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ANSI/AAMI/ISO 10993-6:2016

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-10-2017

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
 ISO 10993-6:2016
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Common provisions for implantation
  test methods
5 Test methods, general aspects
6 Test report
Annex A (normative) - Test methods for
        implantation in subcutaneous
        tissue
Annex B (normative) - Test method for
        implantation in muscle
Annex C (normative) - Test method for
        implantation in bone
Annex D (normative) - Test method for
        implantation in brain tissue
Annex E (informative) - Examples of
        evaluation of local biological
        effects after implantation
Bibliography

Describes test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.

DocumentType
Standard
ISBN
978-1-57020-668-9
Pages
41
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 10993-6:2016 Identical

AAMI TIR17 : 2017 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI TIR14 : 2016 CONTRACT STERILIZATION USING ETHYLENE OXIDE

ISO 5832-1:2016 Implants for surgery Metallic materials Part 1: Wrought stainless steel
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
ASTM F 1983 : 2014 : REDLINE Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ISO 5832-6:1997 Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
ISO 5832-5:2005 Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
ISO 5832-3:2016 Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 5832-8:1997 Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
ISO 5832-4:2014 Implants for surgery Metallic materials Part 4: Cobalt-chromium-molybdenum casting alloy
ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
ISO 10993-11:2017 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 5834-2:2011 Implants for surgery Ultra-high-molecular-weight polyethylene Part 2: Moulded forms
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 5832-2:1999 Implants for surgery Metallic materials Part 2: Unalloyed titanium
ISO 5832-7:2016 Implants for surgery Metallic materials Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
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 6474-2:2012 Implants for surgery Ceramic materials Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

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