IEC 60601-2-45:2001
(Main)Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
The object of this standard is 1. to formulate appropriate design and manufacturing requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices, reflecting the particular characteristics and circumstances of use of such equipment; 2. to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements. It is the bilingual version of the english version published in 2001.
Appareils électromédicaux - Partie 2-45: Règles particulières de sécurité pour les appareils de radiographie mammaire et les appareils mammographiques stéréotaxiques
La présente norme a pour objet: 1. de donner les exigences de conception et de fabrication appropriées pour la sécurité des équipements de mammographie à rayonnement x et des appareils de mammographie stéréotaxique, reflétant les caractéristiques et les circonstances particulières d'utilisation de ce type de matériel; 2. d'établir des exigences particulières pour assurer la sécurité et de spécifier des méthodes pour démontrer la conformité avec ces exigences. C'est la version bilingue de la version anglaise publiée en 2001.
General Information
Relations
Buy Standard
Standards Content (Sample)
INTERNATIONAL IEC
STANDARD
60601-2-45
Second edition
2001-05
Medical electrical equipment –
Part 2-45:
Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices
Appareils électromédicaux –
Partie 2-45:
Règles particulières de sécurité pour les appareils
de radiographie mammaire et les appareils
mammographiques stéréotaxiques
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
Further information on IEC publications
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology. Information relating to
this publication, including its validity, is available in the IEC Catalogue of
publications (see below) in addition to new editions, amendments and corrigenda.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is also available from the following:
• IEC Web Site (www.iec.ch)
• Catalogue of IEC publications
The on-line catalogue on the IEC web site (www.iec.ch/catlg-e.htm) enables
you to search by a variety of criteria including text searches, technical
committees and date of publication. On-line information is also available on
recently issued publications, withdrawn and replaced publications, as well as
corrigenda.
• IEC Just Published
This summary of recently issued publications (www.iec.ch/JP.htm) is also
available by email. Please contact the Customer Service Centre (see below) for
further information.
• Customer Service Centre
If you have any questions regarding this publication or need further assistance,
please contact the Customer Service Centre:
Email: custserv@iec.ch
Tel: +41 22 919 02 11
Fax: +41 22 919 03 00
INTERNATIONAL IEC
STANDARD
60601-2-45
Second edition
2001-05
Medical electrical equipment –
Part 2-45:
Particular requirements for the safety of
mammographic X-ray equipment and
mammographic stereotactic devices
Appareils électromédicaux –
Partie 2-45:
Règles particulières de sécurité pour les appareils
de radiographie mammaire et les appareils
mammographiques stéréotaxiques
IEC 2001 Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
S
International Electrotechnical Commission
For price, see current catalogue
– 2 – 60601-2-45 IEC:2001(E)
CONTENTS
FOREWORD 4
..........................................................................................................................
SECTION 1: GENERAL
1 Scope and object 6
...............................................................................................................
1.1 Scope 6
.......................................................................................................................
1.2 Object 6
.......................................................................................................................
1.3 Particular Standards 7
.................................................................................................
2 Terminology and definitions 8
................................................................................................
3 General requirements 10
......................................................................................................
5 Classification 10
...................................................................................................................
6 Identification, marking and documents 10
..............................................................................
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts 10
.........................................
6.7 Indicator lights and push-buttons 11
.............................................................................
6.8 ACCOMPANYING DOCUMENTS 12
.....................................................................................
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions 14
...............................................................................................
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy 15
..............................................................................
NCLOSURES PROTECTIVE COVERS
16 E and 16
..........................................................................
LEAKAGE CURRENTS PATIENT AUXILIARY CURRENTS
19 Continuous and 16
.................................
19.3 Allowable values 16
................................................................................................
20 Dielectric strength 17
.......................................................................................................
20.3 Values of test voltages 17
.......................................................................................
20.4 Tests 17
.................................................................................................................
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength 18
....................................................................................................
22 Moving parts 20
................................................................................................................
24 Stability in NORMAL USE 23
................................................................................................
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
29 X-RADIATION 24
.................................................................................................................
29.1 X-RADIATION generated by mammographic X-RAY EQUIPMENT 24
..............................
36 Electromagnetic compatibility 28
.......................................................................................
60601-2-45 IEC:2001(E) – 3 –
SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures 28
..............................................................................................
SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data 29
..........................................................................................
50.1 General 29
.........................................................................................................
50.101 Indication of electric and RADIATION output 29
......................................................
50.102 Reproducibility, linearity and constancy 30
..........................................................
LOADING FACTORS
50.103 Accuracy of 32
........................................................................
50.104 Test conditions 33
..............................................................................................
AIR KERMA
50.105 Conditions for measuring 34
...............................................................
51 Protection against hazardous output 34
............................................................................
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly 35
.............................................................................
56.7 Batteries 35
............................................................................................................
57 MAINS PARTS, components and layout 35
...........................................................................
57.10 CREEPAGE DISTANCES and AIR CLEARANCES 35
........................................................
Annex AA (normative) Terminology – Index of defined terms 37
................................................
Annex BB (informative) Rationale for allowing full IRRADIATION of mammograms 40
...................
Annex CC (normative) Values of the series R´10 and R´20, ISO 497 41
....................................
Bibliography 42
.........................................................................................................................
Figure 101 – Example of a TEST DEVICE for MAMMOGRAPHIC STEREOTACTIC DEVICES 36
................
Table 101 – Tests for verifying reproducibility and linearity 34
....................................................
– 4 – 60601-2-45 IEC:2001(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
__________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-45: Particular requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-45 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 1998 and constitutes a
technical revision.
The text of this Particular Standard is based on the following documents:
FDIS Report of voting
62B/427/FDIS 62B/438/RVD
Full information on the voting for the approval of this standard can be found in the report of
voting indicated in the above table.
Annexes AA and CC form an integral part of this standard.
Annex BB is for information only.
60601-2-45 IEC:2001(E) – 5 –
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements and exceptions: smaller roman type;
– test specifications and headings of subclauses: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD, IN THIS STANDARD, IN IEC 60788 OR IN
OTHER IEC STANDARDS REFERENCED IN ANNEX AA: SMALL CAPITALS.
NOTE Attention is drawn to the existence of legislation in some countries concerning RADIATION safety which may
not align with the provisions of this standard.
The committee has decided that the contents of this publication will remain unchanged until
2004-06. At this date, the publication will be
reconfirmed;
•
withdrawn;
•
replaced by a revised edition, or
•
amended.
•
A bilingual version of this publication may be issued at a later date.
– 6 – 60601-2-45 IEC:2001(E)
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-45: Particular requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices
SECTION 1: GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard contains requirements for the safety of X-RAY EQUIPMENT designed for
mammography and MAMMOGRAPHIC STEREOTACTIC DEVICES. The safety requirements for the
RAY GENERATOR
X- and its sub-assemblies form an integral part of this standard.
1.2 Object
Replacement:
The object of this standard is
1 to formulate appropriate design and manufacturing requirements for the safety of
mammographic X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, reflecting the
particular characteristics and circumstances of use of such equipment;
2 to establish particular requirements to ensure safety and to specify methods for
demonstrating compliance with those requirements.
NOTE 1 Requirements for reproducibility, linearity, constancy and accuracy are given because of their relationship
to the quality and quantity of the IONIZING RADIATION produced and are confined to those considered necessary for
safety.
NOTE 2 Both the levels for compliance and the tests prescribed to determine compliance reflect the fact that the
saf
...
IEC 60601-2-45
Edition 2.0 2001-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-45: Particular requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices
Appareils électromédicaux –
Partie 2-45: Règles particulières de sécurité pour les appareils de radiographie
mammaire et les appareils mammographiques stéréotaxiques
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or
IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: inmail@iec.ch
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: csc@iec.ch
Tel.: +41 22 919 02 11
Fax: +41 22 919 03 00
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: csc@iec.ch
Tél.: +41 22 919 02 11
Fax: +41 22 919 03 00
IEC 60601-2-45
Edition 2.0 2001-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-45: Particular requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices
Appareils électromédicaux –
Partie 2-45: Règles particulières de sécurité pour les appareils de radiographie
mammaire et les appareils mammographiques stéréotaxiques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.50 ISBN 2-8318-8519-1
– 2 – 60601-2-45 © CEI:2001
SOMMAIRE
AVANT-PROPOS .6
SECTION 1: GÉNÉRALITÉS
1 Domaine d’application et objet .10
1.1 Domaine d'application.10
1.2 Objet.10
1.3 Normes Particulières .12
2 Terminologie et définitions .14
2.101 Définitions supplémentaires .16
3 Exigences générales.18
5 Classification.18
6 Identification, marquage et documentation .18
6.1 Marquage sur l’extérieur de l’APPAREIL ou des parties d’APPAREIL .18
6.7 Voyants lumineux et boutons poussoirs.22
6.8 Documents d’accompagnement .22
SECTION 2: CONDITIONS D’ENVIRONNEMENT
10 Conditions d'environnement .28
SECTION 3: PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES
15 Limitation des tensions et/ou de l’énergie.30
16 ENVELOPPES et CAPOTS DE PROTECTION .30
19 COURANTS DE FUITE PERMANENTS et COURANTS AUXILIAIRES PATIENT .30
19.3 Valeurs admissibles.30
20 Tension de tenue .32
20.3 Valeurs des tensions d'essai.32
20.4 Essais.34
SECTION 4: PROTECTION CONTRE LES RISQUES MÉCANIQUES
21 Résistance mécanique.36
21.101 Application d’une force de compression maximale .36
22 Parties en mouvement .40
22.101 Mouvement de l’ensemble TUBE RADIOGENE – récepteur d’image .40
22.102 Dispositif de compression .40
22.103 APPAREILS DE MAMMOGRAPHIE STEREOTAXIQUE .44
24 Stabilité en UTILISATION NORMALE.46
SECTION 5: PROTECTION CONTRE LES RISQUES DUS
AUX RAYONNEMENTS NON DÉSIRÉS OU EXCESSIFS
29 RAYONNEMENTS X.48
29.1 RAYONNEMENTS X générés par les EQUIPEMENTS de mammographie A
RAYONNEMENT X .48
60601-2-45 © IEC:2001 – 3 –
CONTENTS
FOREWORD.7
SECTION 1: GENERAL
1 Scope and object .11
1.1 Scope.11
1.2 Object.11
1.3 Particular standards.13
2 Terminology and definitions .15
2.101 Additional definitions.17
3 General requirements .19
5 Classification.19
6 Identification, marking and documents .19
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts .19
6.7 Indicator lights and push-buttons .23
6.8 ACCOMPANYING DOCUMENTS .23
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions .29
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy.31
16 ENCLOSURES and PROTECTIVE COVERS .31
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.31
19.3 Allowable values.31
20 Dielectric strength.33
20.3 Values of test voltages.33
20.4 Tests.35
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.37
21.101 Application of maximum compression force .37
22 Moving parts.41
22.101 Motion of X-RAY TUBE – image receptor assembly.41
22.102 COMPRESSION DEVICE .41
22.103 MAMMOGRAPHIC STEREOTACTIC DEVICE .45
24 Stability in NORMAL USE.47
SECTION 5: PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
29 X-RADIATION.49
29.1 X-RADIATION generated by mammographic X-RAY EQUIPMENT .49
– 4 – 60601-2-45 © CEI:2001
29.207 BARRIERES DE PROTECTION CONTRE LE FAISCEAU .54
29.208 Protection contre les RAYONNEMENTS PARASITES.56
36 Compatibilité électromagnétique .56
SECTION 6: PROTECTION CONTRE LES RISQUES D’IGNITION
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES
SECTION 7: PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET LES AUTRES RISQUES
42 Températures excessives.56
SECTION 8: PRECISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE
PRÉSENTANT DES RISQUES
50 Précision des caractéristiques de fonctionnement .58
50.1 Généralités.58
50.101 Indication des caractéristiques de sortie électriques et de RAYONNEMENT .58
50.102 Reproductibilité, linéarité et constance.
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.