Committee representation
Foreword
Introduction
1 Scope
2 References
3 Definitions and abbreviations
4 Intended clinical use and indications
5 System description
5.1 Principle of operation
5.2 Design consideration
5.3 System configuration
5.4 System performance and operating limits
5.5 Design analysis
5.6 Risk analysis
5.7 Human factors
5.7.1 General
5.7.2 Specific human factors considerations
6 In vitro design evaluation
6.1 In vitro test setup
6.2 "Worst-case" operating conditions
6.3 Fluid dynamics
6.4 Software verification and validation
6.5 Electrical qualification
6.5.1 Electromagnetic compatibility
6.5.2 Electrical safety
6.6 Power sources
6.6.1 Transcutaneous energy transmission systems
6.6.2 Batteries
6.7 Mechanical qualification
6.7.1 Connections and connectors
6.7.1.1 Electrical
6.7.1.2 Pneumatic/gas
6.7.1.3 Blood/conduits
6.7.2 Vascular grafts
6.7.3 Valves
6.7.4 Materials qualification
6.8 Biocompatibility
6.9 Environmental testing
7 In vivo design evaluation
7.1 In vivo study plan
7.2 In vivo protocol
7.3 In vivo analysis plan
8 Reliability
9 Clinical trial considerations
10 Labeling
10.1 General
10.2 Instructions for use
10.2.1 General
10.2.2 Contra-indications and associated precautions
10.2.3 Human factors considerations
Annexes
A - Rationale for the development and provisions of this
technical information report
B - Example environmental testing matrix
C - Bibliography