NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 14971 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC/TR3 60513 | 1994-01 | Fundamental aspects of safety standards for medical electrical equipment More |
| ISO 10993-1 | 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 14155 | 2020-07 | Clinical investigation of medical devices for human subjects - Good clinical practice More |
| ISO 20916 | 2019-05 | In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice More |
| ISO 31000 | 2018-02 | Risk management - Guidelines More |
| ISO 9000 | 2015-09 | Quality management systems - Fundamentals and vocabulary More |
| ISO/IEC Guide 51 | 2014-04 | Safety aspects - Guidelines for their inclusion in standards More |
| ISO/IEC Guide 63 | 2019-08 | Guide to the development and inclusion of aspects of safety in International Standards for medical devices More |
| ISO/TR 24971 | 2020-06 | Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020) More |
