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S.R. CEN/CLC/TR 14060:2014

Current
Current

The latest, up-to-date edition.

MEDICAL DEVICE TRACEABILITY ENABLED BY UNIQUE DEVICE IDENTIFICATION (UDI)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Publisher

National Standards Authority of Ireland

Preview

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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PDF - English
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