NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 14971 [Withdrawn] references following documents: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 ISO 31000 | 2018-10 | Risk management - Guidelines (ISO 31000:2018) More |
| DIN 820-12 | 2014-06 | Standardization - Part 12: Guidelines for the inclusion of safety aspects in standards (ISO/IEC Guide 51:2014) 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 |
| IEC 60601-1 | 2005-12 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices More |
| 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 20916 | 2019-05 | In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice More |
