| 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 22441.2 | Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | ISO/TC 198/WG 16 | 2017/8/16 | 2021/1/22 | 30.60 |
| ISO/CD 13408-1 | Aseptic processing of health care products — Part 1: General requirements | ISO/TC 198/WG 9 | 2018/10/23 | 2021/3/11 | 30.60 |
| ISO/CD 11140-6.2 | Sterilization of health care products — Chemical indicators — Part 6: Class 2 indicators and process challenge devices for use in performance testing of steam sterilizers | ISO/TC 198/WG 6 | 2015/8/10 | 2020/4/5 | 30.60 |
| ISO 11138-5:2017/AWI Amd 1 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes — Amendment 1: Annex C: Alternative method for determining the D-value of LTSF SCBI | ISO/TC 198/WG 4 | 2017/6/6 | 2017/6/6 | 10.99 |
| ISO/CD 13004 | Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD | ISO/TC 198/WG 2 | 2020/12/14 | 2020/12/14 | 30.99 |
| ISO/DIS 15883-1 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests | ISO/TC 198/WG 13 | 2019/12/6 | 2021/2/27 | 40.60 |
| ISO/DIS 11138-8 | Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator | ISO/TC 198/WG 4 | 2015/8/10 | 2020/12/29 | 40.60 |
| ISO/AWI TS 5111 | Quality of water for sterilizers, sterilization and washer-disinfectors | ISO/TC 198 | 2020/9/15 | 2020/9/15 | 20.00 |
| ISO 25424:2018/DAmd 1 | Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1 | ISO/TC 198 | 2020/6/2 | 2021/3/30 | 40.20 |
| ISO 18362:2016/DAmd 1 | Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1 | ISO/TC 198/WG 9 | 2020/6/2 | 2021/3/16 | 40.20 |
| ISO/CD 17665 | Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices | ISO/TC 198/WG 3 | 2019/12/16 | 2021/3/3 | 30.60 |
| ISO/FDIS 17664-1 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices | ISO/TC 198/WG 12 | 2020/9/8 | 2021/2/25 | 50.20 |
| ISO/PRF TS 16775 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 | ISO/TC 198/WG 7 | 2018/6/27 | 2021/2/15 | 50.00 |
| ISO/FDIS 15883-5 | Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy | ISO/TC 198/WG 13 | 2015/8/11 | 2021/1/28 | 50.60 |
| ISO 13408-6 | Aseptic processing of health care products — Part 6: Isolator systems | ISO/TC 198/WG 9 | 2017/5/15 | 2020/8/24 | 60.00 |
| ISO 11737-1:2018/FDAmd 1 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1 | ISO/TC 198/WG 8 | 2018/9/11 | 2020/8/28 | 50.60 |
| ISO/CD 11737-3 | Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing | ISO/TC 198/WG 8 | 2018/11/6 | 2019/12/11 | 30.00 |
| ISO 11607-1:2019/CD Amd 1 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1 | ISO/TC 198/WG 7 | 2020/6/2 | 2020/12/10 | 30.00 |
| ISO 11607-2:2019/CD Amd 1 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1 | ISO/TC 198/WG 7 | 2019/12/6 | 2019/12/6 | 30.99 |
| ISO/AWI 11138-6 | Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes | ISO/TC 198/WG 4 | 2017/11/29 | 2017/11/29 | 20.00 |
| ISO/AWI 11137-1 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | ISO/TC 198/WG 2 | 2020/9/8 | 2020/9/8 | 10.99 |
| ISO 11137-2:2013/DAmd 1 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1 | ISO/TC 198/WG 2 | 2020/9/15 | 2021/2/1 | 40.20 |
| ISO/AWI 11135 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | ISO/TC 198/WG 1 | 2020/7/22 | 2020/7/22 | 10.99 |