DS/EN 30993-5:1994
Biological evaluation of medical devices-Part 5:Tests for cytotoxicity-in vitro methods

Standard No.

DS/EN 30993-5:1994

Release Date

1994

Published By

Danish Standards Foundation

Status

Withdraw

Latest

DS/EN 30993-5:1994

Scope

This part of ISO 10993 describes test methods to as-sess the in vitro cytotoxicity of medical devices. NOTE 1 The term medical devices corresponds to the definition given in ISO 10993-1 and covers medical ma-terials as well as dental material and devices. The definition is in accordance with the CEN standard document. These methods specify the incubation of cultured cells either directly or through diffusion a) with extracts of the device, and/or b) in contact with a device. These methods are designed to determine the bio-logical response of mammalian cells in vitro using ap-propriate biological parameters.

DS/EN 30993-5:1994 history

• 1994 DS/EN 30993-5:1994 Biological evaluation of medical devices-Part 5:Tests for cytotoxicity-in vitro methods