NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13485 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| 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 14644-15 | 2017-10 | Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical 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 |
