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
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MBS921
Skin Corrosivity Test
Skin Corrosivity & Irritational Test (OECD)
4 weeks
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MBS922
Skin Irritation Test
Primary Skin Irritation (ISO 10993-10)
17 days
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MBS922B
Biocompatibility and Toxicology
Primary Skin Irritation (FDA)
20 days
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MBS923
Biocompatibility and Toxicology
Cumulative Skin Irritation
5 weeks
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MBS924
Intracutaneous Reactivity
Intracuteneous Reactivity
17 days
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MBS925
Skin Sensitisation - Buehler
Skin Sensitisation (Buehler -ISO 10993-10)
7 weeks
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MBS926
Skin Sensitization - GPMT
Skin Sensitisation (GPMT) - Polar or Non-polar solvents)
6 weeks
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MBS927
Pyrogenicity - Main Test
Pyrogenicity (Rabbit), USP: Main Test (-1000)
17 days
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MBS928
Pyrogenicity - Continuing Test
Pyrogenicity (Rabbit), USP: Continuing Test
17 days
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MBS931
Acute Toxicity - Limit Test
Acute Toxicity (Oral): Limit Test (2000 mg/Kg)
4 weeks
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MBS932
Acute Toxicity - Main Test
Acute Toxicity (Oral): Main Test - 1-4 doses (per dose)
4 weeks
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MBS933
Acute Toxicity - intraperitoneal
Acute Toxicity (i/p) single dose
4 weeks
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MBS934
Acute Toxicity - dermal
Acute Toxicity (dermal) single dose
4 weeks
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MBS935
Acute Toxicity - intravenous
Acute Toxicity (i/v) single dose
4 weeks
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MBS901
Cytotoxicity: MEM Elution
Cytotoxicity: MEM Elution (5 dose levels) - ISO 10993-5
14 days
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MBS902
Cytotoxicity: MTT Assay
Cytotoxicity: MTT Assay (6 conc.)
14 days
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MBS911
Genotoxicity: Ames Test
Genotoxicity: Ames Test, 1 extract, 5 strains
35 days
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MBS912
Genotoxicity: Micronucleus Assay
Genotoxicity: Micronucleus Assay (in vitro)
35 days
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Other Tests 
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Contact us at +606-7947 606
OR