Monday, March 6, 2017

New Implants for Surgery, Prosthetics, and Orthotics Standards for the 4th Quarter 2016

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


  • ASTM F603, 2012 Edition Reapproved in 2016, Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
  • ASTM F1295, 2016 Edition, Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
  • ASTM F1582, 1998 Edition Reapproved in 2016, Standard Terminology Relating to Spinal Implants
  • ASTM F1851, 2009 Edition Reapproved in 2016, Standard Specification for Composition of Anorganic Bone for Surgical Implants
  • ASTM F2027, 2016 Edition, Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
  • ASTM F2393, 2012 Edition Reapproved in 2016, Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications
  • ASTM F2401, 2016 Edition, Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices
  • ASTM F2423, 2011 Edition Reapproved in 2016, Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
  • ASTM F2624, 2012 Edition Reapproved in 2016, Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
  • BS 7252-7, Withdrawn and Replaced by BS ISO 5832-7, Metallic materials for surgical implants. Specification for cobalt-chromium-nickel-molybdenum-iron alloy
  • BS EN ISO 1832-3, 2016 Edition, Implants for surgery. Metallic materials. Wrought titanium 6-aluminium 4-vanadium alloy
  • BS ISO 5832-7, 2016 Edition, Implants for surgery. Metallic materials. Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
  • BS ISO 7206-2, 2011 Edition with Amendment 1, Implants for surgery. Partial and total hip joint prostheses. Articulating surfaces made of metallic, ceramic and plastics materials
  • ISO 5832-3, 4th Edition, Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
  • ISO 5832-7, 3rd Edition, Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
  • ISO 7199, 3rd Edition, Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
  • ISO 21535-AM1, Amendment 1 for 2nd Edition, Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants