NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 13485 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 14644-5 | 2005-03 | Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004); German version EN ISO 14644-5:2004 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 19011 | 2018-10 | Guidelines for auditing management systems (ISO 19011:2018); German and English version EN ISO 19011:2018 More |
| DIN EN ISO 9000 | 2015-11 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 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 |
| 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 |
