Tuesday, October 22, 2013

New Implants for Surgery, Prosthetics and Orthotics Standards for the 3rd Quarter 2013

Document Center Inc. is please to announce that the following New Standards on Implants for Surgery, Prosthetics and Orthotics are now available:

  • ANSI/AAMI/ISO 5840-3, 2012 Edition, Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
  • ANSI/AAMI/ISO 8637 Amendment 1, Cardiovascular implants and extracorporeal systems - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators
  • ASTM F67, 2013 Edition, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
  • ASTM F86, 2013 Edition, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
  • ASTM F543, 2013 Edition, Standard Specification and Test Methods for Metallic Medical Bone Screws
  • ASTM F648, 2013 Edition, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
  • ASTM F1377, 2013 Edition, Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
  • ASTM F1586, 2013(e1) Edition, Standard Specification for Wrought Nitrogen Strengthened 21Chromium-10Nickel-3Manganese-2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)
  • ASTM F2565, 2013 Edition, Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
  • ASTM F2723, 2013a Edition, Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation

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