CEI EN 60601-2-43
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
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| Organization: | CEI |
| Publication Date: | 1 September 2020 |
| Status: | active |
| Page Count: | 26 |
| 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
CEI EN 60601-2-43
September 1, 2020
Medical electrical equipment Part 2: 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...
September 1, 2018
Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
Collateral standards
Replace the existing second sentence of the second paragraph by the following:
IEC 60601-1-8, IEC 60601-1-101), IEC 60601-1-112) and IEC 60601-1-123) do not apply.
October 1, 2014
Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
A description is not available for this item.
August 1, 2011
Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
La presente Norma Particolare stabilisce i requisiti per la sicurezza fondamentale e per le prestazioni essenziali, per la progettazione e la costruzione di apparecchiature a raggi X usate per le...
July 1, 2002
Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray equipment for interventional procedures
E’ molto diffuso l’utilizzo di apparecchiature a raggi X per le procedure radiologiche interventistiche sotto controllo radioscopico. Questi esami possono utilizzare irradiazioni prolungate e possono...