• BS ISO 16054 : 2000 AMD 14017

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    IMPLANTS FOR SURGERY - MINIMUM DATA SETS FOR SURGICAL IMPLANTS

    Available format(s): 

    Superseded date:  07-01-2003

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    3.1 implantable medical device
    3.2 implant event
    3.3 explant event
    3.4 medical facility
    4 Data sets
    4.1 General
    4.2 Supplier data
    4.3 Medical facility data
    Annex A (informative) Automated device
            labelling and data capture

    Abstract - (Show below) - (Hide below)

    This standard defines minimum data sets for surgical implants to facilitate recording and international exchange of data for the purposes of implant registry and tracking to allow recall for product correction or partient follow up in the event of unforeseen device malfunction. The minimum data set also fulfills the core data requirements to allow cross referencing between extended data sets for the purposes of retrieval analysis and research. This International standard is applicable to manufacturers and distributors of medical devices intended for permanent implant, i.e. means more than 30 days and to those hospitals and other medical facilities which carry out implant procedures.

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    Committee CH/49
    Development Note Renumbered and superseded by BS EN ISO 16054. (01/2003)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 8402:1994 Quality management and quality assurance — Vocabulary
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