| 文書番号 | 文書名 | 担当 | 新規登録日 | 現状登録日 | Stage現状 （ISO HPを参照） |
| ISO 10993-18:2020/NP Amd 1 | Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor | ISO/TC 194/WG 14 | - | 2021/3/2 | 10.60 |
| ISO/CD 10993-17.2 | Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents | ISO/TC 194/WG 11 | 2018/6/6 | 2021/1/21 | 30.60 |
| ISO/DIS 10993-2 | Biological evaluation of medical devices — Part 2: Animal welfare requirements | ISO/TC 194/WG 3 | 2019/6/25 | 2020/5/8 | 40.60 |
| ISO/CD TR 37137-2 | Biological evaluation of absorbable medical devices — Part 2: Standard guide for absorbable metals | ISO/TC 194/WG 2 | 2016/3/11 | 2016/7/11 | 30.60 |
| ISO/PRF TR 21582 | Pyrogenicity — Principle and method for pyrogen testing of medical devices | ISO/TC 194/WG 16 | 2016/3/11 | 2021/3/29 | 50.00 |
| ISO/CD 10993-3 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive and developmental toxicity | ISO/TC 194/WG 6 | 2020/3/6 | 2020/3/6 | 30.99 |
| ISO/FDIS 10993-10 | Biological evaluation of medical devices — Part 10: Tests for skin sensitization | ISO/TC 194/WG 8 | 2018/4/16 | 2021/1/25 | 50.00 |
| ISO/AWI TR 10993-55 | Biological evaluation of medical devices — Part 55: Round Robin on cytotoxicity | ISO/TC 194/WG 6 | 2016/10/5 | 2016/10/5 | 10.99 |