oSIST prEN IEC 60601-2-37:2023
(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 is available as IEC 60601-2-37:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
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 est disponible sous forme de 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
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2023
Medicinska električna oprema - 2-37. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ultrazvočne medicinske diagnostične in nadzorovalne opreme
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment
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
Ta slovenski standard je istoveten z: prEN IEC 60601-2-37:2023
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.
62B/1318/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-37 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-06-16 2023-09-08
SUPERSEDES DOCUMENTS:
62B/1295/CD, 62B/1304A/CC
IEC SC 62B : MEDICAL IMAGING EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
TC 87
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
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Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clau ses
to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC
clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment
PROPOSED STABILITY DATE: 2026
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.
62B/1318/CDV – 2 – CDV IEC 60601-2-37 © IEC 2023
NOTE FROM TC/SC OFFICERS:
62B/1318/CDV – 3 – CDV IEC 60601-2-37 © IEC 2023
1 CONTENTS
2 CONTENTS . 1
3 FOREWORD . 4
4 INTRODUCTION . 6
5 INTRODUCTION TO AMENDMENT 1 . 6
6 INTRODUCTION TO EDITION 3 . 6
7 201.1Scope, object and related standards . 7
8 201.2Normative references . 8
9 201.3Terms and definitions . 9
10 201.4General requirements . 15
11 201.5General requirements for testing ME EQUIPMENT . 15
12 201.6Classification of ME EQUIPMENT and ME SYSTEMS . 16
13 201.7ME EQUIPMENT identification, marking and documents . 16
14 201.8Protection against electrical HAZARDS from ME EQUIPMENT . 20
15 201.9Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
16 201.10Protection against unwanted and excessive radiation HAZARDS . 20
17 201.11Protection against excessive temperatures and other HAZARDS . 21
18 201.12Accuracy of controls and instruments and protection against hazardous outputs . 25
19 201.13HAZARDOUS SITUATIONS and fault conditions . 27
20 201.14PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
21 201.15Construction of ME EQUIPMENT . 28
22 201.16ME SYSTEMS . 28
23 201.17*Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 28
24 212Requirements for medical electrical equipment and medical electrical systems
25 intended for use in the emergency medical services environment (EMS) . 29
26 Annex AA (informative) . 31
27 Index of defined terms . 54
29 Figure DD.1 – Set-up of an example test object to measure the surface temperature of
30 externally applied transducers . 46
32 Table 201.101 – List of symbols . 14
33 Table 201.102 – Distributed essential performance requirements . 15
34 Table 201.103 – Acoustic output reporting table . 19
35 Table 201.104 – Overview of the tests noted under 201.11.1.3 . 25
36 Table CC.1 – Relative importance of maintaining low exposure indices in various
37 scanning situations . 43
38 Table DD.1 – Acoustic and thermal properties of tissues & materials . 44
39 Table DD.2 – Weight % pure components . 45
62B/1318/CDV – 4 – CDV IEC 60601-2-37 © IEC 2023
42 INTERNATIONAL ELECTROTECHNICAL COMMISSION
43 ______________
45 MEDICAL ELECTRICAL EQUIPMENT –
47 Part 2-37: Particular requirements for the basic safety
48 and essential performance of ultrasonic medical
49 diagnostic and monitoring equipment
52 FOREWORD
53 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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81 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
82 indispensable for the correct application of this publication.
83 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
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DISCLAIMER
This Consolidated version is not an official IEC Standard and has been prepared for user
convenience. Only the current versions of the standard and its amendment(s) are to be
considered the official documents.
85 This Consolidated version of IEC 60601-2-37 bears the edition number 2.1. It consists of
86 the second edition (2007-08) [documents 62B/624/CDV and 62B/657/RVC] and its
87 amendment 1 (2015-06) [documents 62B/978/FDIS and 62B/988/RVD]. The technical
88 content is identical to the base edition and its amendment.
89 This Final version does not show where the technical content is modified by amendment
90 1. A separate Redline version with all changes highlighted is available in this publication.
91 International standard IEC 60601-2-37 has been prepared by IEC subcommittee 62B: Medical
92 imaging equipment, software, and systems, of IEC technical committee 62: Medical equipment,
93 software, and systems.
62B/1318/CDV – 5 – CDV IEC 60601-2-37 © IEC 2023
94 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
95 In this standard, the following print types are used:
96 – Requirements and definitions: roman type.
97 – Test specifications: italic type.
98 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
99 Normative text of tables is also in a smaller type.
100 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
101 NOTED: SMALL CAPITALS.
102 In referring to the structure of this standard, the term
103 – “clause” means one of the seventeen numbered divisions within the table of contents,
104 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
105 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
106 subclauses of Clause 7).
107 References to clauses within this standard are preceded by the term “Clause” followed by the
108 clause number. References to subclauses within this particular standard are by number only.
109 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
110 combination of the conditions is true.
111 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
112 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
113 – “shall” means that compliance with a requirement or a test is mandatory for compliance with
114 this standard;
115 – “should” means that compliance with a requirement or a test is recommended but is not
116 mandatory for compliance with this standard;
117 – “may” is used to describe a permissible way to achieve compliance with a requirement or
118 test.
119 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
120 indicates that there is guidance or rationale related to that item in Annex AA.
121 A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
122 equipment, can be found on the IEC website
123 Th
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