scope:

This standard applies to x-ray equipment intended to perform interventional procedures and defines a set of minimum requirements designed to more easily facilitate quality control at the facility level. In particular, items pertinent to the following quality control elements are contained within:

• Physical testing of equipment;

• Electronic audit of system configuration; and,

• Electronic reporting of relevant data and information.

This first edition sets the requirements for fixed x-ray interventional equipment indicated for prolonged x-ray procedures (e.g., neuroradiological and cardiovascular procedures as indicated in the annex AA of IEC 60601-2-43:2010).

The x-ray equipment falling under this standard is hereafter referred to as equipment.