Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Types of devices in contact with blood
(as categorised in ISO 10993-1)
5.1 Non-contact devices
5.2 External communicating devices
5.3 Implant devices
6 Characterization of blood interactions
6.1 General requirements
6.2 Categories of tests and blood interactions
6.3 Types of test
Annex A (informative) Preclinical evaluation of
cardiovascular devices and prostheses
Annex B (informative) Laboratory tests - Principles,
scientific basis and interpretation
Annex C (informative) Evaluation of haemolytic properties
of medical devices and their components
Bibliography