CEN/CLC/TR 14060:2014
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical device traceability enabled by unique device identification (UDI)
26-08-2022
03-12-2014
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
This Technical Report describes the current situation for medical device traceability in Europe and identifies key elements to establish a comprehensive European traceability system that would provide full traceability to the individual patient level.This Technical Report applies to medical devices, active implantable medical devices and in vitro diagnostic medical devices, including their accessories. Other devices which are custom-made or intended for clinical investigations and those in vitro diagnostic medical devices which are manufactured in health institutions and for performance evaluation are out of the scope of this document.
| Committee |
CEN/CLC/JTC 3
|
| DevelopmentNote |
Supersedes CR 14060. (01/2015) Supersedes UNE CR 14060. (04/2015)
|
| DocumentType |
Technical Report
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| S.R. CEN/CLC/TR 14060:2014 | Identical |
| NEN NPR CEN CLC/TR 14060 : 2014 | Identical |
| UNE-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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