Full Description

IEC PAS 63077 Ed. 1.0 b:2016 describes and defines the process of refurbishment of used medical imagingequipment and applies to the restoring of used medical imaging equipment to a condition ofsafety and effectiveness comparable to that of new equipment. This restoration includesactions such as repair, rework, software/hardware updates, and the replacement of worn partswith original parts. This document enumerates the actions that must be performed and themanner consistent with product specifications and service procedures required to ensure thatthe refurbishment of medical imaging equipment is done without changing the finishedmedical imaging equipment's performance, safety specifications, or intended use according toits original or applicable valid registration.

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Edition: 1.0 Published: 11/13/2019 Number of Pages: 33 File Size: 1 file , 1.1 MB