S.R. CR 14060:2000
Superseded
View Superseded by
MEDICAL DEVICE TRACEABILITY
Hardcopy , PDF
English
01-01-2000
12-20-2014
Foreword
Introduction
1 Scope
2 Definition
3 The Distribution Chain
4 Traceability/review of the concept
Bibliography
Presents recommendations for procedures that should be followed to establish, as far as possible, a traceability route for medical devices which have been placed on the market.
| DocumentType |
Standard
|
| Pages |
7
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| CR 14060:2000 | Identical |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
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