IEC PAS 63077:2016 

Good refurbishment practices for medical imaging equipment

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Abstract

IEC PAS 63077:2016(E) 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.

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Relevant for

medical devices


Additional information

Publication typePublicly Available Specification
Publication date2016-11-16
Edition1.0
Available language(s)English
TC/SCTC 62/SC 62B - Diagnostic imaging equipmentrss
ICS11.040.55 - Diagnostic equipment
Stability date  2019
Pages12
File size922 KB

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