Home » Compliance Management Blog- ESG, EHS, EHSQ » New Implants for Surgery, Prosthetics, and Orthotics Standards for the 2nd Quarter 2016

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


  • AAMI/ISO TIR-12417, 2011 Edition Reprint (ANSI Designation Dropped), Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products
  • AAMI/ISO TIR37137, 2014 Edition Reprint (ANSI Designation Dropped), Cardiovascular biological evaluation of medical devices – Guidance for absorbable implants
  • ANSI/AAMI/ISO 5840-1, 2015 Edition, Cardiovascular implants-Cardiac valve prostheses – Part 1: General requirements
  • ANSI/AAMI/ISO 5840-2, 2015 Edition, Cardiovascular implants-Cardiac valve prostheses – Part 2: Surgically implanted heart valve substitutes
  • ASTM F629, 2015 Edition, Standard Practice for Radiography of Cast Metallic Surgical Implants
  • ASTM F703, Withdrawn Without Replacement, Standard Specification for Implantable Breast Prostheses
  • ASTM F981, 2004 Edition Reapproved in 2016, Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone
  • ASTM F1264, 2016 Edition, Standard Specification and Test Methods for Intramedullary Fixation Devices
  • ASTM F1814, 2015 Edition, Standard Guide for Evaluating Modular Hip and Knee Joint Components
  • ASTM F1829, 2016 Edition, Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
  • ASTM F2065, Withdrawn Without Replacement, Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
  • ASTM F2385, 2015 Edition, Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
  • ASTM F2527, 2016 Edition, Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537)
  • ASTM F3129, 2016 Edition, Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
  • BS EN ISO 13959, Corrigendum 1 for the 2015 Edition, Water for haemodialysis and related therapies
  • BS ISO 7206-4, 2010 Edition with Amendment 1, Implants for surgery. Partial and total hip joint prostheses. Determination of endurance properties and performance of stemmed femoral components
  • BS ISO 29783-3, 2016 Edition, Prosthetics and orthotics. Vocabulary. Pathological gait (excluding prosthetic gait)
  • DIN EN ISO 5480, Withdrawn and Replaced by DIN EN ISO 5840-2, Cardiovascular implants – Cardiac valve prostheses
  • ISO 7206-4-AM1, Amendment to the 3rd Edition, AMENDMENT 1, Part 4: Determination of endurance properties and performance of stemmed femoral components, Implants for surgery – Partial and total hip joint prostheses
  • ISO 10328, 2nd Edition, Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods
  • ISO 16955, 1st Edition, Prosthetics – Quantification of physical parameters of ankle foot devices and foot units
  • ISO 22675, 2nd Edition, Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods
  • ISO 29783-3, 1st Edition, Prosthetics and orthotics – Vocabulary – Part 3: Pathological gait (excluding prosthetic gait)
  • PD ISO 16955, 2016 Edition, Prosthetics. Quantification of physical parameters of ankle foot devices and foot units