NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11139 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 11140-1 | 2015-03 | Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014 More |
| DIN EN ISO 11140-4 | 2007-07 | Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (ISO 11140-4:2007); German version EN ISO 11140-4:2007 More |
| DIN EN ISO 11607-1 | 2024-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023 More |
| DIN EN ISO 11607-2 | 2024-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019 + Amd 1:2023); German version EN ISO 11607-2:2020 + A1:2023 More |
| DIN EN ISO 11737-1 | 2021-10 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021 More |
| DIN EN ISO 11737-2 | 2020-07 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019); German version EN ISO 11737-2:2020 More |
| DIN EN ISO 13004 | 2023-10 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO 13004:2022); German version EN ISO 13004:2023 More |
| DIN EN ISO 13408-2 | 2018-06 | Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018); German version EN ISO 13408-2:2018 More |
| DIN EN ISO 13408-3 | 2011-09 | Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006); German version EN ISO 13408-3:2011 More |
| DIN EN ISO 13408-4 | 2011-09 | Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005); German version EN ISO 13408-4:2011 More |
