PD IEC/PAS 63077:2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Good refurbishment practices for medical imaging equipment
Hardcopy , PDF
03-01-2020
English
30-11-2016
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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.
| Committee |
CH/62/2
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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.
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| IEC 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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