NA 176
DIN Standards Committee Health Technologies
DIN EN 556-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| EN ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) More |
| EN ISO 11135 | 2014-07 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) More |
| EN ISO 11137-1 | 2015-06 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) 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 14160 | 2021-06 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) More |
