NA 027
DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 22442-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11737-1 AMD 1 | 2021-05 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products; Amendment 1 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 13408-2 | 2018-01 | Aseptic processing of health care products - Part 2: Sterilizing filtration More |
| ISO 13408-3 | 2006-09 | Aseptic processing of health care products - Part 3: Lyophilization More |
| ISO 13408-4 | 2005-11 | Aseptic processing of health care products - Part 4: Clean-in-place technologies More |
| ISO 13408-5 | 2006-11 | Aseptic processing of health care products - Part 5: Sterilization in place More |
| ISO 13408-6 | 2021-04 | Aseptic processing of health care products - Part 6: Isolator systems More |
| ISO 13408-7 | 2012-08 | Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14160 | 2020-09 | 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 More |
