IEC 60601-2-17:2013

Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment

IEC 60601-2-17:2013 applies to the basic safety and essential performance of automatically-controlled Brachytherapy Afterloading Medical Equipment. This standard does not specify requirements for sealed radioactive sources. This third edition cancels and replaces the second edition, published in 2004. Consideration has been given to new IEC standards, amendments to existing IEC standards, developments in technology and clinical usage, and various hazards encountered and envisaged since the preparation of the first and second editions. This edition constitutes a technical revision which brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.

Appareils électromédicaux - Partie 2-17: Exigences particulières pour la sécurité de base et les performances essentielles des appareils projecteurs de sources radioactives à chargement différé automatique utilisés en brachythérapie

L'IEC 60601-2-17:2013 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux de projection de sources radioactives a chargement différé automatique utilisés en Brachythérapie. La présente norme ne précise pas les exigences relatives aux sources radioactives scellées. Cette troisième édition annule et remplace la deuxième édition publiée en 2004. Ont été pris en considération les nouvelles normes CEI, les amendements aux normes CEI existantes, les développements des technologies et des utilisations médicales, ainsi que les différents dangers qui ont été rencontrés et envisagés depuis la préparation de la première édition et de la deuxième édition. Cette édition constitue une révision technique qui aligne cette norme avec la CEI 60601-1:2005+A1:2012 et ses normes collatérales.

General Information

• Status: Published
• Publication Date: 26-Nov-2013
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 1 - TC 62/SC 62C/WG 1
• Current Stage: PPUB - Publication issued
• Start Date: 31-Dec-2013
• Completion Date: 27-Nov-2013

Relations

• Revises: IEC 60601-2-17:2004 - Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-17 ®
Edition 3.0 2013-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-17: Particular requirements for the basic safety and essential performance
of automatically-controlled brachytherapy afterloading equipment

Appareils électromédicaux –
Partie 2-17: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils projecteurs de sources radioactives à chargement
différé automatique utilisés en brachythérapie

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IEC 60601-2-17 ®
Edition 3.0 2013-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-17: Particular requirements for the basic safety and essential

performance of automatically-controlled brachytherapy afterloading equipment

Appareils électromédicaux –
Partie 2-17: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils projecteurs de sources radioactives à

chargement différé automatique utilisés en brachythérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.040.60 ISBN 978-2-8322-1214-1

– 2 – 60601-2-17  IEC:2013
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 12
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 . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 37
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 37
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 40
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 40
201.15 Construction of ME EQUIPMENT . 40
201.16 ME SYSTEMS . 40
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 40
Annex A (informative) General guidance and rationale . 41
Bibliography . 42
Index of defined terms used in this particular standard . 43

Table 201.101 – Colours of lights and their meanings . 14

60601-2-17  IEC:2013 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy
afterloading equipment
FOREWORD
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International standard IEC 60601-2-17 has been prepared by IEC subcommittee 62C:
Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical
committee 62: Electrical equipment in medical practice.
This third edition cancels and replaces the second edition, published in 2004. Consideration
has been given to new IEC standards, amendments to existing IEC standards, developments
in technology and clinical usage, and various hazards encountered and envisaged since the
preparation of the first and second editions. This edition constitutes a technical revision which
brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.

– 4 – 60601-2-17  IEC:2013
The text of this particular standard is based on the following documents:
FDIS Report on voting
62C/575/FDIS 62C/579/RVD
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.
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– 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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
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– “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and
201.7.2.1 are all subclauses of Clause 201.7).
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– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with
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