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AAMI 10993-5

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Biological evaluation of medical devices – Part 5: Tests for in vitrocytotoxicity
2009 Edition, 2009
Includes all amendments and changes through Reaffirmation Notice , 2014

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Description

  • Revision:2009 Edition, 2009
  • Published Date:January 2014
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:50
  • ANSI Approved:Yes
  • DoD Adopted:No
  • This part of ISO 10993 describes test methods to assess the invitro cytotoxicity of medical devices.

    These methods specify the incubation of cultured cells incontact with a device and/or extracts of a device either directlyor through diffusion.

    These methods are designed to determine the biological responseof mammalian cells in vitro using appropriate biologicalparameters.