EN 60601-2-8:1997/A1:1997

SLOVENSKI STANDARD
01-september-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 - Amendment A1 (IEC
60601-2-8:1987/A1:1997)
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/A1:1997)
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/A1:1997)
Ta slovenski standard je istoveten z: EN 60601-2-8:1997/A1:1997
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
60601-2-8
INTERNATIONAL
STANDARD
AMENDEMENT 1
AMENDMENT 1
1997-08
Amendement 1
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
Amendment 1
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 1997 Droits de reproduction réservés  Copyright - all rights reserved
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
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE S
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-2-8 Amend. 1 © IEC:1997 – 3 –
FOREWORD
This amendment has been prepared by subcommittee 62C: Equipment for radiotherapy,
nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment
in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62C/186/FDIS 62C/193/RVD
Full information on the voting for the approval of this amendment can be found in the report on
voting indicated in the above table.
––––––––
Page 3
CONTENTS
Add, after PREFACE, the following title:
INTRODUCTION
Add the titles of the following new subclauses:
1.3.103 IEC 61217
1.5 Collateral Standards
6.3 Marking of controls and instruments
Replace the title of SECTION TWO by the following:
SECTION TWO – ENVIRONMENTAL CONDITIONS
Replace the title of clause 18 by the following:
18 Protective earthing, functional earthing and potential equalization
Page 5
Add the titles of the following new subclauses:
29.103 Indication of X-RADIATION output
29.104 Agreement between indicated values and effective values
29.105 General test conditions
29.106 Settings for measurements
29.107 Number of measurements
29.108 Measurements and evaluation

60601-2-8 Amend. 1 © IEC:1997 – 5 –
Replace the title of SECTION SIX by the following:
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
Replace the title of SECTION SEVEN by the following:
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
Delete the title of clause 48 and replace it by “Biocompatibility”.

Replace the title of SECTION EIGHT by the following:
SECTION EIGHT – ACCURACY OF OPERATING DATA AND
PROTECTION AGAINST HAZARDOUS OUTPUT
Delete the titles of subclauses 50.1 to 50.104.
Page 7
Delete the title of clause 59.4.
Replace “APPENDIX AA” by “ANNEX AA”.
Add, after ANNEX AA, the following new ANNEX BB:
ANNEX BB – List of standards mentioned in this Particular Standard
Page 9
FOREWORD
Replace the title by the following:
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety of
therapeutic X-ray equipment operating
in the range 10 kV to 1 MV
60601-2-8 Amend. 1 © IEC:1997 – 7 –
Page 9
Replace the foreword and the preface by the following new foreword:
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety of
therapeutic X-ray equipment operating
in the range 10 kV to 1 MV
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 60601-2-8 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this standard is based on the following documents:
Six Months’ Rule Report on voting
62B(CO)49 62B(CO)64
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Subclauses, figures or tables that are additional to those of the General Standard are
numbered starting from 101; additional annexes are lettered AA, etc., and additional items aa),
bb), etc.
Annex AA is for information only.
Annex BB forms an integral part of this standard.

60601-2-8 Amend. 1 © IEC:1997 – 9 –
In this Particular Standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions, in roman type;
– explanations, advice, general statements and exceptions: in small roman type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN LISTED IN ANNEX AA
AND DEFINED IN CLAUSE 2, OR IN THE GENERAL STANDARD 60601-1 AND ITS COLLATERAL
STANDARDS OR IN IEC 60788: SMALL CAPITALS.
Replace, throughout the Standard, the term “X-RAY GENERATOR” by “X-RAY EQUIPMENT”.
Add, after the foreword, the following new introduction:
INTRODUCTION
The use of X-RAY EQUIPMENT for RADIOTHERAPY purposes may expose the PATIENT to danger if
the EQUIPMENT fails to deliver the required dose to the PATIENT, or if the EQUIPMENT design does
not satisfy standards of electrical and mechanical safety. The EQUIPMENT may also cause
danger to persons in the vicinity if the EQUIPMENT itself fails to contain the RADIATION
adequately and/or if there are inadequacies in the design of the TREATMENT ROOM.
This Particular Standard establishes requirements to be complied with by the MANUFACTURERS
in the design and construction of therapeutic X-RAY EQUIPMENT. Clause 29 contains limits
beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE IRRADIATION in order to avoid an
unsafe condition.
Clause 29 does not attempt to define optimum performance requirements. Its purpose is to
identify those features of design that are regarded, at the present time, as essential for the
safe operation of such EQUIPMENT. It places limits on the degradation of EQUIPMENT
performance beyond which it can be presumed that a fault condition exists, e.g. a component
failure, and where an INTERLOCK then operates to prevent continued operation of the
EQUIPMENT.
It should be understood that, before installation, a MANUFACTURER can provide a Compliance
Certificate relating only to TYPE TESTS: data available from SITE TESTS should be incorporated in
the ACCOMPANYING DOCUMENTS, in the form of a SITE TEST report, by those who test the
EQUIPMENT at installation.
Page 11
Replace the title by the following new title:
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety of
therapeutic X-ray equipment operating in
the range 10 kV to 1 MV
60601-2-8 Amend. 1 © IEC:1997 – 11 –
1.1 Scope
Replace the text of this subclause by the following:
Addition:
This Particular Standard applies to therapeutic X-RAY EQUIPMENT with NOMINAL X-RAY TUBE
VOLTAGES in the range 10 kV to 1 MV when connected to alternating current SUPPLY MAINS.
1.2 Object
Replacement:
Replace the first paragraph of this subclause by the following:
This Particular Standard establishes requirements for the safety of therapeutic X-RAY
EQUIPMENT including the requirement 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.
1.3.101 Relation to the General Standard
Replace the first two paragraphs by the following:
This Particular Standard shall be read in conjunction with IEC 60601-1 (1988) and its
amendments 1 (1991) and 2 (1995).
As in the General Standard, the requirements of this Particular Standard are followed by
compliance tests.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. The changes to the text of the General Standard are
SPECIFIED by the use of the following words:
"Replacement" means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
"Addition" means that the text of this Particular Standard is additional to the requirements of
the General Standard.
"Amendment" means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Replace the last paragraph on page 11 and the first paragraph on page 13, by the following
paragraph:
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification. Where it is intended that any part of the General Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard. Unless otherwise stated, all clauses of the General Standard shall apply.

60601-2-8 Amend. 1 © IEC:1997 – 13 –
Page 13
1.3.102 Superseded IEC Standard
Delete this subclause and add the following new subclause 1.3.103:
1.3.103 IEC 61217
This standard defines the designation of EQUIPMENT movements, the marking of scales, their
zero positions, and the direction of movements with increasing values.
1.4 Environmental conditions
Delete this subclause and add the following new subclauses 1.5 to 1.5.104:
1.5 Collateral Standards
1.5.101 IEC 60601-1-1
This Collateral Standard does not apply.
1.5.102 IEC 60601-1-2
ELECTROMAGNETIC COMPATIBILITY (EMC) – Requirements and tests: see clause 36.
1.5.103 IEC 60601-1-3
This Collateral Standard does not apply.
1.5.104 IEC 60601-1-4
NOTE – The Collateral Standard IEC 60601-1-4 and/or a future amendment to the General Standard, with a
consequent amendment to this Particular Standard, will provide a comprehensive treatment of all safety aspects
of PROGRAMMABLE ELECTRONIC SYSTEMS used in therapeutic X-RAY EQUIPMENT.
Page 15
4 General requirements for tests
4.1 Type tests and routine tests
Replace this subclause by the following new subclauses 4.1 and 4.1.101:
4.1 Tests
4.1.101 Test grades
TYPE TEST SITE TEST SPECIFIED
Three grades of and two of procedures are in clause 29 of this
Particular Standard; their requirements are as follows:
• TYPE TEST grade A: An analysis of EQUIPMENT design, as related to the SPECIFIED
RADIATION safety provisions, which shall result in a statement included in the technical
description, regarding the working principles or constructional means by which the
requirement is fulfilled.
60601-2-8 Amend. 1 © IEC:1997 – 15 –
YPE TEST SITE TEST
• T / grade B: Visual inspection or functional test or measurement of the
EQUIPMENT. The test shall be in accordance with the procedure SPECIFIED in this Particular
Standard and shall be based on operating states, including fault condition states, which are
achievable only without interference with the circuitry or construction of the EQUIPMENT.
• TYPE TEST/SITE TEST grade C: Functional test or measurement of the EQUIPMENT. The test
SPECIFIED SITE TEST
shall be in accordance with the principle in this Particular Standard. The
procedure shall be included in the technical description; when the procedure involves
operating states that require interference with the circuitry or the construction of the
EQUIPMENT, the test should be performed by, or under the direct supervision of, the
MANUFACTURER or his agent.
Insert the following subclause 4.6:
4.6 Other conditions
Addition:
aa) SITE TEST information shall be provided in the technical description and shall include
1) statements resulting from TYPE TESTS: grade A;
2) details of and results from TYPE TESTS: grade B and grade C;
3) SPECIFIC SITE TESTS
procedures and test conditions for grade C;
4) instructions on how to generate a described fault condition or, if not practicable, how
to generate a test signal as close as practicable to the source of the signal that would
have generated it, with a statement confirming that the test signal simulates the one that
would be produced in a particular fault condition;
NOTE – In some cases, one test signal may simulate more than one fault condition.
5) instructions on how to reset the EQUIPMENT for NORMAL USE after the completion of the
SITE TEST
and how to verify this condition.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
NOTE – The person responsible for the SITE TESTS should record the results in a report which should be
included with the ACCOMPANYING DOCUMENTS; in addition, the SITE TEST report should contain at least the
following:
• name and address of the USER site;
• MODEL OR TYPE REFERENCE NUMBER and SERIAL NUMBER of the EQUIPMENT;
• name, status and employment address of all personnel taking part in the tests, and date of their
participation;
• environmental and power supply conditions;
• the actual conditions, when test conditions, procedures or devices differ from those given by the
MANUFACTURER, or where the information cannot be derived from this Particular Standard.
4.10 Moisture pre-conditioning treatment
Delete this subclause.
60601-2-8 Amend. 1 © IEC:1997 – 17 –
5 Classification
Replace the text of this clause by the following:
EQUIPMENT and its APPLIED PARTS shall be classified by marking and/or identification as
described in clause 6. This includes the following types of classification:
5.1 According to the type of protection against electric shock:
–CLASS I EQUIPMENT.
5.2 According to the degree of protection against electric shock:
–TYPE B APPLIED PARTS.
5.3 According to the degree of protection against ingress of water detailed in the current
edition of IEC 60529 (see 6.1 l)):
– IPX0, unless otherwise SPECIFIED.
5.4 According to the method(s) of sterilization or disinfection recommended in the
INSTRUCTIONS FOR USE.
5.5 According to the degree of safety of application in the presence of a FLAMMABLE
ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE:
–EQUIPMENT not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE
WITH AIR or WITH OXYGEN OR NITROUS OXIDE.
5.6 According to the mode of operation:
–CONTINUOUS OPERATION WITH INTERMITTENT LOADING, unless otherwise SPECIFIED.
Page 17
6.1 Marking on the outside of the EQUIPMENT or EQUIPMENT parts
Add, after the first paragraph, the following new subclause 6.1 f):
ODEL OR TYPE REFERENCE
6.1 f) M
X-RAY TUBES, X-RAY TUBE HOUSING/ASSEMBLIES shall be supplied to the USER with
ACCOMPANYING DOCUMENTS.
Any information given on the X-RAY TUBE HOUSING shall not differ from that also given in the
ACCOMPANYING DOCUMENTS and shall indicate accurately the data applying to the X-RAY TUBE
assembled in the X-RAY TUBE HOUSING. It shall be the responsibility of the organization
assembling the X-RAY TUBE into the X-RAY TUBE HOUSING to ensure that this information is
accurate, and make such changes as may be necessary in the event of X-RAY TUBE
replacement. See also 29.1.105 f).
X-RAY TUBES shall carry the following markings:
• name or trademark of MANUFACTURER or supplier;
SERIAL NUMBER
• type and .
60601-2-8 Amend. 1 © IEC:1997 – 19 –
RAY TUBE HOUSINGS
X- shall carry the following markings:
• name or trademark of MANUFACTURER
or supplier;
• type and SERIAL NUMBER of X-RAY TUBE HOUSING;
• maximum permissible voltage of X-RAY TUBE HOUSING.
RAY TUBE ASSEMBLIES
X- shall carry the following markings:
• name or trademark of MANUFACTURER
or supplier;
• type and SERIAL NUMBER of X-RAY TUBE;
• maximum permissible X-RAY TUBE VOLTAGE;
• nominal value of the INHERENT FILTRATION OF THE X-RAY TUBE ASSEMBLY in QUALITY
EQUIVALENT FILTRATION;
• position of FOCAL SPOT.
The nominal value of the INHERENT FILTRATION in the SPECIFIED range of operating voltages
shall be indicated in the form of QUALITY EQUIVALENT FILTRATION as follows:
• in thickness of aluminium for therapeutic X-RAY TUBES for operation at voltages within the
range from 10 kV up to and including 150 kV;
• exceptionally, in thickness of beryllium or another substance, e.g. molybdenum, for
therapeutic X-RAY TUBES when the tube window is composed substantially of beryllium or
this other substance;
• in thickness of copper for therapeutic X-RAY TUBES for operation at voltages within the
range from 150 kV up to and including 1 MV.
Where there is a significant variation in INHERENT FILTRATION of the X-RAY TUBE over the entire
range of voltages, this variation should be stated in the ACCOMPANYING DOCUMENTS.
In cases where, for convenience, INHERENT FILTRATION is indicated in thickness of other
material, e.g. iron, the QUALITY EQUIVALENT FILTRATION
of aluminium or copper according to the
operating range of voltages shall also be given.
6.1 m) Mode of operation
Delete this subclause.
Page 19
6.1 t) Cooling conditions
Delete this subclause.
Add the following new subclauses 6.3 and 6.3.101:
6.3 Marking of controls and instruments
6.3.101 Provision of scales and indications for moving parts
Each scaled DISPLAY of any value of a parameter relating to X-RADIATION output that is provided
on the TREATMENT CONTROL PANEL shall have only one scale in a unit of only one kind and/or its
decimal subdivisions.
60601-2-8 Amend. 1 © IEC:1997 – 21 –
EQUIPMENT
Except for hand-held , the following shall be provided:
a) a mechanical scale, or a numerical indication, for each available movement;
b) except when the RADIATION FIELD is limited by a BEAM APPLICATOR, a LIGHT FIELD, with an
indication of the position of the REFERENCE AXIS;
c) a mechanical scale, or a numerical indication, of the RADIATION SOURCE TO SKIN DISTANCE.
The designation, direction of increasing value and zero position of all movements shall comply
with IEC 61217.
Compliance is checked by inspection.
Page 21
6.8.1
General
Delete the second and the third paragraph.
Add “NOTE” before the fourth paragraph and relocate it at the end of the subclause.
6.8.2 INSTRUCTIONS FOR USE
a) General information
Amend the second paragraph to read “.X-RAY TUBE CURRENT.”.
Page 23
ACCOMPANYING DOCUMENTS
6.8.5 Reference to the
Delete this subclause.
Page 25
6.8.101 Statement of compliance
Replace the text of this subclause by the following:
Any statement of compliance of a therapeutic X-RAY EQUIPMENT with this standard shall be
made in the following form:
Therapeutic X-RAY EQUIPMENT.*) IEC 60601-2-8/1997
*) MODEL OR TYPE REFERENCE
Replace the title of SECTION TWO by the following:
SECTION TWO – ENVIRONMENTAL CONDITIONS

60601-2-8 Amend. 1 © IEC:199
...