Wednesday, January 21, 2015

New Implants For Surgery, Prosthetics And Orthotics Standards for the 4th Quarter 2014

Document Center Inc. is pleased to announce that the following New Standards on Implants For Surgery, Prosthetics And Orthotics are now available:
  • ANSI/AAMI/ISO 5841-2, 2014 Edition, Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads
  • ANSI/AAMI/ISO 11663, 2014 Edition, Quality of dialysis fluid for hemodialysis and related therapies
  • ANSI/AAMI/ISO 13958, 2014 Edition, Concentrates for hemodialysis and related therapies
  • ANSI/AAMI/ISO 13959, 2014 Edition, Water for hemodialysis and related therapies
  • ANSI/AAMI/ISO 23500, 2014 Edition, Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
  • ANSI/AAMI/ISO 26722, 2014 Edition, Water treatment equipment for hemodialysis applications and related therapies
  • ASTM F452, 1976 Edition Reapproved in 2014, Standard Specification for Preformed Cranioplasty Plates
  • ASTM F602, 2009 Edition Reapproved in 2014, Standard Criteria for Implantable Thermoset Epoxy Plastics
  • ASTM F641, 2009 Edition Reapproved in 2014, Standard Specification for Implantable Epoxy Electronic Encapsulants
  • ASTM F647, 1994 Edition Reapproved in 2014, Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
  • ASTM F688, 2014 Edition, Standard Specification for Wrought Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)
  • ASTM F746, 2004 Edition Reapproved in 2014, Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
  • ASTM F881, 1994 Edition Reapproved in 2014, Standard Specification for Silicone Elastomer Facial Implants
  • ASTM F961, 2014 Edition, Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
  • ASTM F1801, 1997 Edition Reapproved in 2014, Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials
  • ASTM F1828, 1997 Edition Reapproved in 2014, Standard Specification for Ureteral Stents
  • ASTM F1831, 1997 Edition Reapproved in 2014, Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices
  • ASTM F1875, 1998 Edition Reapproved in 2014, Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
  • ASTM F2051, 2000 Edition Reapproved in 2014, Standard Specification for Implantable Saline Filled Breast Prosthesis
  • ASTM F2193, 2014 Edition, Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
  • ASTM F2706, 2008 Edition Reapproved in 2014, Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
  • ASTM F2790, 2010 Edition Reapproved in 2014, Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
  • BS ISO 8549-4, 2014 Edition, Prosthetics and orthotics. Vocabulary. Terms relating to limb amputation
  • BS ISO 8828, 2014 Edition, Implants for surgery. Guidance on care and handling of orthopaedic implants
  • BS ISO 14242-1, 2014 Edition, Implants for surgery. Wear of total hip-joint prostheses. Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
  • BS ISO 14243-3, 2014 Edition, Implants for surgery. Wear of total knee-joint prostheses. Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
  • ISO 8549-4, 1st Edition, Prosthetics and orthotics - Vocabulary - Part 4: Terms relating to limb amputation
  • ISO 8828, 2nd Edition, Implants for surgery - Guidance on care and handling of orthopaedic implants
  • ISO 14242-1, 3rd Edition, Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
  • ISO 14243-3, 2nd Edition, Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test



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