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I.S. EN ISO 10993-6:2016

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

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


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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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