Wednesday, July 17, 2013

New Implants for Surgery, Prosthetics and Orthotics Standards for the 2nd Quarter 2013

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

  • ASTM F138, 2013 Edition, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (Uns S31673)
  • ASTM F1314, 2013 Edition, Standard Specification for Wrought Nitrogen Strengthened 22 Chromium–13 Nickel–5 Manganese–2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (Uns S20910) 
  • ASTM F1714, 1996 Edition Reaffirmed in 2013, Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
  • ASTM F2083, 2012 Edition, Standard Specification for Knee Replacement Prosthesis
  • ASTM F2146, 2013 Edition, Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (Uns R56320)
  • ASTM F2345, 2003 Edition Reaffirmed in 2013, Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
  • ASTM F2989, 2013 Edition, Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications
  • BS EN ISO 13356, Corrigenda 1 for 2009 Edition, Implants for Surgery. Ceramic Materials Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP)
  • BS EN ISO 5840-3, 2013 Edition, Cardiovascular Implants. Cardiac Valve Prostheses. Heart Valve Substitutes Implanted by Transcatheter Techniques
  • BS ISO 13175-3, 2012 Edition, Implants for Surgery. Calcium Phosphates. Hydroxyapatite and Beta-Tricalcium Phosphate Bone Substitutes
  • DIN EN ISO 14630, 2013 Edition, Non-Active Surgical Implants - General Requirements (ISO 14630:2012)
  • ISO 5841-3, 3rd Edition, Implants for Surgery - Cardiac Pacemakers - Part 3: Low-Profile Connectors (IS-1) for Implantable Pacemakers
  • ISO 8637, Amendment 1 for the 3rd Edition, Amendment 1: Revision To Figure 2 - Main Fitting Dimensions of Dialysis Fluid Inlet and Outlet Ports

If you'd like to see more standards like this, please review our Document Center List of Standards on Implants for Surgery, Prosthetics and Orthotics.

With FDA requirements and the European Medical Directives, standards for medical device manufacturers have become the backbone of many company compliance documentation collections.  Why?  Reliance on standards is another method for minimizing the liabilities associated with the development and sales of medical devices.  Document Center customers require superior notification and current awareness services to insure that their products continue to be well received in markets around the world.  

Why do so many Medical Device Manufacturers rely on Document Center for their standards?  We're the source that provides the documents, services and support required to meet the exacting requirements for these organizations.  Make Document Center Your Standards Experts and find out why we're the best in the business!