SIST EN IEC 60601-2-34:2025

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)

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 (IEC 60601-2-34:2024)

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 (IEC 60601-2-34:2024)

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 (IEC 60601-2-34:2024)

General Information

• Status: Published
• Public Enquiry End Date: 31-Jan-2023
• Publication Date: 12-Jan-2025
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 06-Jan-2025
• Due Date: 13-Mar-2025
• Completion Date: 13-Jan-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: EN IEC 60601-2-34:2024 - Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

Relations

• Revised: SIST EN 60601-2-34:2014 - Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
• Effective Date: 26-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2025
Medicinska električna oprema - 2-34. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za invazivno nadzorovanje krvnega tlaka (IEC 60601-2-
34:2024)
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)
Medizinische elektrische Geräte - Teil 2-34: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von invasiven Blutdruck-
Überwachungsgeräten (IEC 60601-2-34:2024)
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 (IEC 60601-2-34:2024)
Ta slovenski standard je istoveten z: EN IEC 60601-2-34:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-34

NORME EUROPÉENNE
EUROPÄISCHE NORM December 2024
ICS 11.040.55 Supersedes EN 60601-2-34:2014
English Version
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)
Appareils électromédicaux - Partie 2-34: Exigences Medizinische elektrische Geräte - Teil 2-34: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance de la pression wesentlichen Leistungsmerkmale von invasiven Blutdruck-
sanguine prélevée directement Überwachungsgeräten
(IEC 60601-2-34:2024) (IEC 60601-2-34:2024)
This European Standard was approved by CENELEC on 2024-11-29. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions 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 CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-34:2024 E

European foreword
The text of document 62D/2155/FDIS, future edition 4 of IEC 60601-2-34, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2025-12-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-12-31
document have to be withdrawn
This document supersedes EN 60601-2-34:2014 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-34:2024 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 80601-2-30 NOTE Approved as EN IEC 80601-2-30
IEC 60601-1-3 NOTE Approved as EN 60601-1-3
IEC 60601-1-9 NOTE Approved as EN 60601-1-9
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
IEC 62366-1:2015 NOTE Approved as EN 62366-1:2015 (not modified)
IEC 60601-2-2:2017 NOTE Approved as EN IEC 60601-2-2:2018 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Annex ZA of EN 60601-1:2006 is applicable, except as follows.
Replace:
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020 + A1 2021
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral standard:
Usability
+ A1 2013 + A1 2015
+ A2 2020 + A2 2021
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
General requirements for basic safety and
essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A11 2017
+ A2 2020 + A2 2021
As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
Publication Year Title EN/HD Year
ISO 15223-1 2021 Medical devices - Symbols to be used with EN ISO 15223-1 2021
information to be supplied by the
manufacturer - Part 1: General
requirements
Add:
Publication Year Title EN/HD Year
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
- - + AC 1993
+ A1 1999 + A1 2000
+ A2 2013 + A2 2013
- - + AC 2016-12
- - + AC 2019-02
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 60601-1-12 2014 Medical electrical equipment - Part 1-12: EN 60601-1-12 2015
General requirements for basic safety and
essential performance - Collateral Standard:
Requirements for medical electrical
equipment and medical electrical systems
intended for use in the emergency medical
services environment
+ A1 2020 + A1 2020
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

IEC 60601-2-34:2024 © IEC 2024 – 3 –
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 .
...