EN 60601-2-34-2000 en Medical Electrical Equipment Part 2-34 Particular Requirements for the Safety Including Essential Performance of Invasive Blood Pressure Monitoring Equipment .pdf

1、Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment The European Standard EN 60601-234:2000 has the status of a British Standad ICs 11.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PER

2、MlTED BY COPYRIGFPT LAW BS EN 60601-2-342001 IEC 60601-2-34:2000 STD-BSI BS EN bObO1-2-34-ENGL 2001 1624bb9 0900925 790 BS EN 60601-2342001 AmdNo. National foreword Date Comments This British Standard is the official English ianguage version of EN 60601-234:2000. It is identical with IEC 60601-234:2

3、000. It supersedes BS EN 60601-234.1994 which iswithdram The UK participation in its preparation was entrusted to Technical Committee cw96, Monitring equipment, which has the responsibility to: - aid enquirers to understand the te* - present to the responsible inkrnalionaUEuropean committee any enqu

4、iries on the interpretation, or proposals for change, and keep the UK interests informed; - monitor related intedonai and European developments and promulgate themintheuK. A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all IEC

5、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 time during the change over fiom one numbering system to the other, publications may contain identifiers from both systems. Cross-references Attention is dram to the

6、 fact that CEN and CENELEC Standards normally include an annex which lists normative references to hternational publications with their corresponding European publications. The British Standards which implement these internationai or European publicaions may be found in the BSI Standards Catalogue u

7、nder the section entitled “International Standards Correspondence Index“, or by using the “Find“ facility of the BSI Standards Electronic Caalogue. A British Standard does not purport to include all the necessary provisions of a conhct Users of British Standards are responsible for their correct app

8、lication. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 58, an inside back cover and a back cover. The BSI copyright notice displayed in this d

9、ocument indicates when the document waslastissued. This British Standard, having been prepared under the direction of the Heaith and Environment Sector Committee, was published under the authority of the Standards CommiUee and comes into effect on 16 April 2001 0 BSI 04-2001 ISBN O 580 36773 8 STDmB

10、SI BS EN 60601-2-3Y-ENGL ZOOL Lb24669 090092b 627 9 EUROPEAN STANDARD EN 60601 12-34 NORME EUROPEENNE EUROPAISCHE NORM December 2000 ICs 11 .O4055 Supersedes EN 60601-2-34:1995 English version Medical electrical equipment Part 2-34: Particular requirements for the safety, including essential perform

11、ance, of invasive blood pressure monitoring equipment (IEC 60601 -2-34:2000) Appareils lectromdicaux Medizinische elektrische Gerte Partie 2-34: Rgles particulires de scurit pour les appareils de surveillance de la pression sanguine prleve directement Blutdruck- berwachungsgerten Teil 2-34: Besonder

12、e Festlegungen fr die Sicherheit einschlielich wesentlicher Leistungsmerkmale, von invasiven (CE1 60601 -2-3412000) (IEC 60601-2-34:2000) This European Standard was approved by CENELEC on 2000-1 1-01. CENELEC members are bound to comply with the CENKENELEC Internal Regulations which stipulate the co

13、nditions 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 application to the Central Secretariat or to any CENELEC member. This European Standard exists in

14、 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 Secretariat has the same status as the official versions. CENELEC members are the national electrotec

15、hnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normal

16、isation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretanat: rue de Stassart 35, B - 1050 Brussels O 2000 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-34:2000 E STD-BSI ES EN bObOL-2-3Y-

17、ENGL 2001 W 1624bb9 0900927 5b3 W Page 2 EN 60601-2-342000 Foreword The text of document 62D/367/FDIS, future edition 2 of IEC 60601-2-34, 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 appr

18、oved by CENELEC as EN 60601-2-34 on 2000-1 1-01. This European Standard supersedes EN 60601 -2-34:1995. 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 latest date by which the nati

19、onal standards conflicting with the EN have to be withdrawn Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annexes AA and BB are informative. Endorsement notice (dop) 2001-08-01 (dow) 2003-1 1-01

20、 The text of the International Standard IEC 60601-2-34:2000 was approved by CENELEC as a European Standard without any modification. STD-BSI BS EN 60bOL-2-34-ENGL 2OOL = Lb246h9 09033928 QTT Page 3 EN 60601-2-342000 CONTENTS Page INTRODUCTION 5 Clause SECTION ONE - GENERAL Scope and object . 6 Termi

21、nology and definitions . 7 General requirements for tests . 9 Classification . 9 Identification, marking and documents . 9 SECTION TWO - ENVIRONMENTAL CONDITIONS SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS 14 Requirements related to classification . 1 O 17 Separation . .I 1 19 COntinUO

22、US LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 11 20 Dielectric strength . 12 SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength 12 SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 36 ELECTROMAGNETIC COMPATIBILITY . 13 SECTION SIX - PROTECTI

23、ON AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES ANDOTHERSAFETYHAZARDS 42 Excessive temperatures 16 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, 45 Pressure vessel and parts subject to

24、 pressure 17 46 Humman errors . 18 AGAINST HAZARDOUS OUTPUT disinfection and compatibility 16 SECTION EIGHT -ACCURACY OF OPERATION DATA AND PROTECTION 50 Accuracy of operating data . 18 51 Protection against hazardous output . 18 SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL

25、TESTS SECTION TEN - CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly 28 57 Mains parts, components and layout . 28 Q BSI 04-2001 STDmBSI BS EN bObOL-2-34-ENGL ZOOL Lb24669 0900727 33b Page 4 EN 60601-2-34:2000 Annex AA (informative) Guidance and rationale for particular clauses and sub

26、clauses 45 Annex BE (informative) ALARM diagrams . 54 INDEX of defined terms 57 Bibliography . 58 Figure 101 . Measuring Circuit for PATIENT LEAKAGE CURRENT Via an F-TYPE (FLOATING) earth caused by an external voltage on the APPLIED PART 29 Figure 102 - Dynamic test for limitation of energy from dif

27、ferent parts - Recovery test . 30 Figure 103 - Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to earth of CLASS I EQUIPMENT caused by an external voltage on the FUNCTIONAL EARTH TERMINAL . 31 Figure 104 - Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PAR

28、T to EARTH Of INTERNALLY POWERED EQUIPMENT, caused by an external Voltage On a FUNCTIONAL EARTH TERMINAL 32 Figure 105 - Clarification of leakage current tests . 33 Figure 106 - Diaphragm leak test 34 Figure 107 - Over-pressure test 34 Figure 108 - Test layout for conducted and radiated emission and

29、 radiated immunity test 35 Figure 1 O9 - Test circuit for high-frequency surgery interference measurement, when the PATIENT isolation is in the monitor . 36 Figure I 1 O - Test circuit for HIGH-FREQUENCY surgery interference measurement, when the PATIENT Solation iS in the TRANSDUCER 37 Figure II 1

30、- Test Set-up for HIGH-FREQUENCY SURGICAL EQUIPMENT interference measurement . 38 Figure 112 - Test for accuracy of pressure measurements 39 Figure 11 3 - Test for sensitivity, repeatability, non-linearity, drift and hysteresis . 40 Figure 114 - Pressure measurement system for accuracy of systolic a

31、nd diastolic pressure 41 Figure 11 5 - Frequency response Of EQUIPMENT and TRANSDUCER . 42 Figure 116 - Test for ALARM DELAY 43 Figure 117 - Test for ALARM DELAY 44 Figure AA.l - Pressure TRANSDUCER error band 53 O BSI 04-2001 STD-BSI BS EN hb02-2-34-ENGL 2OOL Lb24bb9 0900930 O58 D Page 5 EN 60601-2

32、-34:2000 I NTROD UCTION The General Standard does not include requirements specific to the safety, including need to be made to include these unique requirements. This particular standard takes into account Collateral Standard 60607-7-2:(7993) Electromagnetic compatibility and Collateral Standard 60

33、601-7-4:(7996) Medical electrical equipment incorporating programmable electrical systems. A section on ALARMS has been included because ALARMS are necessary for essential perfortnance, Of DIRECT BLOOD PRESSURE MONITORING EQUIPMENT. Hence, changes MONITORING EQUIPMENT. O BSI 04-2001 STD=BSI BS EN 60

34、601-2-34-ENGL 2OOL 1624669 0900931 T94 Page 6 EN 60601-2-34:2000 MEDICAL ELECTRICAL EQUIPMENT - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment SECTION ONE -GENERAL The clauses and subclauses of this section of the G

35、eneral 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 Standard applies to INVASIVE BLOOD PRESSURE MONITORING and IneaSUrhg EQUIPMENT as defined in 2.1 01, hereinafter referred to as EQUIPMENT. T

36、his Particular Standard does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables. This PaI%CUIar Standard aIS0 does not apply to NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT. 1.2 Object Replacement: The object of this Particular Standard is to establish particular req

37、uirements for the safety, including the 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 7: General requirements for safety as amended by its amendment 1 (1991) and it

38、s amendment 2 (1 995). The General Standard takes into account IEC 60601 -1-2:1993, Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests and IEC 60601 -1 -4: 1996, Medical electrical equipment - Part 7

39、: Collateral Standard: Programmable electrical medical systems. For brevity, IEC 60601 is referred to in this Particular Standard either as the “General Standard” or as the “General Requirement(s)”. O BSI 04-2001 STD.BSI BS EN 60601-2-34-ENGL 2001 1b24bb9 0900932 920 m Page 7 EN 60601-2-34:2000 The

40、numbering of sections, clauses or 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: “Replacement“ means that the clause or subclause of the General Standard is replaced

41、completely by the text of this Particular Standard. “Addition“ means that the clause or subclause 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

42、Particular Standard. Subclauses or 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 Partic

43、ular Standard taken together. An asterisk (*) notes clauses for which there is rationale comment in annex AA or annex BB. It is considered that a knowledge of the reasons for these requirements will facilitate the proper application of the standard and be of use in any revision that may be necessita

44、ted by changes in clinical practice or as a result of developments in technology. 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; where it

45、 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 priority over those of the General Standard and of the Collateral Standards mention

46、ed above. 2 Terminology and definitions This clause of the General Standard applies except as follows: 2.1.5 APPLIED PART Replacement: The TRANSDUCER, including any fluid-filled system. Additional definitions: 2.101 stand-alone measuring equipment or part of a physiological monitoring or measuring s

47、ystem, including associated TRANSDUCERS, that is used for the internal measurement of circulatory system pressures INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (EQUIPMENT) O BSI 04-2001 STD-BSI BS EN bObOL-2-34-ENGL 2001 Lb24bb7 0900733 867 = Page 8 EN 60601-2-342000 2.102 device for converting pres

48、sure into an electrical signal for monitoring or measuring TRANSDUCER 2.103 TRANSDUCER mounted at, or close to, the tip of a catheter and intended for insertion into the cardiovascular system CATHETER TIP TRANSDUCER 2.104 DOME means for hydraulically coupling the PATIENTS blood pressure to the TRANS

49、DUCER, where a TRANSDUCER external to the PATIENT iS used 2.12.1 o1 ALARM signal which indicates abnormal events occurring to the PATIENT or EQUIPMENT 2.12.102 PHYSIOLOGICAL ALARM signal which either indicates that a monitored physiological parameter is out of specified limits or indicates an abnormal PATIENT condition 2.12.103 TECHNICAL ALARM signal which indicates that the EQUIPMENT or part(S) Of the EQUIPMENT are not capable Of accurately monitoring the PATIENTS condition 2.12.104 SILENCING stopping an auditory ALARM manifestation by manual action 2.1 2.1 05