NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 11139 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11138-7 | 2019-03 | Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results More |
| ISO 11138-8 | 2021-07 | Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator More |
| ISO 11140-1 | 2014-11 | Sterilization of health care products - Chemical indicators - Part 1: General requirements More |
| ISO 11140-4 | 2007-03 | 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 More |
| ISO 11140-5 | 2007-03 | Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests More |
| ISO 11607-1 | 2019-02 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems More |
| ISO 11607-2 | 2019-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes More |
| ISO 11737-1 | 2018-01 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products More |
| ISO 11737-2 | 2019-12 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process More |
| ISO 11737-3 | 2023-06 | Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing More |
