| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 01.04.2014 13:19:08 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.5 USABILITY SPECIFICATION |
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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
- 4 Principles
- 5 USABILITY ENGINEERING PROCESS
- 5 USABILITY ENGINEERING PROCESS
- 5.1 Application specification
- 5.2 Frequently used functions
- 5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS
- 5.4 PRIMARY OPERATING FUNCTIONS
- 5.5 USABILITY SPECIFICATION
5.5 USABILITY SPECIFICATION
«Functional» 5.5 Testable requirements for USABILITY VERIFICATION- «Functional» 5.5 Testable requirements for USABILITY of the PRIMARY OPERATING FUNCTIONS including RISK CONTROL
- «Functional» 5.5 Inputs include application specification
- «Functional» 5.5 Inputs include PRIMAR OPERATING FUNCTIONS
- «Functional» 5.5 Inputs include HAZARDS and HAZARDOUS SITUATIONS
- «Functional» 5.5 Inputs include known and foreseeable USE ERRORS
- «Functional» 5.5 Describe USE SCENARIOS
- «Functional» 5.5 Describe USER INTERFACE requirements
- «Functional» 5.5 Describe requirements for determing whether PRIMARY OPERATING FUNCTIONS are easily recognizable
- 5.6 USABILITY VALIDATION plan
- 5.7 USER INTERFACE design and implementation
- 5.8 USABILITY VERIFICATION
- 5.9 USABILITY VALIDATION
- 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