EN 60601-2-8:1997

SLOVENSKI STANDARD
01-oktober-1998
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Medical electrical equipment - Part 2: Particular requirements for the safety of
therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:1987)
Medizinische elektrische Geräte - Teil 2: Besondere Festlegungen für die Sicherheit von
Therapie-Röntgeneinrichtungen im Betriebsbereich von 10 kV bis 1 MV (IEC 60601-2-
8:1987)
Appareils électromédicaux - Partie 2: Règles particulières de sécurité pour les
équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV
(CEI 60601-2-8:1987)
Ta slovenski standard je istoveten z: EN 60601-2-8:1997
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

NORME CEI
INTERNATIONALE IEC
601-2-8
INTERNATIONAL
Première
édition
STAN DARD
First edition
Appareils électromédicaux
Deuxième partie:
Règles particulières de sécurité pour
groupes radiogènes de radiothérapie
Medical electrical equipment
Part 2:
Particular requirements for the safety of
therapeutic X-ray generators
© CEI 1987 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
utilisée sous quelque forme que ce soit
et par aucun procédé, in any form or by any means, electronic or mechanical,
électronique ou mécanique, y compris la
photocopie et les including photocopying and microfilm, without permission
microfilms, sans l'accord écrit de l'éditeur. in writing from the publisher
Bureau central de la Commission Electrotechnique Internationale 3, rue de Varembé Genève Suisse
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International Electrotechnical Commission PRICE CODE
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601-2-8 © I E C 1987
CONTENTS
Page
FOREWORD 9
PREFACE 9
SECTION ONE - GENERAL
Clause
1. Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
1.3.101 Relation to the General Standard
1.3.102 Superseded I E C Standard
1.4 Environmental conditions
2. Terminology and definitions 13
3. General requirements
3.101 Conventional meaning of electrical quantities
4. General requirements for tests
4.1 Type tests and routine tests
4.7 Supply and test voltages, type of current, nature of supply, frequency 15
4.10 Moisture pre-conditioning treatment
5. Classification
6. Identification, marking and documents
6.1 Marking on the outside of equipment and equipment parts
6.2 Marking on the inside of equipment and equipment pa rts 19
6.7 Indicator lights and push-buttons
6.8 ACCOMPANYING DOCUMENTS
Power input 25
7.
SECTION TWO - SAFETY REQUIREMENTS
8. Basic safety categories 25
9. Removable protective means 25
10. Special environmental conditions
Special measures with respect to safety 25
11.
12. SINGLE FAULT CONDITION 25
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13. General
14. Requirements related to classification
15. Limitation of voltage and/or current
16. Enclosures and PROTECTIVE COVERS
17. Insulation and PROTECTIVE IMPEDANCES 27
18. Earthing and potential equalization
19. Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS 27
19.3 Allowable values 29
20. Dielectric strength 29
20.3 Values of test voltages 29
20.4 31
Tests
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21. Mechanical strength
22. Moving parts
23. Surfaces, corners and edges
24. Stability and transportability

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601-2-8 © I E C 1987
Expelled parts
25.
Vibration and noise 33
26.
27. Pneumatic and hydraulic power
28. Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29. X-radiation
X-RAY GENERATORS 33
29.1 X-RADIATION generated by therapeutic
29.101 NORMAL CONDITION
29.102 SINGLE FAULT CONDITION
30. Alpha, beta, gamma, neutron radiation and other particle radiation
31. Microwave radiation
32. Light radiation (including visual radiation and lasers)
33. Infra-red radiation
Ultra-violet radiation 34.
35. Acoustical energy (including ultrasonics)
36. Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF EXPLOSIONS IN MEDICALLY USED ROOMS
37. General
ACCOMPANYING DOCUMENTS of ANAESTHETIC-PROOF EQUIPMENT 38. Classification, marking and
51 39. Common requirements for "AP" and "APG" equipment
Requirements and tests for ANAESTHETIC-PROOF EQUIPMENT, equipment parts or components (AP)
40.
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES, FIRE AND OTHER HAZARDS, SUCH AS HUMAN ERRORS
42. Excessive temperatures
42.4 Compliance tests
43. Fire prevention
44. Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
45. Pressure vessels and parts subject to pressure
46. Human errors
47. Electrostatic charges
Materials in APPLIED PARTS in contact with the body of the PATIENT 48.
49. Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST INCORRECT OUTPUT
50. Accuracy of operating data
53 50.1 Indication of radiation output
50.2 Agreement between indicated values and effective values
50.101 to 50.104 - REQUIREMENTS ON TESTS 59
50.101 General test conditions
50.102 Settings for measurements
50.103 Number of measurements
50.104 Measurements and evaluation
51. Protection against incorrect output
SECTION NINE - FAULT CONDITIONS CAUSING OVERHEATING AND/OR MECHANICAL DAMAGE; ENVIRONMENTAL TESTS
52. Fault conditions causing overheating and/or mechanical damage
53. Environmental tests
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601-2-8 © I EC 1987
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54. General
55. Enclosures and covers
56. Components and general assembly 67
57. MAINS PARTS, components and layout
58. PROTECTIVE EARTH TERMINALS
59. Construction and layout 67
59.4 Oil containers
TABLE 101 - Permissible LEAKAGE RADIATION
TABLE 102 — LEAKAGE RADIATION from X-RAY SOURCE ASSEMBLIES with BEAM LIMITING DEVICES or
Permissible
therapeutic BEAM APPLICATORS
TABLE 103 — Diagram of measurements
APPENDIX AA — Terminology — Indices of terms

601-2-8 © I E C 1987
INTERNATIONAL ELECTROTECHNICAL COMMISSION
MEDICAL ELECTRICAL EQUIPMENT
Part 2: Particular requirements for the safety of therapeutic
X-ray generators
FOREWORD
I) The formal decisions or agreements of the I E C on technical matters, prepared by Technical Committees on which all
the National Committees having a special interest therein are represented, express, as nearly as possible, an international
consensus of opinion on the subjects dealt with.
2) They have the form of recommendations for international use and they are accepted by the National Committees in that
sense.
In order to promote international unification, the I E C expresses the wish that all National Committees should adopt
3)
the text of the I E C recommendation for their national rules in so far as national conditions will permit. Any divergence
between the I E C recommendation and the corresponding national rules should, as far as possible, be clearly indicated
in the latter.
The I E C has not laid down any procedure concerning marking as an indication of approval and has no responsibility
4)
when an item of equipment is declared to comply with one of its recommendations.
PREFACE
This Particular Standard has been prepared by Sub-Committee 62B: X-ray Equipment Operating up to 400 kV and
Accessories, of I E C Technical Committee No. 62: Electrical Equipment in Medical Practice.
The text of this standard is based upon the following documents:
Report on Voting
Six Months' Rule
62B(CO)64
62B(CO)49
Further information can be found in the Report on Voting indicated in the table above.
This Particular Standard amends and supplements I E C Publication 601-1 (first edition 1977): Safety of Medical Electrical
Equipment. Part 1: General Requirements, hereinafter referred to as the General Standard. The requirements of this
Particular Standard take priority over those of the General Standard. The title of the General Standard will be changed in
the next editions to read: Medical Electrical Equipment, Part 1: General Requirements for Safety. This change is anticipated
in the title of this Particular Standard.
The numbering of sections, clauses and sub-clauses of this Particular Standard corresponds with that of the General
Standard.
ures which are additional to those of the General Standard are numbered starting from 101; additional
Sub-clauses or fi g
aa), bb), etc.
appendices are lettered AA, BB, etc. and additional items
In this standard, the following print types are used:
requirements, compliance with which can be tested and definitions: in roman type;
explanations, advice, introductions, general statements, exceptions and references: in smaller type;
test specifications: in italic type;
788 OR IN THIS
OF THE GENERAL STANDARD, IN I E C PUBLICATION
TERMS DEFINED IN CLAUSE 2
PARTICULAR STANDARD: SMALL CAPITALS.

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601-2-8 © I E C 1987
MEDICAL ELECTRICAL EQUIPMENT
Part 2: Particular requirements for the safety of therapeutic
X-ray generators
SECTION ONE — GENERAL
1. Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard applies to therapeutic X -RAY GENERATORS that operate with
NOMINAL X-RAY TUBE VOLTAGES from 10 kV to 400 kV inclusive when connected to alternating
current SUPPLY MAINS.
1.2 Object
Replacement:
The object of this Particular Standard is to establish the particular requirements for safety
including the requirements for accuracy and reproducibility of performance to the extent that
these are related to RADIATION QUALITY and the quantity of IONIZING RADIATION produced and
thus must be considered as aspects of safety.
An object of this Particular Standard is to present the general functional requirements of
the demand for safety, rather than any particular technological means of implementation.
1.3 Particular Standards
Additional sub-clauses:
1.3.101 Relation to the General Standard
This Particular Standard refers to, and is to be read in conjunction with I E C Publication
601-1 (1977): Safety of Medical Electrical Equipment, Part 1: General Requirements and its
Amendment No. 1 (1984).
For brevity Part 1 is referred to in this Particular Standard either as the "General Standard"
or as the "General Requirement(s)".
The term "this Standard" is used to make reference to the General Standard and this
Particular Standard taken together.
A requirement of this Particular Standard replacing or modifying requirements of the
General Standard takes precedence over the corresponding General Requirement(s).
Where there is no corresponding clause or sub-clause in this Particular Standard, the clause
or sub-clause of the General Standard applies without modification.

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601-2-8 © I EC 1987
Where it is intended that any part of the General Standard, although possibly relevant, is
X-RAY GENERATORS, a statement to that effect is given in this
not to be applied to therapeutic
Particular Standard.
1.3.102 Superseded I E C Standard
particularly of
X-RAY EQUIPMENT,
This Standard deals with some aspects of therapeutic
and sub-assemblies thereof, that were covered by I E C Publi-
therapeutic X-RAY GENERATORS
cation 407 (1973): Radiation Protection in Medical X-ray Equipment 10 kV to 400 kV.
Within its scope, this Particular Standard supersedes the corresponding requirements of
I E C Publication 407.
1.4 Environmental conditions
a) Transport and storage
Item 2) a)
Replacement:
v) of Sub-clause
an ambient temperature between —20 °C and + 70 °C (see Item
a)
6.1 of the General Standard regarding marking of the packing).
b) Operation
2) Power supply
Item a) A SUPPLY MAINS having:
Replacement of the sixth dash:
a frequency which does not deviate more than 1% from the nominal value for
—
all frequencies.
Replacement of the second paragraph in small print:
An alternating voltage is considered in practice to be sinusoidal if any instantaneous value of the waveform
concerned differs from the instantaneous value of the ideal waveform at the same moment by no more than ±2%
of the peak value of the ideal waveform.
Terminology and definitions
2.
This clause of the General Standard applies except as follows:
Addition:
this Particular Standard, terms in capital letters are used as defined in:
In
— the General Standard
I E C Publication 788 (1984): Medical Radiology—Terminology
—
An index of these terms, referring to the standards mentioned is given in Appendix AA.

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601-2-8 I E C 1987 ©
3. General requirements
This clause of the General Standard applies except as follows:
Additional sub-clause:
3.101 Conventional meaning of electrical quantities
In this Particular Standard unless otherwise indicated, values of X-RAY TUBE VOLTAGE refer
to peak values.
4. General requirements for tests
This clause of the General Standard applies except as follows:
4.1 Type tests and routine tests
a) Type tests
Addition:
The tests described in this Particular Standard are type tests, which are to be carried out
under controlled conditions, usually prevailing only in test laboratories.
4.7 Supply and test voltages, type of current, nature of supply, frequency
Additional item:
in air for compliance
aa) For all tests for the measurement of AIR KERMA and AIR KERMA RATE
and STRAY RADIATION it is assumed that the
with requi
...