Biocompatibility & Toxicology

Petri Dish
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:
  • ISO 10993
  • ISO 18562
  • US FDA Guidance Document on ISO 10993-1 (Sep 2016)
  • MDR Regulation (EU) 2017/745 of the European Parliament and the Council of 05 April 2017 on Medical Devices
Test Code
Test Method
MBS901
Cytotoxicity: MEM Elution (5 dose levels) - ISO 10993-5
MBS902
Cytotoxicity: MTT Assay (6 conc.)
MBS911
Genotoxicity: Ames Test, 1 extract, 5 strains
MBS912
Genotoxicity: Micronucleus Assay (in vitro)
MBS913
Genotoxicity: COMET Assay (SCGE)
MBS921
Skin Corrosivity & Irritational Test (OECD)
MBS922A
Primary Skin Irritation (ISO 10993-10)
MBS922B
Primary Skin Irritation (FDA)
MBS923
Cumulative Skin Irritation
MBS924
Intracutaneous Reactivity
MBS925
Skin Sensitisation (Buehler -ISO 10993-10)
MBS926
Skin Sensitisation (GPMT) - Polar or Non-polar solvents)
MBS927
Pyrogenicity (Rabbit), USP: Main Test (-1000)
MBS928
Pyrogenicity (Rabbit), USP: Continuing Test
MBS931
Acute Toxicity (Oral): Limit Test (2000 mg/Kg)
MBS932
Acute Toxicity (Oral): Main Test - 1-4 doses (per dose)
MBS933
Acute Toxicity (i/p) single dose
MBS934
Acute Toxicity (dermal) single dose
MBS935
Acute Toxicity (i/v) single dose
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Lab Experiments
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