| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 21.03.2014 12:31:24 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.3.2 Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS, 5.4 PRIMARY OPERATING FUNCTIONS, 5.5 USABILITY SPECIFICATION, 5.6 USABILITY VALIDATION plan, Create USI, 4.2 Intended use and identification of characteristics related to the safety of the medical device |