Items to be displayed:
| Subcommittee | Subcommittee Title |
|---|---|
| ISO/TC 194/SC 1 | Tissue product safety |
| Standard and/or project | Stage | ICS |
|---|---|---|
| ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | 60.60 | 11.100.20 |
| ISO 10993-1:2009/Cor 1:2010 | 60.60 | 11.100.20 |
| ISO 10993-2:2006 Biological evaluation of medical devices -- Part 2: Animal welfare requirements | 90.60 | 11.100.20 |
| ISO 10993-3:2003 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | 90.92 | 11.100.20 |
| ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood | 90.92 | 11.100.20 |
| ISO 10993-4:2002/Amd 1:2006 | 60.60 | 11.100.20 |
| ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | 90.92 | 11.100.20 |
| ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | 90.92 | 11.100.20 |
| ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals | 90.60 | 11.100.20 |
| ISO 10993-7:2008/Cor 1:2009 | 60.60 | 11.100.20 |
| ISO 10993-9:2009 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products | 60.60 | 11.100.20 |
| ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | 60.60 | 11.100.20 |
| ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | 90.60 | 11.100.20 |
| ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | 60.60 | 11.100.20 |
| ISO 10993-13:2010 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices | 60.60 | 11.100.20 |
| ISO 10993-14:2001 Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics | 90.60 | 11.100.20 |
| ISO 10993-15:2000 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | 90.60 | 11.100.20 |
| ISO 10993-16:2010 Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables | 60.60 | 11.100.20 |
| ISO 10993-17:2002 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances | 90.20 | 11.100.20 |
| ISO 10993-18:2005 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials | 90.60 | 11.100.20 |
| ISO/TS 10993-19:2006 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials | 90.60 | 11.100.20 |
| ISO/TS 10993-20:2006 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices | 90.60 | 11.100.20 |
| ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice | 60.60 | 11.100.20 |
| ISO 14155:2011/Cor 1:2011 | 60.60 | 11.100.20 |
| ISO/TR 15499:2012 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process | 60.60 | 11.100.20 |
