UNE-EN 60601-2-43:2010/A2:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Endorsed by Asociación Española de Normalización in May of 2020.)
Hardcopy , PDF
English
01-05-2020
01-03-2023
Replace the first sentence of the existing replacement with: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.Replace the third note with the following note: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 3 in subclause 203.6.4.5).Addition after the fourth note: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.
| Committee |
CTN 209/SC 62
|
| DocumentType |
Amendment
|
| Pages |
26
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| SupersededBy |
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