Skip to content
Please enter a keyword to search

  • 17/30319534 DC : 0

    NA Status of Standard is Unknown

    BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

    Add To Cart

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

    Foreword
    1 Scope
    2 Normative References
    3 Terms and definitions
    4 General and Principle
    5 Apparatus
    6 Preparation of parallel test samples from test
      samples
    7 Procedure
    8 Test report
    9 Evaluation
    Annex A (informative) - Flowchart of the overall procedure
            steps
    Annex B (informative) - Reagents
    Annex C (informative) - Procedure for pre-treatment
            (Option)
    Annex D (informative) - Procedure for extraction
            of sGAG (Option)
    Annex E (informative) - Example of test report format
            for sGAG measurement
    Bibliography

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

    Comment Closes On
    Committee RGM/1
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
    ASTM F 2312 : 2011 : REDLINE Standard Terminology Relating to Tissue Engineered Medical Products
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    ASTM F 2212 : 2011 : REDLINE Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ASTM F 2383 : 2011 : REDLINE Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
    ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
    ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1: Retrieval and handling
    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