NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13485 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 |
| EN ISO 13485/AC | 2018-03 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) More |
| EUV 2017/745 | 2017-04-05 | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More |
| EUV 2017/746 | 2017-04-05 | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More |
| 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 |
