NEN-EN-IEC 60601-2-43/A2
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
active, Most Current
| Organization: | NEN |
| Publication Date: | 1 May 2020 |
| Status: | active |
| Page Count: | 46 |
| ICS Code (Radiographic films): | 37.040.25 |
| 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).
2 Figures in square brackets refer to the Bibliography.
Document History
NEN-EN-IEC 60601-2-43/A2
May 1, 2020
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
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...
May 1, 2018
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
A description is not available for this item.
August 1, 2014
Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
A description is not available for this item.
June 1, 2010
Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
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,...
February 1, 2001
Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures
Applies to X-ray equipment declared by the manufacturer to be suiteable for prolonged radioscopically guided interventional procedures.