Biocompatibility & Toxicology
Biocompatibility and Toxicology Test for Medical Device
Product safety tests for medical devices that look at the human body's potential risks resulting from the contacts with the devices' materials.
Potential adverse effects can range from short-term (acute) to long-term (chronic) adverse effects to the body such as mutagenic effects.
Complete range of the biological evaluation testing for medical devices are mandated in ISO 10993. Additional tests for evaluating the devices' performance from the biological/microbiological perspectives are also available.
Applicable Standards:
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ISO 10993
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ISO 18562
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US FDA Guidance Document on ISO 10993-1 (Sep 2016)
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MDR Regulation (EU) 2017/745 of the European Parliament and the Council of 05 April 2017 on Medical Devices
Test Method |
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Cytotoxicity: MEM Elution (5 dose levels) - ISO 10993-5 |
Cytotoxicity: MTT Assay (6 conc.) |
Genotoxicity: Ames Test, 1 extract, 5 strains |
Genotoxicity: Micronucleus Assay (in vitro) |
Genotoxicity: COMET Assay (SCGE) |
Skin Corrosivity & Irritational Test (OECD) |
Primary Skin Irritation (ISO 10993-10) |
Primary Skin Irritation (FDA) |
Cumulative Skin Irritation |
Intracutaneous Reactivity |
Skin Sensitisation (Buehler -ISO 10993-10) |
Skin Sensitisation (GPMT) - Polar or Non-polar solvents) |
Pyrogenicity (Rabbit), USP: Main Test (-1000) |
Pyrogenicity (Rabbit), USP: Continuing Test |
Acute Toxicity (Oral): Limit Test (2000 mg/Kg) |
Acute Toxicity (Oral): Main Test - 1-4 doses (per dose) |
Acute Toxicity (i/p) single dose |
Acute Toxicity (dermal) single dose |
Acute Toxicity (i/v) single dose |
