Wednesday, February 3, 2016

New Implants For Surgery, Prosthetics And Orthotics Standards for the 4th Quarter 2015

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


  • ASTM F620, 2011 Edition Reapproved in 2015, Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
  • ASTM F1781, 2015 Edition, Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
  • ASTM F2180, 2002 Edition Reapproved in 2015, Standard Specification for Metallic Implantable Strands and Cables
  • BS EN ISO 5840, Withdrawn and replaced by BS EN ISO 5840-2, Cardiovascular implants. Cardiac valve prostheses
  • BS EN ISO 5840-1, 2015 Edition, Cardiovascular implants. Cardiac valve prostheses. General requirements
  • BS EN ISO 5840-2, 2015 Edition, Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes
  • BS EN ISO 12417-1, 2015 Edition, Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. General requirements
  • BS EN ISO 13356, 2015 Edition, Implants for surgery. Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
  • BS EN ISO 13958, 2015 Edition, Concentrates for haemodialysis and related therapies
  • BS EN ISO 23500,  Corrigendum 1 for 2014 Edition, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
  • BS EN ISO 26722, Corrigendum 1 for 2014 Edition, Water treatment equipment for haemodialysis applications and related therapies
  • ISO 12417-1, 1st Edition, Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements



You can also take a look at my previous post: