SANS 10993-5:2003
Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity

Standard No.

SANS 10993-5:2003

Release Date

2003

Published By

ZA-SANS

Status

Withdraw 2010-08

Latest

SANS 10993-5:2003

Scope

Describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion with extracts of a device, and/or in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

SANS 10993-5:2003 history

• 2003 SANS 10993-5:2003 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity