Thursday, July 10, 2014

New Implants for Surgery, Prosthetics and Orthotics Standards for the 2nd Quarter 2014

Document Center Inc. is pleased to announce that the following New Standards on Implants for Surgery, Prosthetics and Orthotics are now available:
  • ASTM F648, 2014 Edition, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
  • ASTM F1672, 2014 Edition, Standard Specification for Resurfacing Patellar Prosthesis
  • ASTM F1904, 2014 Edition, Standard Practice for Testing the Biological Responses to Particles in vivo
  • ASTM F2224, 2009 Edition Reaffirmed in 2014, Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
  • ASTM F2514, 2008 Edition Reaffirmed in 2014, Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
  • ASTM F2582, 2014 Edition, Standard Test Method for Impingement of Acetabular Prostheses
  • ASTM F2606, 2008 Edition Reaffirmed in 2014, Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems
  • ASTM F2724, 2008 Edition Reaffirmed in 2014, Standard Test Method for Evaluating Mobile Bearing Knee Dislocation
  • ASTM F2943, 2014 Edition, Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
  • BS EN ISO 8637, 2014 Edition, Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
  • BS EN ISO 8638, 2014 Edition, Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
  • BS EN ISO 21536, 2009 Edition with Amendment 1, Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants
  • BS ISO 13179-1, 2014 Edition, Implants for surgery. Plasma-sprayed unalloyed titanium coatings on metallic surgical implants. General requirements
  • BS ISO 23317, 2014 Edition, Implants for surgery. In vitro evaluation for apatite-forming ability of implant materials
  • ISO 11663, 2nd Edition, Quality of dialysis fluid for haemodialysis and related therapies
  • ISO 13179-1, 1st Edition, Implants for surgery - Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements
  • ISO 13958, 3rd Edition, Concentrates for haemodialysis and related therapies
  • ISO 13959, 3rd Edition, Water for haemodialysis and related therapies
  • ISO 17137, 1st Edition, Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
  • ISO 23317, 3rd Edition, Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials
  • ISO 23500, 2nd Edition, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
  • ISO 26722, 2nd Edition, Water treatment equipment for haemodialysis applications and related therapies
  • ISO 37137, 1st Edition, Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
  • SAE J3020, 2014 Edition, Medical Device Shot Peening



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