S.R. CEN/CLC/TR 14060:2014
Current
The latest, up-to-date edition.
MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI)
Hardcopy , PDF
English
01-01-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Manufacturer
4 Intermediate trading partner
5 Internal traceability - Key elements for users
6 Sharing information
Annex A (informative) - International activity on UDI
Bibliography
Pertains to medical devices, active implantable medical devices and in vitro diagnostic medical devices, including their accessories.
| DevelopmentNote |
Supersedes SR CR 14060. (01/2015)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| CEN/CLC/TR 14060:2014 | Identical |
| ISO 16054:2000 | Implants for surgery Minimum data sets for surgical implants |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 28001:2007 | Security management systems for the supply chain Best practices for implementing supply chain security, assessments and plans Requirements and guidance |
| EN ISO 16054:2002 | Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000) |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| 765/2008 : 2008 COR 1 2015 | REGULATION (EC) NO 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 9 JULY 2008 SETTING OUT THE REQUIREMENTS FOR ACCREDITATION AND MARKET SURVEILLANCE RELATING TO THE MARKETING OF PRODUCTS AND REPEALING REGULATION (EEC) NO 339/1993 (TEXT WITH EEA RELEVANCE) |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN ISO 22005:2007 | Traceability in the feed and food chain - General principles and basic requirements for system design and implementation (ISO 22005:2007) |
| ISO 21849:2006 | Aircraft and space Industrial data Product identification and traceability |
| ISO 22005:2007 | Traceability in the feed and food chain General principles and basic requirements for system design and implementation |
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