Jetzt auswählen und bestellen
50,25 €
exkl. USt.
Konfigurieren
Norm
OVE EN IEC 63077
Ausgabedatum: 2023 11 01
Good refurbishment practices for medical imaging equipment (( IEC 63077:2019) EN IEC 63077:2019) (english version)
This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a con...
Weiterlesen
Gültig
Herausgeber:
Österreichischer Verband für Elektrotechnik
Format:
Digital | 22 Seiten
Sprache:
Englisch
ICS
This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT`s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration.
OVE EN IEC 63077
2023 11 01
Good refurbishment practices for medical imaging equipment (( IEC 63077:2019) EN IEC 63077:2019) (en...
Norm
↖
Norm
ISO 13485:2016
Ausgabedatum :
2016 02 25
Medical devices — Quality management systems — Requirements for regulatory purposes
Norm
ISO 14971:2007
Ausgabedatum :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)