Skip to content
Please enter a keyword to search

  • ISO 12891-1:2015

    Current The latest, up-to-date edition.

    Retrieval and analysis of surgical implants Part 1: Retrieval and handling

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English

    Published date:  19-06-2015

    Publisher:  International Organization for Standardization

    Add To Cart

    Abstract - (Show below) - (Hide below)

    ISO 12891-1:2015 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. It also provides guidance on infection control.

    NOTE National or other regulations, which can be more stringent, can apply.

    ISO 12891-1:2015 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.

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

    Development Note Supersedes ISO/DIS 12891-1. (06/2015)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    CEN ISO/TR 14969:2005 Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)
    BS ISO 12891-2:2014 Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
    15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
    ASTM F 561 : 2013 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
    BS EN ISO 14630:2012 Non-active surgical implants. General requirements
    I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    BS EN ISO 10993-4:2017 Biological evaluation of medical devices Selection of tests for interactions with blood
    17/30319534 DC : 0 BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS
    04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    AAMI ISO TIR 14969 : 2004 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    CSA ISO TR 14969 : 2005 : R2010 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    ISO 12891-4:2000 Retrieval and analysis of surgical implants Part 4: Analysis of retrieved ceramic surgical implants
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    ISO 12891-3:2000 Retrieval and analysis of surgical implants Part 3: Analysis of retrieved polymeric surgical implants
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS PD ISO/TR 14969 : 2004 AMD 15958 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    03/314215 DC : DRAFT OCT 2003 ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    13/30242622 DC : 0 BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS
    CSA ISO TR 14969 : 2005 : R2015 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    CSA ISO TR 14969 :2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003
    ISO 13019:2018 Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
    ISO 12891-2:2014 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    I.S. CEN ISO TR 14969:2005 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003
    PD CEN ISO/TR 14969:2005 Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003
    ASTM F 3037 : 2015 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
    UNE-EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    I.S. EN ISO 10993-4:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
    ISO 14630:2012 Non-active surgical implants General requirements

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

    ASTM F 561 : 2013 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
    NSF 49 : 2016 BIOSAFETY CABINETRY: DESIGN, CONSTRUCTION, PERFORMANCE, AND FIELD CERTIFICATION
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective