Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
|Publication Date:||1 May 2020|
|ICS Code (Radiographic films):||37.040.25|
|ICS Code (Radiographic equipment):||11.040.50|
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT.
NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 18.104.22.168).
2 Figures in square brackets refer to the Bibliography.