Page 16 - Safety Risk Management for Medical Devices

LIST OF TABLES

Table 3.1 Special Vocabulary of Risk Management 9
Table 6.1 Hazard Taxonomy 26
Table 11.1 Example of Harms Assessment List 62
Table 12.1 Example Criticality Matrix 86
Table 12.2 Sample Design Failure Modes and Effects Analysis 97
Table 12.3 Definitions of DFMEA Severity Ratings 98
Table 12.4 Definitions of DFMEA Occurrence Ratings 99
Table 12.5 DFMEA Detectability Ratings 99
Table 12.6 Design Failure Modes and Effects Analysis RPN Table 101
Table 12.7 PFMEA Severity Rankings 107
Table 12.8 PFMEA Occurrence Ratings 108
Table 12.9 PFMEA Detectability Ratings 109
Table 12.10 Process Failure Modes and Effects Analysis RPN Table 109
Table 12.11 Taxonomy of User Actions 112
Table 12.12 Definitions of UMFMEA Severity Ratings 115
Table 12.13 Definitions of UMFMEA Occurrence Ratings 115
Table 12.14 Definitions of UMFMEA Detectability Ratings 116
Table 12.15 Use-Misuse Failure Modes and Effects Analysis RPN Table 117
Table 15.1 Definitions of Software Failure Modes and Effects Analysis Severity Ratings 134
Table 15.2 Definitions of Software Failure Modes and Effects Analysis Occurrence 135
Ratings
Table 15.3 Software Failure Modes and Effects Analysis Detectability Ratings 136
Table 15.4 Software Failure Modes and Effects Analysis Criticality Table 136
Table 15.5 SDFMEA S-D Criticality Table 137
Table 15.6 Harm Severity Versus Software Safety Class 139
Table 15.7 Additional Documents for the Risk Management File 143
Table 17.1 Example Three-Level Definitions for Severity 158
Table 17.2 Example Three-Level Definitions for Probability 158
Table 17.3 Example Five-Level Definitions for Severity 158
Table 17.4 Example Five-Level Definitions for Probability 159
Table 21.1 Confidence/Reliability (C/R) and Attribute Sample Sizes 181
Table 21.2 Attribute-Test Sample Sizes 181
Table 26.1 Definitions of Severity Based on ISO 14971 Table D.3 206
Table 26.2 Risk Management Input to Clinical Documentation 208

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