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

    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

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    Pertains to medical devices, active implantable medical devices and in vitro diagnostic medical devices, including their accessories.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes SR CR 14060. (01/2015)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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