| 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/CD TS 37137-1.2 | Biological evaluation of medical devices — Part 1: Guidance for absorbable implants | ISO/TC 194/WG 15 | 2017-08-07 | 2020-01-31 | 30.20 |
| ISO/AWI 10993-17 | Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents | ISO/TC 194/WG 11 | 2018-06-06 | 2018-06-06 | 20.00 |
| ISO/CD TR 37137-2 | Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants — Part 2: Standard guide for absorbable metals | ISO/TC 194/WG 2 | 2016-03-11 | 2016-07-11 | 30.60 |
| ISO/CD TR 21582 | Pyrogenicity — Principle and method for pyrogen testing of medical devices | ISO/TC 194/WG 16 | 2016-03-11 | 2016-07-11 | 30.60 |
| ISO/FDIS 14155 | Clinical investigation of medical devices for human subjects — Good clinical practice | ISO/TC 194/WG 4 | 2016-06-17 | 2020-02-05 | 50.20 |
| ISO/DIS 10993-2 | Biological evaluation of medical devices — Part 2: Animal welfare requirements | ISO/TC 194/WG 3 | 2019-06-25 | 2020-02-13 | 40.20 |
| ISO/NP 10993-3 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive and developmental toxicity | ISO/TC 194/WG 6 | - | 2019-12-16 | 10.20 |
| ISO/DIS 10993-10 | Biological evaluation of medical devices — Part 10: Tests for skin sensitization | ISO/TC 194/WG 8 | 2018-04-16 | 2020-02-14 | 40.20 |
| ISO/DIS 10993-12 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials | ISO/TC 194/WG 12 | 2018-01-21 | 2019-08-01 | 40.60 |
| ISO/DIS 10993-23 | Biological evaluation of medical devices — Part 23: Tests for irritation | ISO/TC 194/WG 8 | 2018-01-18 | 2019-08-01 | 40.60 |
| ISO/AWI TR 10993-55 | Biological evaluation of medical devices — Part 55: Round Robin on cytotoxicity | ISO/TC 194/WG 6 | 2016-10-05 | 2016-10-05 | 10.99 |