ISO 10993-5 Cytotoxicity Testing

The cytotoxicity test in the ISO 10993-5:2010 standard is one of the primary biocompatibility tests conducted within the scope of medical device biological risk assessment.

In vitro cytotoxicity testing can:

- Inhibit the proliferation of cells interacting with the medical device under laboratory conditions.

- Qualitatively and quantitatively determine their lethal (cytotoxic) effects on cells.

To achieve this, testing is performed directly with the medical device. Cytotoxic effects may occur due to interactions with substances that leach from the device. More commonly, cytotoxic effects are assessed through direct interactions between the device and cells. Extracts from medical devices are obtained using solvents that may be polar, non-polar, or both.

Testing Methods at JJR Analytical Laboratory

In the cell culture laboratory at JJR Analytical Laboratory, the following tests are conducted by expert personnel within the scope of ISO 10993-5:

1.MTT Test

2.Agar Diffusion Test

3.Filter Diffusion Test

Both customers and our laboratory can recommend which tests should be performed.

1. MTT Test

- Conducted on standardized, certified L929 fibroblast cells at different concentrations of medical device extracts.

- Extracts are obtained using polar, non-polar, or semi-polar solvents.

- Resulting toxicity is measured using a colorimetric method.

2. Agar Diffusion Test

- An agar layer is formed over L929 fibroblast cells grown in a petri dish.

- Substances leaching from:

- The medical device placed directly on the agar.

- Test materials impregnated with medical device extracts.

- These substances pass through the agar layer, reach the cells, and may cause lethal effects.

- Effects are semi-quantitatively evaluated.

3. Filter Diffusion Test

- Cells grown on a filter (with a specific pore size) are inverted and covered with agar.

- Substances leaching from:

- The medical device applied directly to the filter.

- Material impregnated with the extract.

- These substances pass through the filter and reach the cells.

- Semi-quantitative evaluation is performed by measuring the diameter of the cell-free area formed.

Testing and Compliance

- Depending on the nature of the product, one or multiple tests may be conducted to assess medical device cytotoxicity.

- At JJR Laboratory in China, our experts conduct cytotoxicity studies on L929 fibroblast cells and various cell lines for each product as required.

1.Cytotoxicity testing is mandatory for all products requiring biocompatibility testing.

2.It is one of the primary tests in biocompatibility assessment.

3.The performance and reliability of these tests are crucial, as they serve as a reference for other biocompatibility tests.

To ensure quality and reliability, our laboratory holds a GLP compliance statement—an important quality certification, providing confidence to our clients.

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