IEC 61223-3-1 1st Edition, March 1, 1999
Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1: Acceptance Tests - Imaging Performance of X-Ray Equipment for Radiographic and Radioscopic Systems
Additional Comments: BILINGUAL * W/D NO S/S
Published By:International Electrotechnical Commission (IEC)
This part of IEC 61223 applies to those components of X-RAY EQUIPMENT which influence the image quality and PATIENT dose of diagnostic X-ray systems using radiographic and radioscopic imaging systems.
This standard applies to the performance of X-RAY EQUIPMENT in the ACCEPTANCE TEST on the following medical diagnostic X-RAY EQUIPMENT and ASSOCIATED EQUIPMENT:
– radiography equipment, for example:
• stationary radiography EQUIPMENT;
• mobile radiography EQUIPMENT;
• skull radiography EQUIPMENT;
• lung radiography EQUIPMENT;
• TOMOGRAPHY EQUIPMENT – excluding COMPUTED TOMOGRAPHY;
• radiography devices (SPOTFILM DEVICES) in RADIOSCOPY EQUIPMENT;
• 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 testing.
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 specifications.
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.