MEDICAL DEVICE SOFTWARE - PART 1: GUIDANCE ON THE APPLICATION OF ISO 14971 TO MEDICAL DEVICE SOFTWARE
International Electrotechnical Committee
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
Gives guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software - Software life cycle processes.
| Document Type | Standard |
| Status | Current |
| Publisher | International Electrotechnical Committee |
| Committee | TC 62 |
