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New Implants For Surgery, Prosthetics, And Orthotics Standards for the 3rd Quarter 2016

Kyle Bach

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


  • ASTM F1634, 1995 Edition Reapproved in 2016, Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
  • ASTM F2777, 2016 Edition, Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
  • BS EN ISO 10328, 2016 Edition, Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods
  • BS EN ISO 22675, 2016 Edition, Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
  • BS ISO 5832-1, 2016 Edition, Implants for surgery. Metallic materials. Wrought stainless steel
  • BS ISO 7206-12, 2016 Edition, Implants for surgery. Partial and total hip joint prostheses. Deformation test method for acetabular shells
  • BS ISO 7206-13, 2016 Edition, Implants for surgery. Partial and total hip joint prostheses. Determination of resistance to torque of head fixation of stemmed femoral components
  • BS ISO 7207-2, 2011 Edition with Amendment 1, Implants for surgery. Components for partial and total knee joint prostheses. Articulating surfaces made of metal, ceramic and plastics materials
  • BS ISO 14242-2, 2016 Edition, Implants for surgery. Wear of total hip-joint prostheses. Methods of measurement
  • BS ISO 14243-2, 2016 Edition, Implants for surgery. Wear of total knee-joint prostheses. Methods of measurement
  • BS ISO 15674, 2016 Edition, Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
  • BS ISO 15675, 2016 Edition, Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters
  • BS ISO 15676, 2016 Edition, Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
  • BS ISO 18241, 2016 Edition, Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps
  • BS ISO 18242, 2016 Edition, Cardiovascular implants and extracorporeal systems. Centrifugal blood pumps
  • ISO 5832-1, 5th Edition, Implants for surgery – Metallic materials – Part 1: Wrought stainless steel
  • ISO 7198, 2nd Edition, Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches
  • ISO 7206-2, Amendment 1 for the 3rd Edition, Implants for Surgery – Partial and Total Hip Joint Prostheses – Part 2: Articulating Surfaces Made of Metallic, Ceramic and Plastics Materials
  • ISO 7206-12, 1st Edition, Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells
  • ISO 7206-13, 1st Edition, Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
  • ISO 7207-2, Amendment 1 for the 2nd Edition, Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials
  • ISO 14242-2, 2nd Edition, Implants for surgery – Wear of total hip-joint prostheses – Part 2: Methods of measurement
  • ISO 14243-2, 3rd Edition, Implants for surgery – Wear of total knee-joint prostheses – Part 2: Methods of measurement
  • ISO 15674, 3rd Edition, Cardiovascular implants and artificial organs – Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
  • ISO 15675, 3rd Edition, Cardiovascular implants and artificial organs – Cardiopulmonary bypass systems – Arterial blood line filters
  • ISO 15676, 2nd Edition, Cardiovascular implants and artificial organs – Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
  • ISO 18241, 1st Edition, Cardiovascular implants and extracorporeal systems – Cardiopulmonary bypass systems – Venous bubble traps
  • ISO 18242, 1st Edition, Cardiovascular implants and extracorporeal systems – Centrifugal blood pumps
  • ISO 19024, 1st Edition, Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass