BS EN 61223-3-3:1997

This standard BS EN 61223-3-3:1997 Evaluation and routine testing in medical imaging departments is classified in these ICS categories:

• 11.040.50 Radiographic equipment

1.1 Scope

This part of IEC 1223 applies to those components of X-ray equipment which influence the image quality of equipment for digital subtraction angiography (DSA) with an imaging system consisting of an X-ray generation subsystem, a detection device comprising an X-ray image intensifier television chain, means of digitization and digital image processing, image storage and image manipulation including subtraction, and facilities for image display.

This standard does not apply to general equipment of digital imaging. If such an equipment includes a DSA function, it is restricted to the DSA function.

1.2 Object

This part of IEC 1223 defines:

1. the essential parameters which describe the performance of the above-mentioned components of X-ray equipment with regard to imaging properties;

2. methods of testing whether measured quantities related to those parameters comply with specified tolerances.

These methods mainly rely on non-invasive measurements using appropriate test equipment performed during the installation or after the installation is completed. Signed statements covering steps in the installation procedure can be used as part of acceptance testing.

The aim is to verify compliance of the installation with specifications affecting the image quality, and to detect malfunctions affecting the image quality that are not in agreement with those specifications.

This standard does not in itself specify tolerances for the parameters under investigation. Neither is it intended to consider:

1. aspects of mechanical and electrical safety;

2. aspects of mechanical, electrical and software performance unless they are essential to the performance of the tests directly affecting the image quality.