EN ISO 10993-6:2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

Standard No.
EN ISO 10993-6:2016
Release Date
2016
Published By
European Committee for Standardization (CEN)
Latest
EN ISO 10993-6:2016
Replace
FprEN ISO 10993-6:2016

EN ISO 10993-6:2016 Referenced Document

  • ASTM F1983-14 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications*2023-12-23 Update
  • ASTM F748-16 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices*2023-12-23 Update
  • ASTM F763-04 Standard Practice for Short-Term Screening of Implant Materials*2023-12-23 Update
  • ASTM F981-04 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone*2023-12-23 Update
  • ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
  • ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
  • ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
  • ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • ISO 11979-5:2006 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility
  • ISO 5832-1:2016 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
  • ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
  • ISO 5832-3:2016 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
  • ISO 5832-4:2014 Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
  • ISO 5832-5:2005 Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
  • ISO 5832-6:1997 Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
  • ISO 5832-7:1994 Implants for surgery; metallic materials; part 7: forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
  • ISO 5832-8:1997 Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy
  • ISO 5834-2:2011 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
  • ISO 6474-1:2010 Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumina
  • ISO 6474-2:2012 Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement
  • ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

EN ISO 10993-6:2016 history

  • 2016 EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • 2009 EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
  • 2007 EN ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation



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