Standard: AAMI 10993-5

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY

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Scope:

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.

These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.

These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 10993-5
Publish Date: 2009-01-01
Page Count: 50
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
AAMI 10993-5 Change Type: STCH Update Date: 2009-01-01 Revision: 09 Status: ACTV

This Standard References

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