EN 30993-5:1994

Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods (ISO 10993-5:1992)

General information

99.60 Withdrawal effective   May 15, 1999

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.020   Medical sciences and health care facilities in general

Scope

This part of ISO 10993 describes test methods to assess the in-vitro cytotoxicity of medical and dental materials and devices. These methods specify the incubation of cultured cells either directly or through diffusion: a) with extracts of the material or of the device and/or b) in contact with a material or device. These methods are designed to determine the biological response of mammalian cells in-vitro using appropriate biological parameters.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 30993-5:1994
99.60 Withdrawal effective
May 15, 1999

REVISED BY

WITHDRAWN
EN ISO 10993-5:1999

Relations

Adopted from ISO/DIS 10993-5 IDENTICAL