IEC 60601-2-5:2009

Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

This Particular Standard specifies requirements and tests for the safety of ultrasonic physiotherapy equipment. It amends and supplements IEC 60601-1 (second edition, 1988) including Amendments 1 and 2, hereinafter referred to as the General Standard. This Particular Standard takes into account IEC 60601-1-2 and IEC 61689.

Appareils électromédicaux - Partie 2-5: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à ultrasons pour physiothérapie

General Information

• Status: Published
• Publication Date: 29-Jul-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 18 - TC 62/SC 62D/MT 18
• Current Stage: PPUB - Publication issued
• Start Date: 15-Sep-2009
• Completion Date: 30-Jul-2009

Relations

• Revises: IEC 60601-2-5:2000 - Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-5 ®
Edition 3.0 2009-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-5: Particular requirements for the basic safety and essential performance
of ultrasonic physiotherapy equipment

Appareils électromédicaux –
Partie 2-5: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à ultrasons pour physiothérapie

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IEC 60601-2-5 ®
Edition 3.0 2009-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-5: Particular requirements for the basic safety and essential performance
of ultrasonic physiotherapy equipment

Appareils électromédicaux –
Partie 2-5: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils à ultrasons pour physiothérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
V
CODE PRIX
ICS 11.040.60 ISBN 978-2-88910-214-3
– 2 – 60601-2-5 © IEC:2009
CONTENTS
FOREWORD.0H3
INTRODUCTION.1H6
201.1 Scope, object and related standards .2H7
201.2 Normative references.3H9
201.3 Terms and definitions.4H9
201.4 General requirements.5H12
201.5 General requirements for testing of ME EQUIPMENT.6H13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .7H13
201.7 *ME EQUIPMENT identification, marking and documents .8H13
201.8 *Protection against electrical HAZARDS from ME EQUIPMENT .9H14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .10H15
201.10 Protection against unwanted and excessive radiation HAZARDS.11H15
201.11 Protection against excessive temperatures and other HAZARDS.12H16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.13H19
201.13 HAZARDOUS SITUATIONS and fault conditions.14H21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .15H21
201.15 Construction of ME EQUIPMENT .16H21
201.16 ME SYSTEMS .17H22
201.17 *Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .18H22
202 Electromagnetic compatibility – Requirements and tests .19H22
Annexes .20H23
Annex AA (informative) Particular guidance and rationale.21H24
Annex BB (informative) Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES .22H29
Bibliography.23H32
Index of defined terms used in this particular standard.24H33

Figure BB.1 – Set-up of an example test object to measure the surface temperature of
externally applied transducers .25H31

Table 201.101 – List of symbols.26H12
Table 201.102 – Distributed ESSENTIAL PERFORMANCE requirements .27H13
Table 201.103 – Overview of the tests noted under 201.11.1.3 .28H19
Table BB.1 – Acoustic and thermal properties of tissues and materials .29H29
Table BB.2 – Weight % pure components .30H30

60601-2-5 © IEC:2009 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-5: Particular requirements for the basic safety and essential
performance of ultrasonic physiotherapy equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-5 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 2000. This edition
constitutes a technical revision.
The numbering was revised to agree with IEC 60601-1:2005 (third edition). Beyond this,
essential performance characteristics are defined in 201.4.3.101, guidance on maintenance is
added in 201.7.9.2.1, a new requirement regarding dielectric withstand was added in
201.8.8.3. The clause on transducer surface temperature rise, 201.11, has been modified to
allow for simulated use conditions. Measurements of ultrasound-related parameters are now
referenced to IEC 61689:2007 (second edition). The most important change in the ultrasound-
related parameters is the definition of EFFECTIVE RADIATING AREA, 201.3.207. This change will
also affect the value of the EFFECTIVE INTENSITY and its uncertainty.

– 4 – 60601-2-5 © IEC:2009
The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62D/693/CDV 62D/766/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.
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.
– TERMS DEFINED IN CLAUSE 3 OF T
...