| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 14.03.2014 11:25:00 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 4.4 Estimation of the risk(s) for each hazadous situation |
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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
- ISO 14971 Requirements
- 2 Terms an definitions
- 3. General requirements for risk management
- 4. Risk analysis
- 4. Risk analysis
- 4.1 Risk analysis process
- 4.2 Intended use and identification of characteristics related to the safety of the medical device
- 4.3 Identification of hazards
- 4.4 Estimation of the risk(s) for each hazardous situation
4.4 Estimation of the risk(s) for each hazadous situation
«Functional» 4.4 Record reasonably forseeable sequences or combinations of events that result in a hazardous situation- «Functional» 4.4 Estimate risk for each identified hazadous situation
- «Functional» 4.4 Record system used for the qualitative or quantitative categorization of probability or severity
- 5. Risk evaluation
- 6. Risk control
- 7. Evaluation of overall residual risk acceptability
- 8. Risk management report
- 9. Production and post-production information
- Anhang ZA
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- 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