DIN EN ISO 13485 [Withdrawn] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
| DIN EN ISO 10012 | 2004-03 | Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003 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 |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| ISO 10012 | 2003-04 | Measurement management systems - Requirements for measurement processes and measuring equipment More |
| ISO 14644-1 | 2015-12 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration 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 14644-5 | 2004-08 | Cleanrooms and associated controlled environments - Part 5: Operations More |
| ISO 14644-7 | 2004-10 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) More |
