EN IEC 60601-2-34:2024
(Main)Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
IEC 60601-2-34:2024 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as ME EQUIPMENT. This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT. This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME. This document does not apply to non-invasive blood pressure monitoring equipment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows: The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding safety measure or function is not completely integrated into the ME EQUIPMENT but implemented as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM. IEC 60601-2-34:2024 cancels and replaces the third edition of IEC 60601-2-34 published in 2011 and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision to align with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, as well as new versions of collateral standards and amendments thereto; b) expansion of the scope to the emergency medical service environment; c) changed essential performance in Table 201.101; d) changed requirement for ingress protection; e) added primary operating functions; f) deleted Annex BB Alarm diagrams.
Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von invasiven Blutdruck-Überwachungsgeräten
Appareils électromédicaux - Partie 2-34: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance de la pression sanguine prélevée directement
L'IEC 60601-2-34:2024 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE SURVEILLANCE DE LA PRESSION SANGUINE PRELEVEE DIRECTEMENT définis en 201.3.63, également désignés ci-après APPAREILS EM. Le présent document s’applique aux APPAREILS DE SURVEILLANCE DE LA PRESSION SANGUINE PRELEVEE DIRECTEMENT destinés à une utilisation dans des établissements de soins et dans l’ENVIRONNEMENT DES SERVICES MEDICAUX D’URGENCE. Le présent document ne s’applique pas aux tubes et aiguilles de cathéter, aux connecteurs Luer, et aux prises et panneaux de prises de connexion au DOME. Le présent document ne s’applique pas non plus aux appareils de surveillance de la pression sanguine prélevée indirectement. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, comme suit: L’article ou le paragraphe s’applique aux APPAREILS EM, par défaut et, uniquement si la fonction ou la mesure de sécurité correspondante n’est pas complètement intégrée dans l’APPAREIL EM mais mise en œuvre en tant que partie d’un SYSTEME EM, l’article ou le paragraphe s’applique au SYSTEME EM. L'IEC 60601-2-34:2024 annule et remplace la troisième édition de l’IEC 60601-2-34 parue en 2011 et constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l’édition précédente: a) révision pour aligner sur l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012 et l’IEC 60601-1:2005/AMD2:2020, ainsi que sur les nouvelles versions des normes collatérales et de leurs amendements; b) élargissement du domaine d’application à l’environnement des services médicaux d’urgence; c) modification de la performance essentielle du Tableau 201.101; d) modification de l’exigence relative à la protection contre la pénétration; e) ajout de fonctions principales de service; f) suppression de l’Annexe BB, schémas d’alarme.
Medicinska električna oprema - 2-34. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za invazivno nadzorovanje krvnega tlaka
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-34:2023
01-januar-2023
Medicinska električna oprema - 2-34. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za invazivno nadzorovanje krvnega tlaka
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and
essential performance of invasive blood pressure monitoring equipment
Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von invasiven Blutdruck-
Überwachungsgeräten
Amendement 1 - Appareils électromédicaux - Partie 2-34: Exigences particulières pour la
sécurité de base et les performances essentielles des appareils de surveillance de la
pression sanguine prélevée directement
Ta slovenski standard je istoveten z: prEN IEC 60601-2-34:2022
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
oSIST prEN IEC 60601-2-34:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN IEC 60601-2-34:2023
oSIST prEN IEC 60601-2-34:2023
62D/1990/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-34 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-11 2023-02-03
SUPERSEDES DOCUMENTS:
62D/1885/CD, 62D/1916A/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.
TITLE:
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment
PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
oSIST prEN IEC 60601-2-34:2023
62D/1990/CDV – 2 – IEC CD 60601-2-34 © IEC:2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 4
4 INTRODUCTION . 7
5 201.1 Scope, object and related standards . 8
6 201.2 Normative references . 10
7 201.3 Terms and definitions . 10
8 201.4 General requirements . 11
9 201.5 General requirements for testing of ME EQUIPMENT . 12
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
11 201.7 ME EQUIPMENT identification, marking and documents . 13
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 23
15 201.11 Protection against excessive temperatures and other HAZARDS . 23
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 25
17 201.13 HAZARDOUS SITUATIONS and fault conditions . 31
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31
19 201.15 Construction of ME EQUIPMENT . 31
20 201.16 ME SYSTEMS . 32
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 32
22 202 Electromagnetic disturbances – Requirements and tests . 32
23 208 General requirements, tests and guidance for alarm systems in MEDICAL
24 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 38
25 Annexes. 44
26 Annex AA (informative) Particular guidance and rationale . 45
27 Bibliography . 56
28 Index of defined terms used in this particular standard. 57
30 Figure 201.101 – Dynamic test for limitation of energy from different parts – Recovery
31 test . 17
32 Figure 201.102 – Diaphragm leak test . 18
33 Figure 201.103 – Measuring circuit for PATIENT LEAKAGE CURRENT via the PATIENT
34 CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
35 PATIENT CONNECTION(S) . 19
36 Figure 201.104 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
37 PART to earth of CLASS I ME EQUIPMENT caused by an external voltage on a metal
38 ACCESSIBLE PART that is not PROTECTIVELY EARTHED. . 20
39 Figure 201.105 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
40 PART to earth of INTERNALLY POWERED ME EQUIPMENT caused by an external voltage on
41 a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 21
42 Figure 201.106– Clarification of leakage current tests . 22
43 Figure 201.107 – Over-pressure test . 23
44 Figure 201.108 – Test for accuracy of pressure measurements . 27
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IEC CD 60601-2-34 © IEC:202X – 3 – 62D/xxxx/CDV
45 Figure 201.109 – Test sequence for sensitivity, repeatability, non-linearity, drift and
46 hysteresis . 28
47 Figure 201.110 – Pressure measurement system for accuracy of systolic and diastolic
48 pressure . 29
49 Figure 201.111 – Frequency response of ME EQUIPMENT and PRESSURE TRANSDUCER . 30
50 Figure 202.101 – Test layout for conducted and radiated EMISSION and radiated
51 immunity test . 33
52 Figure 202.102 – Test circuit for high-frequency surgery interference measurement,
53 when the isolation of the APPLIED PART is in the monitor . 36
54 Figure 202.103 – Test circuit for high-frequency surgery protection, when the isolation
55 of the APPLIED PART is in the PRESSURE TRANSDUCER . 36
56 Figure 202.104 – Test set-up for high-frequency surgery protection . 37
57 Figure 208.101 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
58 ALARM CONDITIONS . 41
59 Figure 208.102 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
60 ALARM CONDITIONS . 42
61 Figure AA.1 – PRESSURE TRANSDUCER error band . 52
63 Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
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62D/1990/CDV – 4 – IEC CD 60601-2-34 © IEC:2022
66 INTERNATIONAL ELECTROTECHNICAL COMMISSION
67 ____________
69 MEDICAL ELECTRICAL EQUIPMENT –
71 Part 2-34: Particular requirements for the basic safety and essential
72 performance of invasive blood pressure monitoring equipment
75 FOREWORD
76 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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107 indispensable for the correct application of this publication.
108 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
109 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
110 International standard IEC 60601-2-34 has been prepared by a Joint Working Group of IEC
111 subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
112 equipment in medical practice and ISO subcommittee SC3: Lung ventilators and related
113 equipment, of ISO technical committee 121: Anaesthetic and respiratory equipment.
114 This fourth edition cancels and replaces the third edition of IEC 60601-2-34 published in 2011
115 and constitutes a technical revision. This edition was revised to align with Amendment 1:2012
116 and Amendment 2:2020 of IEC 60601-1:2005 as well as new versions of collateral standards
117 and amendments thereto.
118 Further it includes the following technical changes:
119 – Expansion of the scope to the EMERGENCY MEDICAL SERVICE ENVIRONMENT
120 – Changed ESSENTIAL PERFORMANCE in Table 201.101
121 – Changed requirement for ingress protection
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IEC CD 60601-2-34 © IEC:202X – 5
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