ISO 10993-5 Biological Evaluation of Medical Devices Tests for in vitro cytotoxicity Austin Zdawczykr Manager, In Vitro Biocompatibility NAMSA
ISO 10993-5 Biological Evaluation of Medical Devices - Tests for In Vitro Cytotoxicity
Jul 22, 2015
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ISO 10993-5
Biological Evaluation of Medical Devices
Tests for in vitro cytotoxicity
Austin Zdawczykr
Manager, In Vitro Biocompatibility
NAMSA
2
ISO 10993-5 presents test methods designed to evaluate the acute adverse effects of extractables from medical devices materials.
3
Testing cytotoxicity is a requirement for all
medical devices.
4
Qualitative- Elution
Different cytotoxicity methods include:
5
Qualitative- Elution
- Agarose Overlay (Indirect Contact)
- Appropriate for leachables which can diffuse through
the agar layer
Different cytotoxicity methods include:
6
Qualitative- Elution
- Agarose Overlay (Indirect Contact)
- Appropriate for leachables which can diffuse through
the agar layer
- Direct Contact
Different cytotoxicity methods include:
7
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:
8
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:
9
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
12
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 [email protected].
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