| 文書番号 | 文書名 | 担当 | 発行日 | Stage現状 （ISO HPを参照） |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process | ISO/TC 194/WG 1 | 2018/8/17 | 60.60 |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements | ISO/TC 194/WG 3 | 2019/6/25 | 90.92 |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | ISO/TC 194/WG 6 | 2019/12/16 | 90.92 |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood | ISO/TC 194/WG 9 | 2017/4/12 | 60.60 |
| ISO 10993-5:2009 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | ISO/TC 194/WG 5 | 2017/2/9 | 90.93 |
| ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation | ISO/TC 194/WG 10 | 2016/11/28 | 60.60 |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals | ISO/TC 194/WG 11 | 2016/11/28 | 90.93 |
| ISO 10993-7:2008/Amd 1:2019 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants | ISO/TC 194/WG 11 | 2019/12/9 | 60.60 |
| ISO 10993-7:2008/Cor 1:2009 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1 | ISO/TC 194/WG 11 | 2009/11/12 | 60.60 |
| ISO 10993-9:2019 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products | ISO/TC 194/WG 2 | 2019/11/26 | 60.60 |
| ISO 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization | ISO/TC 194/WG 8 | 2018/1/12 | 90.92 |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | ISO/TC 194/WG 7 | 2017/9/14 | 60.60 |
| ISO 10993-12:2021 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | ISO/TC 194/WG 12 | 2021/1/20 | 60.60 |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices | ISO/TC 194/WG 2 | 2019/5/2 | 90.93 |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics | ISO/TC 194/WG 2 | 2019/5/2 | 90.93 |
| ISO 10993-15:2019 | Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys | ISO/TC 194/WG 2 | 2019/11/26 | 60.60 |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables | ISO/TC 194/WG 13 | 2017/5/16 | 60.60 |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances | ISO/TC 194/WG 11 | 2018/1/19 | 90.92 |
| ISO 10993-18:2020 | Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process | ISO/TC 194/WG 14 | 2020/1/13 | 60.60 |
| ISO/TS 10993-19:2020 | Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials | ISO/TC 194/WG 14 | 2020/3/12 | 60.60 |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices | ISO/TC 194/WG 7 | 2014/10/10 | 90.93 |
| ISO/TR 10993-22:2017 | Biological evaluation of medical devices — Part 22: Guidance on nanomaterials | ISO/TC 194/WG 17 | 2017/7/14 | 60.60 |
| ISO 10993-23:2021 | Biological evaluation of medical devices — Part 23: Tests for irritation | ISO/TC 194/WG 8 | 2021/1/20 | 60.60 |
| ISO/TR 10993-33:2015 | Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3 | ISO/TC 194/WG 6 | 2015/3/6 | 60.60 |
| ISO 13022:2012 | Medical products containing viable human cells — Application of risk management and requirements for processing practices | ISO/TC 194 | 2017/6/7 | 90.93 |
| ISO 14155:2020 | Clinical investigation of medical devices for human subjects — Good clinical practice | ISO/TC 194/WG 4 | 2020/7/28 | 60.60 |
| ISO/TS 21726:2019 | Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents | ISO/TC 194/WG 11 | 2019/2/1 | 60.60 |
| ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management | ISO/TC 194 | 2020/9/15 | 60.60 |
| ISO 22442-2:2020 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling | ISO/TC 194 | 2020/9/15 | 60.60 |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents | ISO/TC 194 | 2015/9/17 | 90.93 |
| ISO/TR 22442-4:2010 | Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes | ISO/TC 194 | 2016/4/22 | 90.93 |
| ISO/TR 37137:2014 | Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants | ISO/TC 194 | 2016/4/7 | 90.92 |
| ISO/TS 37137-1:2021 | Biological evaluation of absorbable medical devices — Part 1: General requirements | ISO/TC 194/WG 2 | 2021/3/12 | 60.60 |