DIN EN ISO 13408-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11137-1 | 2006-04 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More |
| ISO 11137-2 | 2013-06 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose 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 14644-5 | 2004-08 | Cleanrooms and associated controlled environments - Part 5: Operations More |
| ISO 14644-7 | 2004-10 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) 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 |
