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

Status
Published
Publication Date
28-May-2001
Current Stage
DELPUB - Deleted Publication
Completion Date
10-Feb-2011
Ref Project

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IEC 60601-2-45:2001 - Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices Released:5/29/2001 Isbn:283185797X
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IEC 60601-2-45:2001 - Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices Released:5/29/2001 Isbn:2831885191
English and French language
87 pages
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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.
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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
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publications (see below) in addition to new editions, amendments and corrigenda.
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please contact the Customer Service Centre:
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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

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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.
...

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