Standard Number: IEC 60976-2007
Title: Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
Language: English and French
Publication Date: 2007/10/1
Execute Date: 2007/10/16
Publisher: International Electrotechnical Commission (IEC)
Number of Pages:199P;A4
:This International Standard applies to medical ELECTRON ACCELERATORS when used, for
therapy purposes, in human medical practice.
This standard applies to medical ELECTRON ACCELERATORS which deliver a RADIATION BEAM of
either X-RADIATION or ELECTRON RADIATION with NOMINAL ENERGIES in the range 1 MeV to 50 MeV
at maximum ABSORBED DOSE RATES between 0,001 Gy s–1 and 1 Gy s–1 at 1 m from the
RADIATION SOURCE and at NORMAL TREATMENT DISTANCES between 50 cm and 200 cm from the
The present standard describes measurements and test procedure
s to be performed by the
MANUFACTURER at the design and construction
stage of a medical ELECTRON ACCELERATOR but
does not specify ACCEPTANCE TESTS to be performed after installation at the purchaser's site.
The accompanying report, IEC 60977, however, does suggest that many of the test
procedures are appropriate for ACCEPTANCE TESTS.
The measurement conditions described in the present standard differ from those previously in
use. This applies particularly to the PHANTOM position for measurements and the
measurement of distances from the ISOCENTRE. These new conditions should be substituted
for and not be added to previous methods.
This standard specifies test procedures for the determination and disclosure of functional
performance characteristics, knowledge of which is deemed necessary for proper application
and use of a medical ELECTRON ACCELERATOR and which are to be declared in the
ACCOMPANYING DOCUMENTS together with the greatest deviation or variation to be expected
under specific conditions in NORMAL USE. A format for presentation of functional performance
values is given in Annex A.
It is recognized that inaccuracies in the test methods must be allowed for when assessing
performance. However, it was not felt to be advisable to combine the errors into an overall
performance tolerance but to keep them separate in the expectation that more accurate test
methods will be evolved.
It is not intended that this standard should in any way inhibit the future development of new
designs of equipment which may have operating modes and parameters different from those
described herein, provided that such equipment achieves equivalent levels of performance for
the TREATMENT of PATIENTS.
Except where otherwise stated this standard assumes that the medical ELECTRON
ACCELERATORS have an ISOCENTRIC GANTRY. Where the equipment is non-isocentric, the
description of performance and test methods may need to be suitably adapted.
NOTE A statement of compliance with this standard does not necessarily imply that these tests will be or have been applied as TYPE TESTS or as individual tests.
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Tile in English: Medical electrical equipment - Medical electron accelerators - Functional performance characteristics