PD IEC/PAS 63077:2016

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for refurbishment of used
  medical devices
5 Specific requirements for good refurbishment
  practice
Bibliography

Specifies 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.

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.