IEC 60601-2-7:1998

Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

Applies to high-voltage generators of medical diagnostic X-ray generators and to their subassemblies including the following : - high-voltage generators that are integrated with an X-ray tube assembly; - high-voltage generators of radiotherapy treatment simulators. The object of this standard is to establish particular requirements to ensure safety and to specify methods for demonstrating compliance with those requirements.

General Information

• Status: Replaced
• Publication Date: 31-Jan-1998
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Current Stage: WPUB - Publication withdrawn
• Completion Date: 12-Oct-2012

Relations

• Replaced By: IEC 60601-2-63:2012 - Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
• Effective Date: 05-Sep-2023
• Replaced By: IEC 60601-2-65:2012 - Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL
IEC
STANDARD
60601-2-7
Second edition
1998-02
Medical electrical equipment –
Part 2-7:
Particular requirements for the safety of
high-voltage generators of diagnostic
X-ray generators
Appareils électromédicaux –
Partie 2-7:
Règles particulières de sécurité pour générateurs
radiographiques de groupes radiogènes de diagnostic

Numéro de référence
Reference number
CEI/IEC 60601-2-7:1998 (E)
Numéros des publications Numbering

Depuis le 1er janvier 1997, les publications de la CEI As from 1 January 1997 all IEC publications are

sont numérotées à partir de 60000. issued with a designation in the 60000 series.

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indiquent respectivement la publication de base, la the base publication, the base publication
publication de base incorporant l’amendement 1, et la incorporating amendment 1 and the base publication
publication de base incorporant les amendements 1 incorporating amendments 1 and 2.

et 2.
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Terminologie, symboles graphiques Terminology, graphical and letter
et littéraux symbols
En ce qui concerne la terminologie générale, le lecteur For general terminology, readers are referred to
se reportera à la CEI 60050: Vocabulaire Electro- IEC 60050: International Electrotechnical Vocabulary
technique International (VEI). (IEV).
Pour les symboles graphiques, les symboles littéraux For graphical symbols, and letter symbols and signs
et les signes d'usage général approuvés par la CEI, le approved by the IEC for general use, readers are
referred to publications IEC 60027: Letter symbols to
lecteur consultera la CEI 60027: Symboles littéraux à
utiliser en électrotechnique, la CEI 60417: Symboles be used in electrical technology, IEC 60417: Graphical
graphiques utilisables sur le matériel. Index, relevé et symbols for use on equipment. Index, survey and
compilation des feuilles individuelles, et la CEI 60617: compilation of the single sheets and IEC 60617:
Symboles graphiques pour schémas. Graphical symbols for diagrams.

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* Voir adresse «site web» sur la page de titre. * See web site address on title page.

INTERNATIONAL
IEC
STANDARD
60601-2-7
Second edition
1998-02
Medical electrical equipment –
Part 2-7:
Particular requirements for the safety of
high-voltage generators of diagnostic
X-ray generators
Appareils électromédicaux –
Partie 2-7:
Règles particulières de sécurité pour générateurs
radiographiques de groupes radiogènes de diagnostic

 IEC 1998 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun any form or by any means, electronic or mechanical,
procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE X
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

– 2 – 60601-2-7 © IEC:1998 (E)

CONTENTS
Page
FOREWORD .4

SECTION 1: GENERAL
Clause
1 Scope and object . 5

1.1 Scope . 5
1.2 Object. 5
1.3 Particular Standards . 6
2 Terminology and definitions. 7
2.101 Qualifying conditions for defined terms . 8
3 General requirements . 9
5 Classification . 9
6 Identification, marking and documents. 9
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts . 9
6.7 Indicator lights and push-buttons. 10
6.8 ACCOMPANYING DOCUMENTS . 11
SECTION 2: ENVIRONMENTAL CONDITIONS
10 Environmental conditions . 13
SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 Limitation of voltage and/or energy. 15
16 ENCLOSURES and PROTECTIVE COVERS . 15
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 15
19.3 Allowable values. 15
20 Dielectric strength. 16

20.3 Values of test voltages. 16
20.4 Tests. 17
SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
29 X-RADIATION. 18
29.1 X-RADIATION generated by diagnostic X-RAY GENERATORS containing
HIGH-VOLTAGE GENERATORS . 18
36 Electromagnetic compatibility. 22

60601-2-7 © IEC:1998 (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. 22

SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION

AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data. 23
50.1 General. 23
50.101 Indication of electric and RADIATION output. 23
50.102 Reproducibility, linearity and constancy . 24
50.103 Accuracy of LOADING FACTORS. 28
50.104 Test conditions. 28
50.105 Conditions for measuring AIR KERMA . 30
51 Protection against hazardous output . 32
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION 10: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly. 32
56.7 Batteries . 32
57 MAINS PARTS, components and layout. 33
57.10 CREEPAGE DISTANCES and AIR CLEARANCES . 33
Tables
101 Reference values for the APPARENT RESISTANCE OF SUPPLY MAINS . 13
102 Duration of dielectric strength test . 17
103 LOADINGS for testing AUTOMATIC EXPOSURE CONTROLS . 27
104 ATTENUATION for the measurement of AIR KERMA . 31
105 Tests for verifying reproducibility and linearity. 32
CC.1 Recommended LOADING FACTORS for the testing of accuracy . 41

CC.2 Test settings for measurement of AIR KERMA . 42
Figures
AIR KERMA
101 Recommended arrangement for measuring . 34
102 Recommended arrangement for film density testing AUTOMATIC CONTROL SYSTEMS
provided with a TRANSMISSION CHAMBER. 35
Annexes
AA Terminology – Index of defined terms . 36
BB Values of the series R'10 and R'20, ISO 497. 39
CC Choosing LOADING FACTORS for tests . 40

– 4 – 60601-2-7 © IEC:1998 (E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

_________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-7: Particular requirements for the safety of

high-voltage generators of diagnostic X-ray generators

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 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 60601-2-7 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 1987, and constitu
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