IEC 60601-2-37:2007

IEC 60601-2-37
Edition 2.0 2007-08
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
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IEC 60601-2-37
Edition 2.0 2007-08
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
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.55; 17.140.50 ISBN 2-8318-9266-X

– 2 – 60601-2-37 © IEC:2007
CONTENTS
FOREWORD.4
INTRODUCTION.6

201.1 Scope, object and related standards .7
201.2 Normative references.8
201.3 Terminology and definitions .8
201.4 General requirements.11
201.5 General requirements for testing ME EQUIPMENT .12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .12
201.7 ME EQUIPMENT identification, marking and documents .12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.16
201.10 Protection against unwanted and excessive radiation HAZARDS .16
201.11 Protection against excessive temperatures and other HAZARDS .17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .21
201.13 Hazardous situations and fault conditions .22
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .23
201.15 Construction of ME EQUIPMENT .23
201.16 ME SYSTEMS.23
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .23
202.6 ELECTROMAGNETIC COMPATIBILITY .23

Annex AA (informative) Guidance and rationale for particular subclauses .26
Annex BB (informative) Guidance in classification according to CISPR 11 .31
Annex CC (informative) Guidance to the MANUFACTURER on the interpretation of TI and
MI to be used to inform the OPERATOR.32
Annex DD (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES .35

Bibliography.38

Index of defined terms .41

Figure DD.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers .37

Table 201.101 – List of symbols.11
Table 201.102 – Distributed essential performance requirements .12
Table 201.103 –Acoustic output reporting table .15
Table 201.104 – Overview of the tests noted under 201.11.1.3 .20
Table CC.1 – Relative importance of maintaining low exposure indices in various
scanning situations .34

60601-2-37 © IEC:2007 – 3 –
Table DD.1 – Acoustic and thermal properties of tissues & materials .35
Table DD.2 – Weight % pure components .36

– 4 – 60601-2-37 © IEC:2007
INTERNATIONAL ELECTROTECHNICAL COMMISSION
______________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-37: Particular requirements for the basic safety
and essential performance of ultrasonic medical
diagnostic and monitoring equipment

FOREWORD
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International standard IEC 60601-2-37 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 2001 and its
Amendment 1 (2004) and Amendment 2 (2005). This edition combines the previous edition
and its amendments into a form compatible with the parent IEC 60601-1:2005.
The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62B/624/CDV 62B/657/RVC
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.

60601-2-37 © IEC:2007 – 5 –
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
ERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
– T
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
...