Sterilization
11 standards in this category.
| Standard | Title | Scope | GSPR |
|---|---|---|---|
| EN 556-1:2001 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices | Requirements for terminally sterilized device labelling | 11, 11.3, 23 |
| ISO 11737-1:2018 | Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products | Bioburden testing methods | 11, 11.3 |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | EO sterilization validation | 11, 11.5, 11.6 |
| ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements | Sterilization of health care products -- Biological indicators -- General requir... | 11 |
| ISO 11138-2:2017 | Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes | Sterilization of health care products -- Biological indicators -- Biological ind... | 11 |
| ISO 11139:2018 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards | Sterilization of health care products -- Vocabulary of terms used in sterilizati... | 11 |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Sterilization of health care products -- Moist heat -- Requirements for the deve... | 11, 11.2, 11.5, 11.6 |
| ISO 11135:2014+AMD1:2019 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices | Ethylene oxide sterilization of medical devices. | 11, 11.1 |
| ISO 11137-1:2006+AMD2:2019 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Radiation sterilization of medical devices. | 11, 11.1 |
| ISO 11137-2:2013+AMD1:2022 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | Establishing radiation sterilization dose. | 11, 11.1 |
| ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Moist heat sterilization of medical devices. | 11, 11.1 |