ISO 10993-5

Biological Evaluation of Medical Devices

This test method describes 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 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.

In-Vitro Testing Laboratory

Scientists in our In-Vitro testing labs are well trained on ASTM, AATCC, AOAC, CLSI and EN standard methods. The efficacy testing services of this laboratory include MIC/MBC, ...