IEC 60601-2-34-2011 Medical electrical equipment - Part 2-34 Particular requirements for the basic safety and essential performance of invasive blood pressure m.pdf

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1、 IEC 60601-2-34 Edition 3.0 2011-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment Appareils lectromdicaux Partie 2-34: Exigences particulires p

2、our la scurit de base et les performances essentielles des appareils de surveillance de la pression sanguine prleve directement IEC 60601-2-34:2011 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2011 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publica

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17、RNATIONALE Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment Appareils lectromdicaux Partie 2-34: Exigences particulires pour la scurit de base et les performances essentielles des appareils

18、de surveillance de la pression sanguine prleve directement INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040.55 PRICE CODE CODE PRIX ISBN 978-2-88912-495-4 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commis

19、sion Electrotechnique Internationale 2 60601-2-34 IEC:2011 CONTENTS FOREWORD . 4 INTRODUCTION . 6 201.1 Scope, object and related standards . 7 201.2 Normative references 8 201.3 Terms and definitions 9 201.4 General requirements 10 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 C

20、lassification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents 11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 20 201.10 Protection against unwanted and excessive

21、radiation HAZARDS 21 201.11 Protection against excessive temperatures and other HAZARDS 21 201.12 Accuracy of controls and instruments and protection against hazardous outputs 23 201.13 HAZARDOUS SITUATIONS and fault conditions . 29 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 29 201.15 C

22、onstruction of ME EQUIPMENT . 29 201.16 ME SYSTEMS 30 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30 202 Electromagnetic compatibility Requirements and tests . 30 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical elec

23、trical systems 36 Annexes . 45 Annex AA (informative) Particular guidance and rationale 46 Annex BB (informative) Alarm diagrams 208/IEC 60601-1-8:2006 59 Bibliography 61 Index of defined terms used in this particular standard 62 Figure 201.101 Dynamic test for limitation of energy from different pa

24、rts Recovery test 15 Figure 201.102 Diaphragm leak test . 16 Figure 201.103 Measuring circuit for PATIENT LEAKAGE CURRENT via the PATIENT CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the PATIENT CONNECTION(S) . 17 Figure 201.104 Measuring circuit for the PATIENT

25、LEAKAGE CURRENT from the APPLIED PART to earth of CLASS I ME EQUIPMENT caused by an external voltage on a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED. 18 Figure 201.105 Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to earth of INTERNALLY POWERED ME EQUIPMENT caus

26、ed by an external voltage on a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 19 Figure 201.106 Clarification of leakage current tests . 20 Figure 201.107 Over-pressure test . 21 Figure 201.108 Test for accuracy of pressure measurements 25 60601-2-34 IEC:2011 3 Figure 201.109 Test sequence

27、 for sensitivity, repeatability, non-linearity, drift and hysteresis . 26 Figure 201.110 Pressure measurement system for accuracy of systolic and diastolic pressure . 27 Figure 201.111 Frequency response of ME EQUIPMENT and TRANSDUCER . 28 Figure 202.101 Test layout for conducted and radiated emissi

28、on and radiated immunity test 31 Figure 202.102 Test circuit for high-frequency surgery interference measurement, when the isolation of the APPLIED PART is in the monitor 34 Figure 202.103 Test circuit for high-frequency surgery protection, when the isolation of the APPLIED PART is in the TRANSDUCER

29、 35 Figure 202.104 Test set-up for high-frequency surgery protection 36 Figure 208.101 Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL ALARM CONDITIONS . 41 Figure 208.102 Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL ALARM CONDITIONS . 42 Figure AA.1 Pressure TRANSDU

30、CER error band . 53 Figure BB.101 NON-LATCHING ALARM SIGNALS without ALARM RESET . 59 Figure BB.102 NON-LATCHING ALARM SIGNALS with ALARM RESET 59 Figure BB.103 LATCHING ALARM SIGNALS with ALARM RESET . 60 Figure BB.104 Two ALARM CONDITIONS with ALARM RESET 60 Table 201.101 ESSENTIAL PERFORMANCE req

31、uirements . 10 Table 208.101 ALARM CONDITION priorities 37 Table 208.102 Characteristics of the BURST of auditory ALARM SIGNALS . 38 4 60601-2-34 IEC:2011 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Part 2-34: Particular requirements for the basic safety and essential pe

32、rformance of invasive blood pressure monitoring equipment FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-op

33、eration on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to

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39、endent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No l

40、iability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (i

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42、 of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. International standard IEC 60601-2-34 has been prepared by IEC subcom

43、mittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This third edition cancels and replaces the second edition of IEC 60601-2-34 published in 2001 and constitutes a technical revision. This edition was revised to align structurally with the

44、2005 edition of IEC 60601-1. The text of this particular standard is based on the following documents: FDIS Report on voting 62D/906/FDIS 62D/923/RVD Full information on the voting for the approval of this particular standard can be found in the report on voting indicated in the above table. 60601-2

45、-34 IEC:2011 5 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examp

46、les and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered d

47、ivisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term

48、“Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used in this standard conform

49、 to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to des