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PD IEC/PAS 63077:2016

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Good refurbishment practices for medical imaging equipment
Available format(s)

Hardcopy , PDF

Superseded date

01-03-2020

Language(s)

English

Published date

11-30-2016

Publisher

British Standards Institution

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.

Committee
CH/62/2
DocumentType
Standard
Pages
16
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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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PDF - English
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