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

Cytotoxicity - ISO 10993-5
A cytotoxicity test determines whether a product or compound will have any toxic effect due to leachables on living cells. Generally used as a screening tool for raw materials or component products before they are put into the design of a medical device.

Test Code Test Description Minimum Sample Requirements Turnaround time
CY-NGLP

Cytotoxicity Test
ISO MEM Elution, Non-GLP Compliant

Sample needed: 120 cm2 if sample is <   0.5 mm thick,
 60 cm2 if sample is > 0.5 mm thick, 4 grams

3-4 weeks

CY-GLP

Cytotoxicity Test
ISO MEM Elution, GLP Compliant

3-4 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)