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.
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.
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IEC 60601-2-34 ®
Edition 4.0 2024-10
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 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
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IEC 60601-2-34 ®
Edition 4.0 2024-10
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 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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-9681-3
– 2 – IEC 60601-2-34:2024 © IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 26
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 31
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 ME SYSTEMS . 32
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 32
202 Electromagnetic disturbances – Requirements and tests . 33
206 USABILITY . 38
208 General requirements, tests and guidance for alarm systems in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 39
Annexes . 46
Annex AA (informative) Particular guidance and rationale . 47
Bibliography . 58
Index of defined terms used in this particular standard . 59
Figure 201.101 – Dynamic test for limitation of energy from different parts – Recovery
test 17
Figure 201.102 – Diaphragm leak test . 18
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). 19
Figure 201.104 – Measuring circuit for the PATIENT 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 . 20
Figure 201.105 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of INTERNALLY POWERED ME EQUIPMENT caused by an external voltage on
a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 21
Figure 201.106 – Clarification of leakage current tests . 22
Figure 201.107 – Over-pressure test . 23
Figure 201.108 – Test for accuracy of pressure measurements. 27
Figure 201.109 – Test sequence for sensitivity, repeatability, non-linearity, drift and
hysteresis . 28
Figure 201.110 – Pressure measurement system for accuracy of systolic and diastolic
pressure . 29
Figure 201.111 – Frequency response of ME EQUIPMENT and PRESSURE TRANSDUCER . 30
Figure 202.101 – Test layout for conducted and radiated EMISSION and radiated
immunity test . 34
Figure 202.102 – Test circuit for high-frequency surgery interference measurement,
when the isolation of the APPLIED PART is in the monitor . 36
Figure 202.103 – Test circuit for high-frequency surgery protection, when the isolation
of the APPLIED PART is in the PRESSURE TRANSDUCER . 37
Figure 202.104 – Test set-up for high-frequency surgery protection . 38
Figure 208.101 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
ALARM CONDITIONS . 42
Figure 208.102 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
ALARM CONDITIONS . 43
Figure AA.1 – PRESSURE TRANSDUCER error band . 54
Table 201.101 – ESSENTIAL PERFORMANCE requirements. 12
– 4 – IEC 60601-2-34:2024 © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment
FOREWORD
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