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ISO 14971 Risk management
Anhang ZA
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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
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
Anhang ZA
«Functional» 1. Berücksichtigung sämtlicher Risiken
«Functional» 2. Verminderung sämtlicher Risiken
«Functional» 3. Kein Einfluss ökonomischer Faktoren auf ALARP-Konzept
«Functional» 4. Risiko-Nutzen-Analyse in jedem Fall durchführen
«Functional» 5. Anwendung sämtlicher Wahlmöglichkeiten zur Risikobeherrschung
«Functional» 6. Beseitigung oder Minderung der Risiken während Entwicklung und Produktion
«Functional» 7. Nutzerinformationen stellen keine Risikominderung dar
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
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Anhang ZA :
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General :
Version:
1.0
Project :
Author:
Wolfgang Kern
Status:
Approved
Created:
02.06.2014 16:47:53
Modified:
00:00:00
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