IEC 60601-2-29:2008

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators

IEC 60601-2-29:2008 establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

Appareils électromédicaux - Partie 2-29: Exigences particulières pour la sécurité de base et performances essentielles des simulateurs de radiothérapie

La CEI 60601-2-29:2008 décrit les exigences auxquelles les fabricants doivent se conformer lors de la conception et de la construction des simulateurs de radiothérapie; elle ne vise pas à définir des exigences de performances optimales. Son objet est d'identifier les caractéristiques de conception reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels appareils électromédicaux. Elle fixe des limites de détérioration des performances des appareils électromédicaux qui seraient la conséquence d'une condition de défaut, telle que la défaillance d'un composant, pour lesquelles un verrouillage doit entrer en action pour empêcher l'appareil électromédical de continuer à fonctionner. Cette troisième édition annule et remplace la deuxième édition parue en 1999, dont elle constitue une révision technique, qui représente un alignement de cette norme avec la troisième édition de la CEI 60601-1 et ses normes collatérales.

General Information

• Status: Published
• Publication Date: 10-Jun-2008
• 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-Aug-2008
• Completion Date: 11-Jun-2008

Relations

• Revises: IEC 60601-2-29:1999 - Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-29
Edition 3.0 2008-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-29: Particular requirements for the basic safety and essential performance
of radiotherapy simulators
Appareils électromédicaux –
Partie 2-29: Exigences particulières pour la sécurité de base et les performances
essentielles des simulateurs de radiothérapie

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IEC 60601-2-29
Edition 3.0 2008-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-29: Particular requirements for the basic safety and essential performance
of radiotherapy simulators
Appareils électromédicaux –
Partie 2-29: Exigences particulières pour la sécurité de base et les performances
essentielles des simulateurs de radiothérapie

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
T
CODE PRIX
ICS 11.040.60 ISBN 2-8318-9854-4

– 2 – 60601-2-29 © IEC:2008
CONTENTS
FOREWORD.3
INTRODUCTION.5

201.1 Scope, object and related standards .6
201.2 Normative references.7
201.3 Terms and definitions.8
201.4 General requirements.8
201.5 General requirements for testing of ME EQUIPMENT.8
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .8
201.7 ME EQUIPMENT identification, marking and documents.9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.11
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS .11
201.10 Protection against unwanted and excessive radiation HAZARDS.18
201.11 Protection against excessive temperatures and other HAZARDS.18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.19
201.13 HAZARDOUS SITUATIONS and fault conditions.19
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .19
201.15 Construction of ME EQUIPMENT .19
201.16 ME SYSTEMS .19
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .19
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.20
Annex AA (informative) Particular guidance and rationale.21
Bibliography.22
Index of defined terms used in this particular standard.23

Figure 101 – Equipment movements and scales – Rotary GANTRY with identification of
axes 1 to 8, directions 9 to 13, and dimensions 14 and 15 (see accompanying table) .14
Figure 102 – Equipment movements and scales – ISOCENTRIC RADIOTHERAPY SIMULATOR
or TELERADIOTHERAPY ME EQUIPMENT, with identification of axes 1; 4 to 6; 19, of
directions 9 to 12; 16 to 18 and of dimensions 14; 15 (see accompanying table).
Figure 103 – Equipment movements and scales – View from RADIATION SOURCE of
TELERADIOTHERAPY RADIATION FIELD or RADIOTHERAPY SIMULATOR DELINEATED RADIATION
FIELD (see accompanying table) .16

Table 201.101 – Description of equipment movements .17
Table 201.C.101 – ACCOMPANYING DOCUMENTS, General .20
Table 201.C.102 – ACCOMPANYING DOCUMENTS, Instructions for use .20
Table 201.C.103 – ACCOMPANYING DOCUMENTS, technical description.20

60601-2-29 © IEC:2008 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators

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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indispensable for the correct application of this publication.
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 60601-2-29 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 1999. This edition
constitutes a technical revision, which brings this standard in line with the third edition of
IEC 60601-1 and its collateral standards.
The text of this particular standard is based on the following documents:
CDV Report on voting
62C/423/CDV 62C/434/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.

– 4 – 60601-2-29 © IEC:2008
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
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of th
...