Skip to content
Please enter a keyword to search

  • BS ISO 14949:2001

    Current The latest, up-to-date edition.

    Implants for surgery. Two-part addition-cure silicone elastomers

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  20-11-2001

    Publisher:  British Standards Institution

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and conditions
    4 Formulation
       4.1 Composition
       4.2 Raw materials assessment
    5 Biocompatibility
    6 Characterization and testing
       6.1 Test slab preparation
       6.2 Identification
       6.3 Purity testing
       6.4 Cure rate
       6.5 Physicomechanical properties and characterization
    7 Documentation
       7.1 Data sheet
       7.2 Certificate of analysis
    Annex A (normative) Determination of substances soluble in
                        hexane
    Annex B (normative) Determination of volatile matter
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the characteristics of and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical implants.

    Scope - (Show below) - (Hide below)

    This International Standard specifies the characteristics of, and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical implants.

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

    Committee CH/150/1
    Development Note Supersedes 00/561661 DC. (12/2001)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 34-1:2015 Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces
    ISO 6502:2016 Rubber Guide to the use of curemeters
    ISO 527-2:2012 Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 9001:2015 Quality management systems — Requirements
    ISO 14969:1999 Quality systems Medical devices Guidance on the application of ISO 13485 and ISO 13488
    ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
    ISO 3417:2008 Rubber Measurement of vulcanization characteristics with the oscillating disc curemeter
    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