EN 60601-2-7:1998

SLOVENSKI STANDARD
01-september-1998
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Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-
voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998)
Medizinische elektrische Geräte - Teil 2-7: Besondere Festlegungen für die Sicherheit
von Röntgengeneratoren von diagnostischen Röntgenstrahlenerzeugern (IEC 60601-2-
7:1998)
Appareils électromédicaux - Partie 2-7: Règles particulières de sécurité pour générateurs
radiographiques de groupes radiogènes de diagnostic (IEC 60601-2-7:1998)
Ta slovenski standard je istoveten z: EN 60601-2-7:1998
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
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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.
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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 constitutes a
technical revision. The text of this standard is based on the following documents:
FDIS Report on voting
62B/329/FDIS 62B/334/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.
Annexes AA and BB form an integral part of this standard.
Annex CC is for information only.
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 type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR IN IEC 60788: SMALL CAPITALS.
A bilingual version of this standard may be issued at a later date.

60601-2-7 © IEC:1998 (E) – 5 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-7: Particular requirements for the safety of
high-voltage generators of diagnostic X-ray generators
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
Replacement:
This Particular Standard 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.
Where appropriate, requirements for X-RAY GENERATORS are given but only where these
concern the functioning of the associated HIGH-VOLTAGE GENERATOR.
This standard excludes
– CAPACITOR DISCHARGE HIGH-VOLTAGE GENERATORS (these are covered by IEC 60601-2-15),
– HIGH-VOLTAGE GENERATORS for mammography,
– HIGH-VOLTAGE GENERATORS for RECONSTRUCTIVE TOMOGRAPHY.
1.2 Object
Replacement:
The object of this standard is 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
safety of HIGH-VOLTAGE GENERATORS is not sensitive to small differences in levels of performance. The combinations
of LOADING FACTORS specified for the tests are, therefore, limited in number but chosen from experience as being
appropriate in most cases. It is considered important to standardize the choice of combinations of LOADING FACTORS
so that comparison can be made between tests performed in different places on different occasions. However,
combinations other than those specified could be of equal technical validity.
NOTE 3 – The safety philosophy on whi
...