Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Purpose
2 Scope
3 Relationship to other standards
4 Terms and definitions
5 Regulatory context
6 Safety case model for a generic medical device
7 Generation of system and sub-system hazards
8 Confidence case
9 Challenge
10 Common mistakes to avoid
11 Developing a safety case for an existing device
12 Safety cases and risk management
13 Lifecycle management
14 Maintaining the safety case
15 Styles of safety case notation
Annex A (informative) - Assurance cases and evidence
of substantial equivalence
Annex B (informative) - Safety case model examples
Annex C (informative) - AdvaMed Infusion Pump
Assurance Case (IPAC) Template
Annex D (informative) - Tool selection considerations
Annex E (informative) - Developing a safety case for
an existing product
Annex F (informative) - Lessons learned regarding
safety cases
Bibliography