AAMI ISO 10993-4 : 2002
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Hardcopy , PDF
01-02-2018
English
01-01-2009
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
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