DIN EN ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

Foreword

This European Standard specifies the relevant requirements of EC Directive 93/42/EEC concerning medical devices in accordance with the current specifications of the EU Commission. 

Introduction 

There are many parts of ISO EN 10993 that deal with the various aspects of the biological evaluation of the wide range of medical devices. The complete work provides a comprehensive process and a large collection of test schemes and methods for biological evaluation.

The application of in vitro cytotoxicity testing is generally applicable to the wide range of medical devices. Therefore, a test scheme and guidance for the evaluation of the results are given in this standard. The endpoints measured can be evaluated according to the following categories: Cell Damage Due to Morphological Alteration, Cell Damage, Cell Growth, Aspects of Cell Metabolism. 

Scope of Application 

Part 5 of this standard specifies the procedures for testing in vitro cytotoxicity, by culturing mammalian cells either in direct contact with the medical device and/or with the extracts. This involves testing the extent to which a material has a destructive effect on the growth of mammalian cells. 

Determination of cytotoxicity 

The following table of the standard specifies how the results of the tests are to be evaluated in accordance with the qualitative morphological assessment of cytotoxicity.

Assessment of the results 

In vitro cytotoxicity may be an initial indication of in vivo cytotoxicity and should be investigated further.