Biocompatibility
Every medical device must be subjected to three common biocompatibility tests (often referred to as the Big Three): cytotoxicity, sensitization and irritation tests. Each test screens for the presence of toxic, leachable materials. Based on the category of the device, as many as five additional testing categories may be required. Biocompatibility and Toxicology tests are done inconjunction with our partner lab, Bioserasi.
Test List
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Test Code | Method Name | Description | Estimated TAT (days) | Test methods (accredited) |
|---|---|---|---|---|
MBS913 | Genotoxicity: COMET Assay | Genotoxicity: COMET Assay (SCGE) | 20 days | Contact Us |
MBS921 | Skin Corrosivity Test | Skin Corrosivity & Irritational Test (OECD) | 4 weeks | Contact Us |
MBS922 | Skin Irritation Test | Primary Skin Irritation (ISO 10993-10) | 17 days | Contact Us |
MBS922B | Biocompatibility and Toxicology | Primary Skin Irritation (FDA) | 20 days | Contact Us |
MBS923 | Biocompatibility and Toxicology | Cumulative Skin Irritation | 5 weeks | Contact Us |
MBS924 | Intracutaneous Reactivity | Intracuteneous Reactivity | 17 days | Contact Us |
MBS925 | Skin Sensitisation - Buehler | Skin Sensitisation (Buehler -ISO 10993-10) | 7 weeks | Contact Us |
MBS926 | Skin Sensitization - GPMT | Skin Sensitisation (GPMT) - Polar or Non-polar solvents) | 6 weeks | Contact Us |
MBS927 | Pyrogenicity - Main Test | Pyrogenicity (Rabbit), USP: Main Test (-1000) | 17 days | Contact Us |
MBS928 | Pyrogenicity - Continuing Test | Pyrogenicity (Rabbit), USP: Continuing Test | 17 days | Contact Us |
MBS931 | Acute Toxicity - Limit Test | Acute Toxicity (Oral): Limit Test (2000 mg/Kg) | 4 weeks | Contact Us |
MBS932 | Acute Toxicity - Main Test | Acute Toxicity (Oral): Main Test - 1-4 doses (per dose) | 4 weeks | Contact Us |
MBS933 | Acute Toxicity - intraperitoneal | Acute Toxicity (i/p) single dose | 4 weeks | Contact Us |
MBS934 | Acute Toxicity - dermal | Acute Toxicity (dermal) single dose | 4 weeks | Contact Us |
MBS935 | Acute Toxicity - intravenous | Acute Toxicity (i/v) single dose | 4 weeks | Contact Us |
MBS901 | Cytotoxicity: MEM Elution | Cytotoxicity: MEM Elution (5 dose levels) - ISO 10993-5 | 14 days | Contact Us |
MBS902 | Cytotoxicity: MTT Assay | Cytotoxicity: MTT Assay (6 conc.) | 14 days | Contact Us |
MBS911 | Genotoxicity: Ames Test | Genotoxicity: Ames Test, 1 extract, 5 strains | 35 days | Contact Us |
MBS912 | Genotoxicity: Micronucleus Assay | Genotoxicity: Micronucleus Assay (in vitro) | 35 days | Contact Us |
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