NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13485 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 11607-2 | 2019-02 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes More |
| ISO 14644-1 | 2015-12 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration More |
| ISO 14644-12 | 2018-08 | Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration More |
| ISO 14644-16 | 2019-05 | Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices More |
| ISO 14644-17 | 2021-02 | Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications More |
| ISO 14644-2 | 2015-12 | Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration More |
| ISO 14644-3 | 2019-08 | Cleanrooms and associated controlled environments - Part 3: Test methods 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 9001 | 2015-09 | Quality management systems - Requirements More |
