EN 60601-2-29:2008

SLOVENSKI STANDARD
01-februar-2009
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Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and
essential performance of radiotherapy simulators (IEC 60601-2-29:2008)
Medizinische elektrische Geräte - Teil 2-29: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Strahlentherapiesimulatoren
(IEC 60601-2-29:2008)
Appareils électromédicaux - Partie 2-29: Exigences particulières pour la sécurité de base
et performances essentielles des simulateurs de radiothérapie (CEI 60601-2-29:2008)
Ta slovenski standard je istoveten z: EN 60601-2-29:2008
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-29
NORME EUROPÉENNE
November 2008
EUROPÄISCHE NORM
ICS 11.040.60 Supersedes EN 60601-2-29:1999

English version
Medical electrical equipment -
Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators
(IEC 60601-2-29:2008)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-29: Exigences particulières Teil 2-29: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des simulateurs de radiothérapie von Strahlentherapiesimulatoren
(CEI 60601-2-29:2008) (IEC 60601-2-29:2008)

This European Standard was approved by CENELEC on 2008-11-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-29:2008 E
Foreword
The text of document 62C/423/CDV, future edition 3 of IEC 60601-2-29, prepared by SC 62C, Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical
practice, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved
by CENELEC as EN 60601-2-29 on 2008-11-01.
This European Standard supersedes EN 60601-2-29:1999.
EN 60601-1:2006 and its collateral standards.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2009-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2011-11-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS 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 the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
Annexes ZA and ZZ have been added by CENELEC.
__________
- 3 - EN 60601-2-29:2008
Endorsement notice
The text of the International Standard IEC 60601-2-29:2008 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60601-1-3 NOTE  Harmonized as EN 60601-1-3:2008 (not modified).
IEC 60601-1-8 NOTE  Harmonized as EN 60601-1-8:2007 (not modified).
IEC 60601-2-1 NOTE  Harmonized as EN 60601-2-1:1998 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

Addition to Annex ZA of EN 60601-1:2006:
Publication Year Title EN/HD Year

IEC/TR 60788 2004 Medical electrical equipment - - -
Glossary of defined terms
1) 2)
IEC 61217 - Radiotherapy equipment - EN 61217 1996
Coordinates, movements and scales

1)
Undated reference.
2)
Valid edition at date of issue.

- 5 - EN 60601-2-29:2008
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives

This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
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,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sens
...