NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 22367 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 60812 | 2006-11 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) (IEC 60812:2006); German version EN 60812:2006 More |
| DIN EN 61025 | 2007-08 | Fault tree analysis (FTA) (IEC 61025:2006); German version EN 61025:2007 More |
| IEC 60601-1 | 2005-12 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More |
| IEC 61025 | 2006-12 | Fault tree analysis (FTA) More |
| 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 |
