CSA Standards

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures - Second Edition
 N CAN/CSA-C22.2 NO. 60601-2-43:11

Annotation

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular: – equipment for RADIOTHERAPY; – equipment for COMPUTED TOMOGRAPHY; – ACCESSORIES intended to be introduced into the PATIENT; – mammographic X-RAY EQUIPMENT; – dental X-RAY EQUIPMENT.

NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA.

NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements.

NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT when used in cross-sectional imaging mode (sometimes described as CT-like mode or cone-beam CT) is covered by this particular standard and not by IEC 60601-2-44 [2]2. Additional requirements for operation in CT-like mode or cone-beam CT were not considered in the present standard.

INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard.