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I.S. EN 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 (ISO 10993-6:2016)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
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
Annex ZA (informative) - Relationship between this
         European Standard and the essential
         requirements of Directive 93/42/EEC
         [OJ L 169] aimed to be covered
Annex ZB (informative) - Relationship between this
         European Standard and the essential
         requirements of Directive 90/385/EEC
         [OJ L 189] aimed to be covered

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

DevelopmentNote
Supersedes I.S. EN 30993-6. (10/2007)
DocumentType
Standard
Pages
50
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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
EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
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
EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
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
EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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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