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DIN Standards Committee Optics and Precision Mechanics

Abstract

This document describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. This European amendment is intended to add the Annex ZA to the Medical Device Regulation. It is not an amendment to the ISO text.

Begin

2024-10-25

WI

00206109

Planned document number

DIN EN ISO 10993-5/A11

Project number

02703454

Responsible national committee

NA 027-07-12 AA - Biological evaluation of medical devices  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

previous edition(s)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
2009-10