AAMI TIR42 : 2010
Superseded
View Superseded by
EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES
English
01-01-2010
04-06-2021
Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Considerations for evaluating particulates
5 Sources of particulates
6 Establishment of product particle limits
7 Test methods for collection and analysis of particulate
matter
8 Clinical significance of particulate matter
Annex A (informative) - Summary of particulate technologies
Bibliography
Describes vascular exposure to particles arising from the manufacturing environment for vascular medical devices and from the use of vascular medical devices.
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
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