Tuesday, May 28, 2013

New Implants for Surgery Standards for the 1st Quarter 2013

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

  • ASTM F1713, 2008 Reaffirmed in 2013 Edition, Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130)
  • ASTM F1714, 1996 Reaffirmed in 2013 Edition, Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
  • ASTM F1717, 2013 Edition, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F1800, 2012 Edition, Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
  • ASTM F1820, 2013 Edition, Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices
  • ASTM F2028, 2008 Reaffirmed 2013 with an Editorial Change Edition, Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
  • ASTM F2083, 2012 Edition, Standard Specification for Knee Replacement Prosthesis
  • ASTM F2119, 2007 Reaffirmed in 2013 Edition, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • ASTM F2345, 2003 Reaffirmed in 2013 Edition, Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
  • ASTM F2580, 2013 Edition, Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
  • ASTM F2624, 2012 Edition, Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
  • ASTM F2694, 2007 Reaffirmed in 2013 Edition, Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
  • ASTM F2723, 2013 Edition, Standard Test Method for Evaluating Mobile Bearing Knee Tibial Baseplate/Bearing Resistance to Dynamic Disassociation
  • ASTM F543, 2007 Edition with Editorial Change, Standard Specification and Test Methods for Metallic Medical Bone Screws
  • ASTM F562, 2013 Edition, Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
  • ASTM F897, 2002 Reaffirmed in 2013 Edition, Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
  • BS EN ISO 25539-2, 2012 Edition, Cardiovascular implants. Endovascular devices. Vascular stents
  • BS ISO 13175-3, 2012 Edition, Implants for surgery. Calcium phosphates. Hydroxyapatite and beta-tricalcium phosphate bone substitutes
  • BS ISO 14117, 2012 Edition, Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
  • BS ISO 5838-1, 2013 Edition, Implants for surgery. Metallic skeletal pins and wires. General requirements
  • ISO 14708-7, 1st Edition, Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems
  • ISO 5838-1, 3rd Edition, Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements
  • ISO 5840-3, 1st Edition, Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
  • ISO 8637 Amendment 1, Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports

Would you like to see more standards on surgical implants?  Check out our page, Document Center's List of Standards for Implants for Surgery,  Prosthetics, and Orthotics

And if you need any additional assistance in finding the standards you need, just search at our web store, Document Center Inc. or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).