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New Implants for Surgery, Prosthetics, and Orthotics Standards for the 1st Quarter 2017

Kyle Bach

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

  • ASTM F451, 2016 Edition,Standard Specification for Acrylic Bone Cement
  • ASTM F1058, 2016 Edition, Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008)
  • ASTM F1264,  2016 Edition with Editorial Correction, Standard Specification and Test Methods for Intramedullary Fixation Devices
  • ASTM F1635, 2016 Edition, Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
  • ASTM F2129, 2017 Edition, Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
  • ASTM F2183, Withdrawn Without Replacement, Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants
  • ASTM F2694, 2016 Edition, Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
  • ASTM F2902, 2016 Edition,Standard Guide for Assessment of Absorbable Polymeric Implants
  • BS EN 12006-2, Withdrawn and Replaced by BS EN ISO 7198, Non active surgical implants. Particular requirements for cardiac and vascular implants. Vascular prostheses including cardiac valve conduits
  • BS EN 50527-1, 2016 Edition, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. General
  • BS EN 50527-2-1, 2016 Edition, Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. Specific assessment for workers with cardiac pacemakers
  • BS EN ISO 7198, 2017 Edition, Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
  • BS EN ISO 7199, 2017 Edition, Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
  • BS EN ISO 21535, 2009 Edition with Amendment 1, Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
  • BS EN ISO 25539-1, 2017 Edition, Cardiovascular implants. Endovascular devices. Endovascular prostheses
  • BS ISO 7198, Withdrawn and Replaced by BS EN ISO 7198, 
  • ISO 25539-1, 2nd Edition, Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses








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