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

Standard No.

BS EN ISO 10993-6:2016

Release Date

2016

Published By

British Standards Institution (BSI)

Latest

BS EN ISO 10993-6:2016

Replace

BS EN ISO 10993-6:2009

BS EN ISO 10993-6:2016 Referenced Document

• 90/385/EEC COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
• 93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
• ASTM F1983 Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ASTM F763 Standard Practice for Short-Term Screening of Implant Materials
• ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
• EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
• EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
• EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
• EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
• EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
• 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 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
• ISO 11979-5 Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility*， 2020-09-24 Update
• ISO 5832-1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
• ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium*， 2018-03-01 Update
• ISO 5832-3 Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy*， 2021-11-18 Update
• ISO 5832-4 Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
• ISO 5832-5 Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel*， 2022-03-18 Update
• ISO 5832-6 Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy*， 2022-03-21 Update
• ISO 5832-7 Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
• ISO 5832-8 Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy
• ISO 5834-2 Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms*， 2019-02-12 Update
• ISO 6474-1 Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina*， 2019-03-13 Update
• ISO 6474-2 Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement*， 2019-03-13 Update
• ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry*， 2018-10-01 Update

BS EN ISO 10993-6:2016 history

• 2016 BS EN ISO 10993-6:2016 Biological evaluation of medical devices. Tests for local effects after implantation
• 2009 BS EN ISO 10993-6:2009 Biological evaluation of medical devices. Tests for local effects after implantation
• 0000 BS EN ISO 10993-6:2007