IEC PAS 63077
Good refurbishment practices for medical imaging equipment
|Publication Date:||1 November 2016|
|ICS Code (Diagnostic equipment):||11.040.55|
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 product 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.