BIOCOMPATIBILITY STUDIES
Cytotoxicity
Sensitization
Irritation/Intracutaneous
Acute Systemic Toxicity
Subchronic Toxicity
Genotoxicity
Implantation
Hemocompatibility
Chronic Toxicity
Carcinogenicity
Reproductive/Developmental
Biodegradation

 

 

MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is in compliance with the ISO 13485 quality system, ISO 9001:2008 certified and complies with U.S. GMP and Quality System Regulations. Our experts understand your needs for quality testing and timely, accurate results.

ENVIRONMENTAL MONITORING TESTING SERVICES CONSULTING

 

Test Services

Biocompatibility Studies

Sensitization - ISO 10993-10
Tests for sensitivity to any part of a device during exposure to the body for any length of time. Exposure can create allergic or other sensitive reactions.

Test Code Test Description Minimum Sample Requirements Turnaround time
ST-GLP-30 Kligman Maximization (30 tests) Polar and Non-Polar Extracts Included, GLP Compliant

960 cm2 if sample is < 0.5 mm thick,
 480 cm2 if sample is < 0.5 mm thick, 32 grams, 5 mL,

4-5 weeks

ST-NGLP-30 Kligman Maximization (30 tests) Polar and Non-Polar Extracts Included, Non-GLP Compliant

4-5 weeks

ST-GLP-35 Kligman Maximization (35 tests) Polar and Non-Polar Extracts Included, GLP Compliant

4-5 weeks

ST-NGLP-35 Kligman Maximization (35 tests) Polar and Non-Polar Extracts Included, Non GLP Compliant

4-5 weeks

 

 

Download Sample Submission Form (PDF)

Download Sample Submission Form (Word Doc)

pdfHow To Submit Your Sample Submission Form (PDF)

 

DEKRA-ISO-9001

ISO Certificate
(PDF)