Sterilization - Related International Standards
The following non-harmonised international standards are related to Sterilization for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 11737-1:2018/Amd 1:2021 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products | active | 11, 11.3 | Link |
| ISO 11135:2014+AMD1:2018 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | active | 11, 11.1, 11.5, 11.6 | Link |
| ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements | active | 11 | Link |
| ISO 11138-2:2017 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes | active | 11 | Link |
| ISO 11139:2018/Amd 1:2024 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards | active | 11 | Link |
| 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 | active | 11, 11.1 | Link |
| ISO 11137-2:2013+AMD1:2022 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | active | 11, 11.1 | Link |
| ISO 17665:2024 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices | active | 11, 11.1 | Link |
| ISO 11737-2:2019 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | active | 11, 11.3 | Link |
| ISO 13408-1:2024 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) | active | 11, 11.5, 11.6 | Link |
| ISO 13408-6:2021 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) | active | 11, 11.5, 11.6 | Link |
| ISO 14160:2021 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives (ISO 14160:2020) | active | 11, 11.5, 11.6, 13 | Link |
| ISO 25424:2019 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) | active | 11, 11.5 | Link |