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New Implants for Surgery Standards for the 3rd Quarter 2017

Kyle Bach

Document Center Inc.
is pleased to announce that the following New Standards on Implants for Surgery are now available:

  • AAMI/ISO 25539-1, 2017 Edition, Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
  • ANSI/AAMI/ISO 255391, Please refer to AAMI/ISO 25539-1, Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses
  • ASTM F1538, 2003 Edition Reapproved in 2017, Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
  • ASTM F1634, Withdrawn with no replacement, Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
  • ASTM F1831, 2017 Edition, Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
  • ASTM F2102, 2017 Edition, Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
  • ASTM F2581, 2012 Edition Reapproved in 2017, Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)
  • ASTM F3141, 2017 Edition, Standard Guide for Total Knee Replacement Loading Profiles
  • ASTM F621, 2012 Edition Reapproved in 2017, Standard Specification for Stainless Steel Forgings for Surgical Implants
  • ASTM F982, Withdrawn with no replacement, Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
  • BS ISO 11491, 2017 Edition, Implants for surgery. Determination of impact resistance of ceramic femoral heads for hip joint prostheses
  • BS ISO 13781, 2017 Edition, Implants for surgery. Homopolymers, copolymers and blends on poly(lactide). In vitro degradation testing
  • BS ISO 19213, 2017 Edition, Implants for surgery. Test methods of material for use as a cortical bone model
  • BS ISO 21063, 2017 Edition, Prosthetics and orthotics. Soft orthoses. Uses, functions, classification and description
  • BS ISO 21064, 2017 Edition, Prosthetics and orthotics. Foot orthotics. Uses, functions classification and description
  • BS ISO 21065, 2017 Edition, Prosthetics and orthotics. Terms relating to the treatment and rehabilitation of persons having a lower limb amputation
  • BS ISO 212063, 2017 Edition, Prosthetics and orthotics. Soft orthoses. Uses, functions, classification and description 
  • ISO 13781, 2nd Edition, Implants for surgery – Homopolymers, copolymers and blends on poly(lactide) – In vitro degradation testing
  • ISO 19213, 1st Edition, Implants for surgery – Test methods of material for use as a cortical bone model
  • ISO 21063, 1st Edition, Prosthetics and orthotics – Soft orthoses – Uses, functions, classification and description
  • ISO 21064, 1st Edition, Prosthetics and orthotics – Foot orthotics – Uses, functions classification and description
  • ISO 21065, 1st Edition, Prosthetics and orthotics – Terms relating to the treatment and rehabilitation of persons having a lower limb amputation
  • ASTM F701, Withdrawn with no replacement, Standard Practice for Care and Handling of Neurosurgical Implants and Instruments (Withdrawn 2017)  

For more standards like these, please refer to our Document Center List of Implants for Surgery Standards.