CSA - CAN/CSA-C22.2 NO. 60601-2-43:11 AMD 2
Medical electrical equipment — Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
Organization: | CSA |
Publication Date: | 1 January 2021 |
Status: | inactive |
Page Count: | 38 |
ICS Code (Radiographic equipment): | 11.040.50 |
scope:
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]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5).
The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
2) Figures in square brackets refer to the Bibliography.
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