EVS-EN ISO 10993-5:2009

Meditsiinivahendite bioloogiline hindamine. Osa 5: Katsed tsütotoksilisuse hindamiseks - in vitro meetodid

Kehtiv alates 07.08.2009
ISO 10993-5:2009; EN ISO 10993-5:2009

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EN ISO 10993-5 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

In vitro cytotoxicity tests have been in widespread use in evaluating a large range of devices and materials. Instead of describing a single test, it is the purpose of EN ISO 10993-5 to define a scheme for testing.

Three categories of test are listed in EN ISO 10993-5: extract test, direct contact test, indirect contact test. The choice of one of these categories depends upon the nature of the sample, potential site and nature of use.

This choice then determines the details of the preparation of the samples to be tested, the preparation of the cultured cells, and the way in which the cells are exposed to the samples or their extracts.
There are several means of producing results in each of these four categories.

The investigator should be aware of the test categories and into which category a particular technique fits, in order that comparisons be able to be made with other results on similar devices or materials both at the intra- and interlaboratory level

The international standard has been approved in Europe as EN ISO 10993-5:2009 without any changes and it supersedes EN ISO 10993-5:1999.
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