NA 176
DIN Standards Committee Health Technologies
DIN EN 556-2 [New] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 22441 | 2022-08 | Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More |
| DIN EN ISO 13408-7 | 2015-11 | Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015 More |
| DIN EN ISO 9000 | 2015-11 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More |
| EN ISO 11137-2 | 2015-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) More |
| EN ISO 11137-3 | 2017-07 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017) More |
| EN ISO 11139 | 2018-09 | Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018) More |
| EN ISO 11737-1 | 2018-01 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) More |
| EN ISO 11737-2 | 2020-05 | 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) More |
| EN ISO 13004 | 2023-06 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDₘₐₓSD (ISO 13004:2022) More |
| EN ISO 13408-1 | 2024-04 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) More |
