• radiography devices (SPOTFILM DEVICES) in RADIOSCOPY
• angiography EQUIPMENT (excluding DSA function);
• CINERADIOGRAPHY equipment;
– RADIOSCOPY EQUIPMENT, including:
• combined radiographic and radioscopic EQUIPMENT.
This standard applies to the generation of X-RADIATION and
ACCESSORIES of digital systems. It does not apply to any digital
image acquisition or image processing parts of the above mentioned
diagnostic X-RAY EQUIPMENT.
NOTE – Since the characterization of digital detectors and image
processing is still under development, this will be included in a
later edition of this standard.
This standard does not apply to mammographic X-RAY EQUIPMENT,
RADIOTHERAPY simulators, nor to dental X-RAY EQUIPMENT.
This standard defines:
a) the parameters which describe the performance of X-RAY
EQUIPMENT with regard to imaging properties and PATIENT dose;
b) methods of testing whether measured quantities related to
those parameters comply with the specified tolerances.
These methods rely mainly on non-invasive measurements, using
appropriate test equipment, performed during or after the
installation is completed. Signed statements covering steps of
product testing at the MANUFACTURER's site or during the
installation procedure can be used as part of the acceptance
The aim is to verify compliance of the installation with
specifications relating to the image quality and PATIENT dose, and
to detect malfunctions that are not in agreement with those
This standard does not specify tolerances for the parameters
under investigation. Nor does it consider:
c) aspects of mechanical and electrical safety,
d) aspects of mechanical, electrical and software performance
unless they are essential to the performance of the tests directly
affecting image quality and PATIENT dose.
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