NA 022
DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN ISO 14708-5 ; VDE 0750-20-5:2022-12 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 14708-1 | 2014-08 | Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer More |
| ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices More |
| ASTM F 1830 | 2019 | Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps More |
| ASTM F 1980 | 2021 | Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices More |
| DIN EN ISO 14155 | 2021-05 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020 More |
| DIN EN ISO 14971 | 2022-04 | Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More |
| DIN EN ISO 5198 | 1999-12 | Centrifugal, mixed flow and axial pumps - Code for hydraulic performance tests - Precision class (ISO 5198:1987); German version EN ISO 5198:1998 More |
| DIN EN ISO 7198 | 2017-07 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016); German version EN ISO 7198:2017 More |
| DIN EN 60068-1 ; VDE 0468-1:2015-09 | 2015-09 | Environmental testing - Part 1: General and guidance (IEC 60068-1:2013); German version EN 60068-1:2014 More |
| DIN EN 60068-2-27 ; VDE 0468-2-27:2010-02 | 2010-02 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock (IEC 60068-2-27:2008); German version EN 60068-2-27:2009 More |
