NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13408-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 13408-7 | 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 |
| ISO 14644-3 | 2019-08 | Cleanrooms and associated controlled environments - Part 3: Test methods More |
| ISO 14698-1 | 2003-09 | Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods More |
| ISO 14698-2 | 2003-09 | Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data More |
| ISO 14937 | 2009-10 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices More |
