EN IEC 60601-2-37:2024
(Main)Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME 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 relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx, b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
IEC 60601-2-37:2024 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-37:2024 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DE DIAGNOSTIC A ULTRASONS comme cela est défini en 201.3.217, désignés ci-après sous le terme APPAREILS EM. Si un article ou un paragraphe est destiné spécifiquement 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, selon le cas. Les DANGERS inhérents à la fonction physiologique prévue de l'APPAREIL EM ou du SYSTEME EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception du 201.7.2.13. Le présent document ne couvre pas les appareils thérapeutiques à ultrasons. Les appareils utilisés pour réaliser l'imagerie ou le diagnostic de structures du corps par ultrasons, en association avec une autre procédure médicale, sont couverts. L'IEC 60601-2-37:2024 annule et remplace la deuxième édition parue en 2007, et l’Amendement 1:2015. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) modifications techniques et rédactionnelles, qui résultent de la norme générale amendée IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 et IEC 60601-1:2005/AMD2:2020 et de ses normes collatérales IEC 60601-1-xx ; b) modifications techniques et rédactionnelles qui résultent de la maintenance des références normatives ; c) modifications techniques et rédactionnelles qui résultent des évolutions correspondantes des normes du CE 87 Ultrasons. En particulier, l’Article 201.11 concernant la protection contre les températures excessives et les autres dangers a été entièrement révisé.
Medicinska električna oprema - 2-37. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ultrazvočne medicinske diagnostične in nadzorovalne opreme (IEC 60601-2-37:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2025
Medicinska električna oprema - 2-37. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ultrazvočne medicinske diagnostične in nadzorovalne opreme
(IEC 60601-2-37:2024)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC
60601-2-37:2024)
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die
medizinische Diagnose und Überwachung (IEC 60601-2-37:2024)
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de diagnostic et de surveillance médicaux
à ultrasons (IEC 60601-2-37:2024)
Ta slovenski standard je istoveten z: EN IEC 60601-2-37:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-37
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2024
ICS 11.040.55; 17.140.50 Supersedes EN 60601-2-37:2008; EN 60601-2-
37:2008/A11:2011; EN 60601-2-37:2008/A1:2015
English Version
Medical electrical equipment - Part 2-37: Particular requirements
for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
(IEC 60601-2-37:2024)
Appareils électromédicaux - Partie 2-37: Exigences Medizinische elektrische Geräte - Teil 2-37: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de diagnostic et de surveillance wesentlichen Leistungsmerkmale von Ultraschallgeräten für
médicaux à ultrasons die medizinische Diagnose und Überwachung
(IEC 60601-2-37:2024) (IEC 60601-2-37:2024)
This European Standard was approved by CENELEC on 2024-10-16. 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 60601-2-37:2024 E
European foreword
The text of document 62B/1318/CDV, future edition 3 of IEC 60601-2-37, prepared by SC 62B
"Medical imaging 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) 2025-11-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-11-30
document have to be withdrawn
This document supersedes EN 60601-2-37:2008 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 60601-2-37:2024 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 61157:2007 NOTE Approved as EN 61157:2007 (not modified)
IEC 61157:2007/A1:2013 NOTE Approved as EN 61157:2007/A1:2013 (not modified)
IEC 60601-1-11:2015 NOTE Approved as EN 60601-1-11:2015 (not modified)
IEC 60601-1-11:2015/A1:2020 NOTE Approved as EN 60601-1-11:2015/A1:2021 (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.
Clause 2 of EN 60601-1:2006, 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 and EN 60601-1:2006/A13:2024 is applicable, except as follows:
Add the following references:
Publication Year Title EN/HD Year
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 60601-2-18 2009 Medical electrical equipment - Part 2-18: EN 60601-2-18 2015
Particular requirements for the basic safety
and essential performance of endoscopic
equipment
IEC 62127-1 2022 Ultrasonics - Hydrophones - Part 1: EN IEC 62127-1 2022
Measurement and characterization of
medical ultrasonic fields
Publication Year Title EN/HD Year
IEC 62359 2010 Ultrasonics - Field characterization - Test EN 62359 2011
methods for the determination of thermal
and mechanical indices related to medical
diagnostic ultrasonic fields
+ A1 2017 + A1 2018
CISPR 11 2024 Industrial, scientific and medical equipment - EN 55011 —
Radio-frequency disturbance characteristics
- Limits and methods of measurement
Under preparation. Stage at the time of publication: FprEN 55011:2023.
IEC 60601-2-37 ®
Edition 3.0 2024-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-37: Particular requirements for the basic safety and essential performance
of ultrasonic medical diagnostic and monitoring equipment
Appareils électromédicaux –
Partie 2-37: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55, 17.140.50 ISBN 978-2-8322-8920-4
– 2 – IEC 60601-2-37:2024 © 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 . 10
201.4 General requirements . 17
201.5 General requirements for testing ME EQUIPMENT . 18
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
201.7 ME EQUIPMENT identification, marking and documents . 18
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 23
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 . 29
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 . 31
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 31
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment
(EMS) . 33
Annexes . 34
Annex AA (informative) Particular guidance and rationale . 35
Annex BB (informative) Guidance in classification according to CISPR 11 . 43
Annex CC (informative) Guidance to the MANUFACTURER on the interpretation of TI and
MI to be used to inform the OPERATOR . 44
Annex DD (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES . 48
Annex EE (informative) Acoustic output table intended for third parties . 51
Bibliography . 54
Index of defined terms . 58
Figure AA.1 – Method a) for an external probe . 38
Figure AA.2 – Method b) for an external probe . 39
Figure AA.3 – Method b) for an external probe . 39
Figure DD.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers . 50
Table 201.101 – List of symbols . 16
Table 201.102 – Distributed essential performance requirements . 18
IEC 60601-2-37:2024 © IEC 2024 – 3 –
Table 201.103 – Acoustic output reporting table . 22
Table 201.104 – Overview of the tests noted under 201.11.1.3 . 28
Table CC.1 – Relative importance of maintaining low exposure indices in various
scanning situations . 46
Table DD.1 – Acoustic and thermal properties of tissues and materials . 48
Table DD.2 – Weight % pure components . 49
Table EE.1 – Example of ac
...
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