I.S. EN ISO 10993-6:2016
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
Hardcopy , PDF
English
01-01-2016
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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 |
| Standards | Relationship |
| NS EN ISO 10993-6 : 2016 | Identical |
| NEN EN ISO 10993-6 : 2016 | Identical |
| NF EN ISO 10993-6 : 2017 | Identical |
| EN ISO 10993-6:2016 | Identical |
| NBN EN ISO 10993-6 : 2009 | Identical |
| ISO 10993-6:2016 | Identical |
| DIN EN ISO 10993-6:2009-08 | Identical |
| SN EN ISO 10993-6 : 2017 | Identical |
| UNE-EN ISO 10993-6:2017 | Identical |
| UNI EN ISO 10993-6 : 2009 | Identical |
| BS EN ISO 10993-6:2016 | Identical |
| DIN EN ISO 10993-6:2017-09 | Identical |
| 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 |
| 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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