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  • BS EN 12010:1998

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Non-active surgical implants. Joint replacement implants. Particular requirements

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2008

    Language(s):  English

    Published date:  15-07-1998

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Intended performance
    5 Design attributes
    6 Materials
    7 Design evaluation
    8 Manufacture and inspection
    9 Sterilization
    10 Packaging
    11 Information supplied by the manufacturer
    Annex A (informative) List of materials found acceptable
    for the manufacture of implants
    Annex B (informative) List of materials found acceptable or
    not acceptable for articulating surfaces of implants
    Annex C (informative) List of materials found acceptable or
    non-acceptable for metallic combinations for nonarticulating
    contacting surfaces of implants
    Annex D (informative) Bibliography
    Annex ZA (informative) Clauses of this European Standard
    addressing essential requirements or other provisions of
    EU Directives

    Abstract - (Show below) - (Hide below)

    Defines particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement. Defines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturers.

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

    Committee CH/150/4
    Development Note Supersedes 95/561848 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    BS 6324-3:1983 Terms relating to surgical implants Glossary of terms relating to materials
    ISO 5832-1:2016 Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
    BS 6324-2:1983 Terms relating to surgical implants Glossary of terms relating to mechanics
    ISO 5834-1:2005 Implants for surgery Ultra-high-molecular-weight polyethylene Part 1: Powder form
    ISO 5832-11:2014 Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
    ISO 7206-8:1995 Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion
    ISO 5832-6:1997 Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
    ASTM F 1351 : 1996 Standard Practice for Determination of the Effect of Hard Creasing Paper on Images Produced by Business Imaging Systems
    ISO 5832-5:2005 Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
    BS 6324-5:1990 Terms relating to surgical implants Guidance on the usage of the terms \'valgus\' and \'varus\' in orthopaedic surgery
    ISO 5832-3:2016 Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
    ISO 7206-5:1992 Implants for surgery Partial and total hip joint prostheses Part 5: Determination of resistance to static load of head and neck region of stemmed femoral components
    ISO 5832-10:1996 Implants for surgery — Metallic materials — Part 10: Wrought titanium 5-aluminium 2,5-iron alloy
    ISO 7206-4:2010 Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components
    ISO 7206-9:1994 Implants for surgery Partial and total hip joint prostheses Part 9: Determination of resistance to torque of head fixation of stemmed femoral components
    ASTM F 370 : 1994 : R1999 Standard Specification for Proximal Femoral Endoprosthesis (Withdrawn 2005)
    ISO 7206-6:2013 Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
    ISO 5832-8:1997 Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
    ISO/TR 9326:1989 Implants for surgery Partial and total hip joint prostheses Guidance for laboratory evaluation of change of form of bearing surfaces
    ISO 13356:2015 Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
    ISO/TR 9325:1989 Implants for surgery Partial and total hip joint prostheses Recommendations for simulators for evaluation of hip joint prostheses
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 9584:1993 Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
    ISO 7207-2:2011 Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials
    ISO 5833:2002 Implants for surgery — Acrylic resin cements
    ISO 5832-4:2014 Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
    BS 6324-1:1983 Terms relating to surgical implants Glossary of general medical terms
    ISO 9583:1993 Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants
    ISO 5834-2:2011 Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms
    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
    ASTM F 1223 : 2014 : REDLINE Standard Test Method for Determination of Total Knee Replacement Constraint
    ISO 7206-2:2011 Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
    ISO 8828:2014 Implants for surgery Guidance on care and handling of orthopaedic implants
    ISO 7207-1:2007 Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions
    ISO 6018:1987 Orthopaedic implants General requirements for marking, packaging and labelling
    ISO 7206-1:2008 Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
    ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
    ISO 5832-12:2007 Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    ISO 5832-9:2007 Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel
    BS 6324-4:1983 Terms relating to surgical implants Glossary of orthopaedic surgical terms
    NFS 94 065 : 1998 MATERIALS FOR SURGICAL IMPLANTS - DETERMINATION OF ARSENIC, MERCURY, CADMIUM AND LEAD ON COATINGS BASED ON PHOSPHATE OF CALCIUM
    ISO 5839:1985 Implants for surgery Orthopaedic joint prostheses Basic requirements
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