DIN EN IEC 63077:2021 Edition
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Good refurbishment practices for medical imaging equipment (Draft)
Published By | Publication Date | Number of Pages |
DIN | 2021-06 | 41 |
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 effectiveness comparable to that of new equipment. 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 must be 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.