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  • BS EN 30993-6:1995

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Superseded date:  31-05-2007

    Language(s):  English

    Published date:  15-04-1995

    Publisher:  British Standards Institution

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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 CH/194
    Development Note Supersedes BS 5736-2(1990) and 92/56764 DC. Also numbered as ISO 10993-6. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    BS 5736-2:1981 Evaluation of medical devices for biological hazards Method of testing by tissue implantation
    ISO 5832-1:2016 Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
    ISO 5832-6:1997 Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
    ISO 5832-5:2005 Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
    ISO 5832-3:2016 Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    ISO 5832-8:1997 Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
    ISO 5832-4:2014 Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
    BS EN 30993-1:1994 Biological evaluation of medical devices Guidance on selection of tests
    NFS 90 703 : 1989 MATERIEL MEDICO-CHIRURGICAL - IMPLANTS CHIRURGICAUX - ESSAIS DE TOLERANCE D'UN BIOMATERIAU DESTINE A ENTRER EN CONTACT AVEC LES TISSUS MUSCULAIRES ET OSSEUX : IMPLANTATIONS A COURT ET LONG TERME
    ISO 5834-2:2011 Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms
    ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    ISO 5832-2:1999 Implants for surgery Metallic materials Part 2: Unalloyed titanium
    ISO 6474:1994 Implants for surgery Ceramic materials based on high purity alumina
    ISO 5832-7:2016 Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
    UNI 9582-3 : 1990 BIOCOMPATIBILITA DI MATERIALI E DISPOSITIVI PER USO MEDICO. PROVA DI IMPIANTO NELL'OSSO.
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