| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 01.04.2014 13:01:54 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 5.3.2 Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS |
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Overview- Organisation Chart
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- 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
- 5.3 Identification of HAZARDS and HAZARDOUS SITUATIONS
- 5.3.1 Identification of characteristics related to SAFETY
- 5.3.2 Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
5.3.2 Identification of known or foreseeable HAZARDS and HAZARDOUS SITUATIONS
«Functional» 5.3.2 Identify HAZARDS consider to PATIENTS, USERS and other persons- «Functional» 5.3.2 Identify combinations of events involving the USER INTERFACE
- «Functional» 5.3.2 Consider application specification, including USER PROFILE
- «Functional» 5.3.2 Consider task related requirements
- «Functional» 5.3.2 Consider context of use
- «Functional» 5.3.2 Consider information of exisiting or similar MEDICAL DEVICES
- «Functional» 5.3.2 Consider preliminary USE SCENARIOS
- «Functional» 5.3.2 Consider possible USE ERRORS
- «Functional» 5.3.2 Consider if an incorrect mental model of the operation can cause a USE ERROR
- «Functional» 5.3.2 Consider results of the review of the USER INTERFACE
- 5.4 PRIMARY OPERATING FUNCTIONS
- 5.5 USABILITY SPECIFICATION
- 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