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New Implants For Surgery, Prosthetics And Orthotics Standards for the 1st Quarter 2015

Kyle Bach

Document Center Inc. is pleased to announce that the following New Standards on Implants For Surgery, Prosthetics And Orthotics are now available:


  • AAMI/ISO TIR37137, 2014 Edition, Cardiovascular biological evaluation of medical devices – Guidance for absorbable implants
  • ASTM F90, 2014 Edition, Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
  • ASTM F382, 2014 Edition, Standard Specification and Test Method for Metallic Bone Plates
  • ASTM F1108, 2014 Edition, Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
  • ASTM F1264, 2014 Edition, Standard Specification and Test Methods for Intramedullary Fixation Devices
  • ASTM F1357, 2014 Edition, Standard Specification for Articulating Total Wrist Implants
  • ASTM F1472, 2014 Edition, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
  • ASTM F1983, 2-14 Edition, Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
  • ASTM F2064, 2014 Edition, Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
  • ASTM F2181, 2014 Edition, Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
  • ASTM F2257, 2014 Edition, Standard Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
  • ASTM F2722, 2015 Edition, Standard Practice for Evaluating Mobile Bearing Knee Tibial Baseplate Rotational Stops
  • BS EN ISO 7199, Corrigendum 1 for 2009 Edition, Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
  • ISO 13405-1, 2nd Edition, Prosthetics and orthotics – Classification and description of prosthetic components – Part 1: Classification of prosthetic components
  • ISO 13405-2, 2nd Edition, Prosthetics and orthotics – Classification and description of prosthetic components – Part 2: Description of lower limb prosthetic components
  • ISO 13405-3, 2nd Edition, Prosthetics and orthotics – Classification and description of prosthetic components – Part 3: Description of upper limb prosthetic components
  • ISO 13779-6, 1st Edition, Implants for surgery – Hydroxyapatite – Part 6: Powders
  • ISO 29783-2, 1st Edition, Prosthetics and orthotics – Vocabulary – Part 2: Prosthetic gait



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