SIST EN 62274:2006

SLOVENSKI SIST EN 62274:2006
STANDARD
januar 2006
Medicinska električna oprema – Varnost radioterapevtskih zapisovalno-
preverjalnih sistemov (IEC 62274:2005)
(istoveten EN 62274:2005)
Medical electrical equipment - Safety of radiotherapy record and verify systems IEC
62274:2005)
ICS 11.040.50; 11.040.60 Referenčna številka
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

EUROPEAN STANDARD EN 62274
NORME EUROPÉENNE
EUROPÄISCHE NORM June 2005
ICS 11.040.60
English version
Medical electrical equipment –
Safety of radiotherapy record and verify systems
(IEC 62274:2005)
Appareils électromédicaux –  Medizinische elektrische Geräte –
Sécurité des systèmes d'enregistrement Sicherheit von Aufzeichnungs-
et de vérification de radiothérapie und Verifikationssystemen
(CEI 62274:2005) für die Strahlentherapie
(IEC 62274:2005)
This European Standard was approved by CENELEC on 2005-06-01. 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and 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

© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 62274:2005 E
Foreword
The text of document 62C/381/FDIS, future edition 1 of IEC 62274, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry" des IEC TC 62 "Electrical equipment in
medical practice", was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as EN 62274 on 2005-06-01.
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) 2006-03-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2008-06-01
In this standard, the following print types are used:
- requirements proper: roman type;
- test specifications: italic type;
- notes and explanatory matter: small roman type;
- TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT ARE DEFINED IN CLAUSE 3, OR IN OTHER
STANDARDS: SMALL CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 62274:2005 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 60601-1-6 NOTE Harmonized as EN 60601-1-6:2004 (not modified).
IEC 60601-2-11 NOTE Harmonized as EN 60601-2-11:1997 (not modified).
IEC 60601-2-17 NOTE Harmonized as EN 60601-2-17:2004 (not modified).
IEC 62083 NOTE Harmonized as EN 62083:2001 (not modified).
__________
- 3 - EN 62274:2005
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
IEC 60601-1 1988 Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
A1 1993
+ corr. July 1994
A2 1995
A13 1996
IEC 60601-1-2 2001 Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests

IEC 60601-1-4 1996 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety -
Collateral standard: Programmable
electrical medical systems
A1 1999 A1 1999
IEC 60601-2-29 1999 Part 2-29: Particular requirements for the EN 60601-2-29 1999
safety of radiotherapy simulators

IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
IEC 60950-1 2001 Information technology equipment - Safety EN 60950-1 2001
(mod) Part 1: General requirements + corr. April 2004
+ A11 2004
IEC 61000-2-4 2002 Electromagnetic compatibility (EMC) EN 61000-2-4 2002
Part 2-4: Environment - Compatibility
levels in industrial plants for low-frequency
conducted disturbances
IEC 61217 1996 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
NORME CEI
INTERNATIONALE
IEC
INTERNATIONAL
Première édition
STANDARD
First edition
2005-05
Appareils électromédicaux –
Sécurité des systèmes d'enregistrement
et de vérification de radiothérapie

Medical electrical equipment –
Safety of radiotherapy record
and verify systems
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For price, see current catalogue

62274  IEC:2005 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9
1 Scope and object.11
1.1 Scope.11
1.2 Object .11
1.3 Relationship to other standards .13
2 Normative references .13
3 Terms and definitions .15
4 General requirements for tests .15
4.1 Testing during development .15
4.2 Testing during installation.15
5 ACCOMPANYING DOCUMENTS .15
6 Requirements for safety .17
6.1 RADIATION quantities .17
6.2 Date and time.17
6.3 Coordinate systems and scales .19
6.4 Protection against unauthorized use.19
6.5 Correctness of data transfer .21
6.6 Data acceptance .21
6.7 Deleting and editing data.21
6.8 Backing up data .21
6.9 Archiving data .23
7 TREATMENT machine set-up verification.23
7.1 Prevention of TREATMENT .23
7.2 Override .23
7.3 Transfer of prescribed TREATMENT data.23
7.4 Accompanying information .23
8 TREATMENT recording and reporting .25
9 Accuracy .25
10 Abnormal operation and fault conditions .25
10.1 General hardware diagnostics .25
10.2 Data and code.25
11 Human errors in software design .25
12 Change in software versions.27
13 Human errors in use .27

Annex A (normative) Hardware safety.29

Bibliography.33
Index of defined terms .35

Table 1 – Clauses and subclauses in this standard that require the provision of
information in the ACCOMPANYING DOCUMENTS and the technical description.17

62274  IEC:2005 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
SAFETY OF RADIOTHERAPY RECORD
AND VERIFY SYSTEMS
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 sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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 62274 has been prepared by subcommittee 62C: Equipment for
radiotherapy, nuclear medicine and radiation dosimetry of IEC Technical Committee 62:
Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/381/FDIS 62C/385/RVD
Full information on the voting for the approval of this 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.

62274  IEC:2005 – 7 –
In this standard, the following print types are used:
– requirements proper: roman type;
– test specifications: italic type;
– notes and explanatory matter: small roman type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD THAT ARE DEFINED IN CLAUSE 3, OR IN
OTHER STANDARDS: SMALL CAPITALS.

The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
62274  IEC:2005 – 9 –
INTRODUCTION
A RADIOTHERAPY RECORD AND VERIFY SYSTEM (RVS) is a PEMS (PROGRAMMABLE ELECTRICAL
MEDICAL SYSTEM) or a subsystem that is used to help prevent erroneous set-up of a medical
ELECTRON ACCELERATOR, GAMMA BEAM THERAPY EQUIPMENT, or other RADIOTHERAPY TREATMENT
machine and to record all TREATMENT sessions. This is accomplished through verification of
the set-up and preventing machine operation if the set-up does not match predetermined
settings. Inaccuracies in the data or errors in the record and verify process may represent
SAFETY HAZARDS to PATIENTS. This standard defines requirements to be complied with by
MANUFACTURERS in the design and construction of an RVS in order to provide protection
against the occurrence of such hazards.

62274  IEC:2005 – 11 –
MEDICAL ELECTRICAL EQUIPMENT –
SAFETY OF RADIOTHERAPY RECORD
AND VERIFY SYSTEMS
1 Scope and object
1.1 Scope
This International Standard applies to the design and manufacture and some installation
aspects of a RECORD AND VERIFY SYSTEM (RVS) for use in RADIOTHERAPY in human medical
practice that
a) provides, defines, or displays treatment machine set up data; imports data either through
input by the OPERATOR or directly from other devices,
b) may control the ability of that equipment to operate;
c) records data of all TREATMENT sessions; and
d) is intended to be:
1) for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by
OPERATORS having the required skills and training;
2) maintained in accordance with the recommendations given in the INSTRUCTIONS FOR
USE; and
3) used within the environmental and electrical supply conditions specified in the
technical description.
This standard does not address dynamic beam deliveries.
NOTE This may be addressed in a future version of this standard.
It does, however, address certain specific aspects of the connection of the RVS to a network
or to other radiotherapy equipment, and the communication protocol to be used.
1.2 Object
This standard applies to any RVS and establishes the requirements for features, associated
documentation, and testing of the software. Requirements for SAFETY of hardware are not
included in this standard, as these vary with the nature of the hardware (see 1.3.1 and
Annex A concerning hardware requirements).
An RVS developed by a USER exclusively for the USER’S own use is not within the scope of this
standard, but it is highly recommended that the principles of this standard be applied in its
creation and use. If this technology is provided to another USER under conditions in which the
developers do not directly control its use, and is represented as being suitable for use, then
the developers assume the role of MANUFACTURER and this standard applies.

62274  IEC:2005 – 13 –
1.3 Relationship to other standards
1.3.1 Hardware SAFETY standards
Requirements for SAFETY of hardware, such as for protection against electric shock, fire, and
for ELECTROMAGNETIC COMPATIBILITY, are not included in this document. SAFETY requires that
these subjects be addressed by the MANUFACTURER separately through compliance with an
appropriate standard, depending upon the nature and environment of the hardware used for
the RVS (see Annex A for hardware SAFETY standards).
1.3.2 Software SAFETY standards
All clauses and subclauses of the collateral standard IEC 60601-1-4 (see 4.1) apply.
In applying IEC 60601-1-4, the MANUFACTURER shall consider hazards that could occur due to
use errors associated with the RVS.
NOTE IEC 60601-1-6 describes a process for the risk management of use errors.
1.3.3 IEC 61217
IEC 61217, Radiotherapy equipment – Co-ordinates, movements and scales, applies. The
means of applying IEC 61217 are specified in appropriate subclauses of this standard.
1.3.4 Other standards
Because an RVS is likely to contain PATIENT-related information and other medical data,
standards related to confidentiality of PATIENT information and security of electronic records
may apply. Where there is an apparent conflict between any of these standards and a
requirement of this standard, the MANUFACTURER shall resolve the conflict in a way that best
meets the intent of each standard, and shall explain the implementation in the ACCOMPANYING
DOCUMENTS.
2 Normative references
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for safety
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for safety –
Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment – Part 1-4: General requirements for safety
– Collateral Standard: Programmable electrical medical systems
1)
Amendment 1 (1999)
IEC 60601-2-29, Medical electrical equipment – Part 2-29: Particular requirements for the
safety of radiotherapy simulators
IEC TR 60788, Medical electrical equipment – Glossary of defined terms
___________
1)
A consolidated edition 1.1 exists including IEC 60601-1-4:1996 and its Amendment 1 (1999).

62274  IEC:2005 – 15 –
IEC 60950-1, Information technology equipment – Safety – Part 1: General requirements
IEC 61000 (all parts), Electromagnetic compatibility (EMC)
IEC 61217, Radiotherapy equipment – Co-ordinates, movements and scales
3 Terms and definitions
For the purpose of this document, the terms and definitions given in IEC 60601-1, IEC 60601-1-2,
IEC 60601-1-4, IEC 60601-2-29 and IEC 60788 and the following apply.
3.1
RECORD AND VERIFY SYSTEM
RVS
PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM or subsystem including its associated peripherals,
that is used to compare the set-up of a RADIOTHERAPY TREATMENT machine to predetermined
set-up conditions prior to the start of a proposed RADIOTHERAPY TREATMENT and each
TREATMENT session, and record actual TREATMENT sessions. It also provides a means of
preventing the machine operation if the actual set-up is not the same as the pre-set intended
set-up, within USER defined tolerances.
4 General requirements for tests
4.1 Testing during development
Compliance with IEC 60601-1-4 requires identifi
...