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  • EN 30993-6 : 1994

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BIOLOGICAL EVALUATION OF MEDICAL DEVICES - TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION

    Available format(s): 

    Superseded date:  01-04-2007

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

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

    Committees responsible
    National foreword
    Foreword
    Introduction
    Method
    1. Scope
    2. Normative references
    3. Common provisions for implantation test methods
    4. Test method for implantation in subcutaneous tissue
    5. Test method for implantation in muscle
    6. Test method for implantation in bone
    Annexes
    A. (informative) Control materials
    B. (informative) Cylindrical specimen
    C. (information) Bibliography
    ZA. (normative) Normative references to international
         publications with their relevant European publications
    Tables
    1. Selection of test periods for short-term implantation
         in subcutaneous tissue and muscle
    2. Selection of test periods for long-term implantation
         in subcutaneous tissue, muscle and bone
    Figure
    B.1 Special cylinder with grooves

    Abstract - (Show below) - (Hide below)

    Specifies test methods for the assessment of the local effects of an implant material on living tissue, at the macroscopic and microscopic level. Coverage includes: common provisions for implantation test methods; test method for implantation in subcutaneous tissue; test method for implantation in muscle; test method for implantation in bone. Also gives tables and annexes.

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

    Committee TC 206
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    I.S. EN 12442-1:2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    BS EN 12442-1:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk
    I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
    BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization
    BS EN 13503-5:2001 Ophthalmic implants. Intraocular lenses Biocompatibility
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    EN 13503-5 : 2001 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - BIOCOMPATIBILITY

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

    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    View more information

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