Thursday, January 16, 2014

New Implants for Surgery, Prosthetics and Orthotics Standards for the 4th Quarter 2013

Document Center Inc. is pleased to announce that the following New Standards for Implants for Surgery, Prosthetics and Orthotics have been released:
  • ASTM F136, 2013 Edition, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
  • ASTM F138, 2013a Edition, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
  • ASTM F543, 2013 Edition with Editorial Correction, Standard Specification and Test Methods for Metallic Medical Bone Screws
  • ASTM F560, 2013 Edition with Editorial Correction, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
  • ASTM F561, 2013 Edition, Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
  • ASTM F565, 2004 Edition reaffirmed in 2013, Standard Practice for Care and Handling of Orthopedic Implants and Instruments
  • ASTM F983, 1986 Edition reaffirmed in 2013, Standard Practice for Permanent Marking of Orthopaedic Implant Components
  • ASTM F1314, 2013a Edition with Editorial Corrections, Standard Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
  • ASTM F1408, 1997 Edition reaffirmed in 2013, Standard Practice for Subcutaneous Screening Test for Implant Materials
  • ASTM F1439, 2003 Edition reaffirmed in 2013, Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
  • ASTM F2102, 2013 Edition, Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
  • BS 7251-10, Withdrawn and replaced by BS ISO 7206-6, Orthopaedic joint prostheses.  Method of determination of endurance properties of the head and neck region of stemmed femoral components of hip joint prostheses
  • BS ISO 7206-6, 2013 Edition, Implants for surgery. Partial and total hip joint prostheses. Endurance properties testing and performance requirements of neck region of stemmed femoral components
  • BS ISO 15309, 2013 Edition, Implants for surgery. Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
  • BS ISO 16087, 2013 Edition, Implants for surgery. Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
  • ISO 7206-6, 2nd Edition, 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 15309, 1st Edition, Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
  • ISO 16087, 1st Edition, Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants




And you'll want to review my previous blogs:



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