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Standards Development
| Reference | Standards description | Committee | Status |
|---|---|---|---|
| BS EN ISO 11737-3 |
Sterilization of health care products - Microbiological methods. - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023) Categories: Microbiology. Medical | Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Public comment |
| BS EN ISO 11138-6 |
ISO 11138-6 Sterilization of health care products. Biological indicators. Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes Categories: Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Public comment |
| BS EN ISO 11135 |
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices Categories: Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Comment resolution |
| BS EN ISO 11737-1 |
Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products Categories: Microbiology. Medical | Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Public comment |
| BS EN ISO 13408-2:2018/A1 |
Aseptic processing of health care products —. Part 2: Sterilizing filtration — Amendment 1 Categories: Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Comment resolution |
| BS EN ISO 11137-1:2025 |
Sterilization of health care products. Radiation. Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Categories: Sterilization and disinfection. General | Sterilization and disinfection. Other |
CH/198 Sterilization and Associated Equipment and Processes | Approval |
| PD ISO/TS 17664-3 |
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices —. Part 3: Guidance on the designation of a reusable medical device to a cleaning classification Categories: Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Approval |
| BS EN 556-2:2024 |
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices Categories: Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Published standard |
| BS EN 556-1:2024 |
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices Categories: Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Published standard |
| BS EN ISO 13408-1:2024 |
Aseptic processing of health care products. General requirements Categories: Sterilization and disinfection. General |
CH/198 Sterilization and Associated Equipment and Processes | Published standard |