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NSAI
I.S. EN IEC 63077:2019

I.S. EN IEC 63077:2019

Current

Current

The latest, up-to-date edition.

Good refurbishment practices for medical imaging equipment (IEC 63077:2019)

Available format(s)

Hardcopy , PDF

Language(s)

English - French

Published date

01-08-2020

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT
5 Specific requirements for good REFURBISHMENT practice
Annex A (informative) Cross reference list of the contents of IEC 63077 versus ISO 13485
Bibliography

This document 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 performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use.

Committee
SC 62B
DocumentType
Standard
ISBN
978-2-8322-7595-5
Pages
48
ProductNote
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO :IEC TR 60788
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
IEC 63077:2019 Identical
EN IEC 63077:2019 Identical

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Hardcopy - English - French
PDF - English - French
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