Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-4
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Types of devices in contact with blood (as categorized
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
6.2.1 Recommended tests for interactions of devices
with blood
6.2.2 Non-contact devices
6.2.3 External communicating devices
6.2.4 Implant devices
6.2.5 Indications and limitations
6.3 Types of tests
6.3.1 In vitro tests
6.3.2 Ex vivo tests
6.3.3 In vivo tests
Annexes
A - Preclinical evaluation of cardiovascular devices and
prostheses
B - Laboratory tests-Principles, scientific basis, and
interpretation
C - Evaluation of hemolytic properties of medical devices
and their components
Bibliography
Tables
Figure