BS EN 60601-2-34-2001 Medical electrical equipment - Particular requirements for safety - Particular requirements for the safety including essential performance of invasive blood p.pdf

1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 60601-2-34:2001 IEC

2、 60601-2-34:2000 The European Standard EN 60601-2-34:2000 has the status of a British Standard ICS 11.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Medical electrical equipment Part 2-34: Particular requirements for the safety, including essential performance, of inva

3、sive blood pressure monitoring equipmentThis British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 April 2001 BSI 04-2001 ISBN 0 580 36773 8 BS EN 60601-2-34:

4、2001 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the official English language version of EN 60601-2-34:2000. It is identical with IEC 60601-2-34:2000. It supersedes BS EN 60601-2-34:1994 which is withdrawn. The UK participation in its prepar

5、ation was entrusted to Technical Committee CH/96, Monitoring equipment, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;

6、 monitor related international 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 h

7、as been renumbered 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. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normativ

8、e references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by u

9、sing 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 application. Compliance with a British Standard does not of itself confer immuni

10、ty 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 document indicates when the document was last issued.EUROPEAN STANDARD EN 6060

11、1-2-34 NORME EUROPENNE EUROPISCHE NORM December 2000 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 2000 CENELEC - All rights o

12、f exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-34:2000 E ICS 11.040.55 Supersedes EN 60601-2-34:1995 English version Medical electrical equipment Part 2-34: Particular requirements for the safety, including essential performance, of invasive b

13、lood pressure monitoring equipment (IEC 60601-2-34:2000) Appareils lectromdicaux Partie 2-34: Rgles particulires de scurit pour les appareils de surveillance de la pression sanguine prleve directement (CEI 60601-2-34:2000) Medizinische elektrische Gerte Teil 2-34: Besondere Festlegungen fr die Siche

14、rheit einschlielich wesentlicher Leistungsmerkmale, von invasiven Blutdruck-berwachungsgerten (IEC 60601-2-34:2000) This European Standard was approved by CENELEC on 2000-11-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving th

15、is 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 three official versio

16、ns (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 electrotechnical committees of A

17、ustria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Foreword The text of document 62D/367/FDIS, future edition 2 of IEC 60601-2-34, prepared by SC 62D, Electromed

18、ical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-34 on 2000-11-01. This European Standard supersedes EN 60601-2-34:1995. The following dates were fixed: latest date by which the EN has to

19、be implemented at national level by publication of an identical national standard or by endorsement (dop) 2001-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2003-11-01 Annexes designated “normative“ are part of the body of the standard. Annexes

20、designated “informative“ are given for information only. In this standard, annexes AA and BB are informative. _ Endorsement notice The text of the International Standard IEC 60601-2-34:2000 was approved by CENELEC as a European Standard without any modification. _ Page2 EN60601234:2000 BSI 04-2001 C

21、ONTENTS Page INTRODUCTION 5 Clause SECTION ONE GENERAL 1 Scope and object. 6 2 Terminology and definitions . 7 4 General requirements for tests. 9 5 Classification . 9 6 Identification, marking and documents . 9 SECTION TWO ENVIRONMENTAL CONDITIONS SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZ

22、ARDS 14 Requirements related to classification.10 17 Separation11 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 11 20 Dielectric strength.12 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength12 SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE

23、RADIATION 36 ELECTROMAGNETIC COMPATIBILITY.13 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS 42 Excessive temperatures16 44 Overflow, spillage, leakage, humidity, ingress of liquids

24、, cleaning, sterilization, disinfection and compatibility 16 45 Pressure vessel and parts subject to pressure17 46 Humman errors.18 SECTION EIGHT ACCURACY OF OPERATION DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data .18 51 Protection against hazardous output.18 SECTION NIN

25、E ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS SECTION TEN CONSTRUCTIONAL REQUIREMENTS 56 Components and general assembly 28 57 Mains parts, components and layout.28 Page3 EN60601234:2000 BSI 04-2001 Annex AA (informative) Guidance and rationale for particular clauses and subclauses4

26、5 Annex BB (informative) ALARM diagrams .54 INDEX of defined terms 57 Bibliography58 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 different parts Reco

27、very 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 PART to EARTH of INTERNALLY P

28、OWERED EQUIPMENT, caused by an external voltage on a FUNCTIONAL EARTH TERMINAL32 Figure 105 Clarification of leakage current tests.33 Figure 106 Diaphragm leak test34 Figure 107 Over-pressure test34 Figure 108 Test layout for conducted and radiated emission and radiated immunity test 35 Figure 109 T

29、est circuit for high-frequency surgery interference measurement, when the PATIENT isolation is in the monitor.36 Figure 110 Test circuit for HIGH-FREQUENCY surgery interference measurement, when the PATIENT isolation is in the TRANSDUCER 37 Figure 111 Test set-up for HIGH-FREQUENCY SURGICAL EQUIPMEN

30、T interference measurement.38 Figure 112 Test for accuracy of pressure measurements39 Figure 113 Test for sensitivity, repeatability, non-linearity, drift and hysteresis.40 Figure 114 Pressure measurement system for accuracy of systolic and diastolic pressure41 Figure 115 Frequency response of EQUIP

31、MENT and TRANSDUCER.42 Figure 116 Test for ALARM DELAY 43 Figure 117 Test for ALARM DELAY 44 Figure AA.1 Pressure TRANSDUCER error band53 Page4 EN60601234:2000 BSI 04-2001 INTRODUCTION The General Standard does not include requirements specific to the safety, including essential performance, of DIRE

32、CT BLOOD PRESSURE MONITORING EQUIPMENT. Hence, changes need to be made to include these unique requirements. This particular standard takes into account Collateral Standard 60601-1-2:(1993) Electromagnetic compatibility and Collateral Standard 60601-1-4:(1996) Medical electrical equipment incorporat

33、ing programmable electrical systems. A section on ALARMS has been included because ALARMS are necessary for MONITORING EQUIPMENT. Page5 EN60601234:2000 BSI 04-2001 MEDICAL ELECTRICAL EQUIPMENT Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood press

34、ure 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 Particular Standard applies to INVASIVE BLOOD PRESSURE

35、MONITORING and measuring EQUIPMENT as defined in 2.101, hereinafter referred to as EQUIPMENT. This Particular Standard does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables. This Particular Standard also does not apply to NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMEN

36、T. 1.2 Object Replacement: The object of this Particular Standard is to establish particular requirements 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

37、equipment Part 1: General requirements for safety as amended by its amendment 1 (1991) and its amendment 2 (1995). 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 Re

38、quirements and tests and IEC 60601-1-4:1996, Medical electrical equipment Part 1: 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)”. Page6 EN60601234:2000

39、 BSI 04-2001 The 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 Stan

40、dard is replaced 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

41、the text of this 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 Standar

42、d and this Particular 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

43、 may be necessitated 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 modif

44、ication; 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 priority over those of the General Standard and of the Collateral

45、Standards mentioned 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 INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT (EQUIPMENT) stand-alon

46、e measuring equipment or part of a physiological monitoring or measuring system, including associated TRANSDUCERS, that is used for the internal measurement of circulatory system pressures Page7 EN60601234:2000 BSI 04-2001 2.102 TRANSDUCER device for converting pressure into an electrical signal for

47、 monitoring or measuring 2.103 CATHETER TIP TRANSDUCER TRANSDUCER mounted at, or close to, the tip of a catheter and intended for insertion into the cardiovascular system 2.104 DOME means for hydraulically coupling the PATIENTS blood pressure to the TRANSDUCER, where a TRANSDUCER external to the PAT

48、IENT is used 2.12.101 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

49、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 2.12.105 SILENCING/RESET stopping a visual and/or auditory ALARM manifestation and reenabling system response to an abnormal PATIENT condition 2.12.106 INHIBITION disabling or SILENCING and disabling an ALARM until revoked int