IEC TR 80002-1:2009
Current
The latest, up-to-date edition.
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
09-23-2009
FOREWORD
INTRODUCTION
1 General
1.1 Scope
1.2 Normative references
2 Terms and definitions
3 General requirements for RISK MANAGEMENT
3.1 RISK MANAGEMENT PROCESS
3.2 Management responsibilities
3.3 Qualification of personnel
3.4 RISK MANAGEMENT plan
3.5 RISK MANAGEMENT FILE
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
5 RISK EVALUATION
6 RISK CONTROL
6.1 RISK reduction
6.2 RISK CONTROL option analysis
6.3 Implementation of RISK CONTROL measure(s)
6.4 RESIDUAL RISK EVALUATION
6.5 RISK/benefit analysis
6.6 RISKS arising from RISK CONTROL measures
6.7 Completeness of RISK CONTROL
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and POST-PRODUCTION information
Annex A (informative) - Discussion of definitions
Annex B (informative) - Examples of software causes
Annex C (informative) - Potential software-related pitfalls
Annex D (informative) - Life-cycle/risk management grid
Annex E (informative) - SAFETY cases
Bibliography
Index
Index of defined terms
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