NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 22367 [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 |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ISO 20916 | 2019-05 | In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
| ISO/IEC Guide 99 | 2007-12 | International vocabulary of metrology - Basic and general concepts and associated terms (VIM) More |
| ISO/TR 24971 | 2020-06 | Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) More |
