUNCTION measurement of more

43、than one physiological parameter Page6 EN60601249:2001 BSI8November2001 8 -10606-294 (1002:CEI)E *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 2.5.103 SINGLE FUNCTION meas

44、urement of one physiological parameter NOTE Examples of physiological functions are body temperature, ECG, invasive and non-invasive blood pressure etc. 2.12 Miscellaneous 2.12.101 ALARM a signal which indicates abnormal events occurring to the PATIENT or EQUIPMENT 2.12.102 INHIBITION disabling or S

45、ILENCING and disabling an ALARM until revoked intentionally 2.12.103 LATCHED ALARM an ALARM, the visual and auditory manifestation of which does not stop when the ALARM condition no longer exists 2.12.104 NON-LATCHED ALARM an ALARM, the auditory or visual and auditory manifestation of which stops wh

46、en the ALARM condition no longer exists 2.12.105 PHYSIOLOGICAL ALARM a signal which either indicates that a monitored physiological function is out of specified limits or indicates an abnormal PATIENT condition 2.12.106 SILENCE the stopping of an auditory ALARM manifestation by OPERATOR action *2.12

47、.107 SILENCE/RESET the stopping of an auditory or 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

48、) of the EQUIPMENT is not capable of accurately monitoring the PATIENT S condition Page7 EN60601249:2001 BSI8November2001-10606-294 (1002:CEI)E 9 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 ope

49、ration: Amendment: Delete all but CONTINUOUS OPERATION. 6 Identification, 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