BS PD IEC/PAS 63077:2016

BS PD IEC/PAS 63077:2016 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.


Cross References:
ISO 13485:2016
ISO 14971:2007
IEC 60601-1:2005
IEC 60601-1:2005/AMD1:2012
IEC 62353:2014
US FDA 21 CFR Part 820


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