ISO 10993-5

Biological Evaluation of Medical Devices

Tests for in vitro cytotoxicity

Austin Zdawczykr

Manager, In Vitro Biocompatibility

NAMSA

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ISO 10993-5 presents test methods designed to evaluate the acute adverse effects of extractables from medical devices materials.

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Testing cytotoxicity is a requirement for all

medical devices.

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Qualitative- Elution

Different cytotoxicity methods include:

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Qualitative- Elution

- Agarose Overlay (Indirect Contact)

- Appropriate for leachables which can diffuse through

the agar layer

Different cytotoxicity methods include:

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Qualitative- Elution

- Agarose Overlay (Indirect Contact)

- Appropriate for leachables which can diffuse through

the agar layer

- Direct Contact

Different cytotoxicity methods include:

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Qualitative- Elution

- Agarose Overlay (Indirect Contact)

- Appropriate for leachables which can diffuse through

the agar layer

- Direct Contact

Quantitative- Allow for endpoint evaluation

- MTT

- 96 well plate method

Different cytotoxicity methods include:

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Qualitative- Elution

- Agarose Overlay (Indirect Contact)

- Appropriate for leachables which can diffuse through

the agar layer

- Direct Contact

Quantitative- Allow for endpoint evaluation

- MTT

- 96 well plate method

- Colony Assay

- Extraction and direct contact test

- Long term assay

Different cytotoxicity methods include:

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Qualitative- Elution

- Agarose Overlay (Indirect Contact)

- Appropriate for leachables which can diffuse through

the agar layer

- Direct Contact

Quantitative- Allow for endpoint evaluation

- MTT

- 96 well plate method

- Colony Assay

- Extraction and direct contact test

- Long term assay

Special Cell Lines

Different cytotoxicity methods include:

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Negative- HDPE

- Non-sterile tubing for most

assays

- Hatano grade (SRM-C) for

Colony Assay

Cytotoxicity Control Articles

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Negative- HDPE

- Non-sterile tubing for most

assays

- Hatano grade (SRM-C) for

Colony Assay

Positive- Latex for qualitative

- SRM-A and SRM-B (containing

ZDEC and ZDBC) for quantitative

assays

- ZDBC as a chemical for Colony

Assay

Cytotoxicity Control Articles

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To view the complete presentation on ISO 10993-5

Check out NAMSA’s Seminars

You can view the entire ISO 10993 Series here

For information about the services NAMSA can offer you regarding in vitro cytotoxicity

Visit our Biocompatibility page, or

Download our Biocompatibility brochure

For additional information

Contact us at clientcare@namsa.com.