14/30261590 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
Hardcopy , PDF
English
31-12-2016
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 central
nervous system (neural) tissue
Annex E (normative) - Examples of evaluation of local biological
effects after implantation
Bibliography
BS EN ISO 10993-6.
| Committee |
CH/194
|
| DocumentType |
Draft
|
| Pages |
38
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 5832-1:2016 | Implants for surgery — Metallic materials — Part 1: Wrought stainless steel |
| 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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