| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 01.04.2014 11:00:02 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 3 Terms and definitions |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- IEC 62366 Usability
- 3 Terms and definitions
3 Terms and definitions
3.1 ABNORMAL USE- 3.2 ACCOMPANYING DOCUMENT
- 3.3 ALARM LIMIT
- 3.4 ALARM OFF
- 3.5 ALARM SIGNAL
- 3.6 ALARM SYSTEM
- 3.7 CORRECT USE
- 3.8 EFFECTIVENESS
- 3.9 EFFICIENCY
- 3.10 INFORMATION SIGNAL
- 3.11 MEDICAL DEVICE
- 3.12 NORMAL USE
- 3.13 PATIENT
- 3.14 PRIMARY OPERATING FUNCTION
- 3.15 REMINDER SIGNAL
- 3.16 RESPONSIBLE ORGANIZATION
- 3.17 USABILITY
- 3.18 USABILITY ENGINEERING
- 3.19 USABILITY ENGINEERING FILE
- 3.20 USABILITY SPECIFICATION
- 3.21 USE ERROR
- 3.22 USE SCENARIO
- 3.23 USER
- 3.24 USER INTERFACE
- 3.25 USER PROFILE
- 3.26 VALIDATION
- 4 Principles
- 5 USABILITY ENGINEERING PROCESS
- 6 ACCOMPANYING DOCUMENT
- 7 Training and materials for training
- CFR 820 Code of Federal Regulations Title 21
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- Sandbox