GEN 162 Cytotoxicity Tests (ISO 10993-5)

The ISO 10993-5 standard, developed by the International Organization for Standardization (ISO), defines test methods for evaluating the in vitro cytotoxicity of medical devices. These test methods involve the incubation of cultured cells in contact with a device or extracts of a device, either directly or via diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. The full name of the standard is : ISO 10993-5 Biological evaluation of medical devices - Part 5: In vitro cytotoxicity tests.

Because of the general applicability of in vitro cytotoxicity tests and their widespread use in evaluating a variety of devices and materials, the aim of the ISO 10993-5 standard is to define a test scheme requiring decision-making in a series of steps, rather than specifying a single test. This should lead to the selection of the most appropriate test.

Three test categories are defined in the ISO 10993-5 standard: extract test, direct contact test and indirect contact test. The choice of one or more of these categories depends on the nature of the sample to be evaluated, the potential use, and the nature of the use.

This selection then determines the details of the preparation of the samples to be tested, the preparation of the cultured cells, and the way the cells are exposed to the samples or extracts.

At the end of the exposure period, an assessment of the presence and extent of the cytotoxic effect is made. The purpose of this standard is to leave the choice of assessment type open.

The numerous methods and measured endpoints used in cytotoxicity detection can be grouped into the following assessment groups:

• Evaluation of cell damage by morphological means
• Measurements of cell damage
• Measurements of cell growth
• Measurements of certain aspects of cellular metabolism

Guidance for the interpretation of results is given in this standard.

For the purposes of this standard,

• Culture dishes refer to containers suitable for cell culture, including glass petri dishes, plastic culture bottles or plastic multi-wells and microtiter plates.
• Positive control material refers to material that produces a reproducible cytotoxic response when tested according to this standard.

Our organization also provides cytotoxicity testing services within the scope of the GEN 162 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.