NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13485 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 14644-1 | 2016-06 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015); German version EN ISO 14644-1:2015 More |
| DIN EN ISO 14644-16 | 2020-06 | Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019); German version EN ISO 14644-16:2019 More |
| DIN EN ISO 14644-17 | 2021-06 | Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021); German version EN ISO 14644-17:2021 More |
| DIN EN ISO 14644-2 | 2016-05 | Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015); German version EN ISO 14644-2:2015 More |
| DIN EN ISO 14644-3 | 2020-08 | Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06); German version EN ISO 14644-3:2019 More |
| DIN EN ISO 14644-7 | 2005-01 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004 More |
| DIN EN ISO 9001 | 2015-11 | Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More |
| DIN EN 17141 | 2021-02 | Cleanrooms and associated controlled environments - Biocontamination control; German version EN 17141:2020 More |
| DIN EN 62366-1 ; VDE 0750-241-1:2021-08 | 2021-08 | Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020 More |
| EN ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) More |
