AAMI ISO 10993-4 : 2002

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

Describes general requirements for evaluating the interactions of medical devices with blood.