New York, USA – January 26, 2022 – STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Biocompatibility Subacute & Subchronic Toxicity testing for the medical device industry. The testing is designed and performed based on the route of exposure to the body including oral, dermal, and inhalation exposure.
Biocompatibility subacute and subchronic toxicity testing is used to evaluate the possible toxic effects of repeated exposure in patients, including any compound toxicity effects. This test determines the systemic effect of repeated doses of the material or its extract for not less than 24 hours and not exceeding 10% of the total lifespan of the test animal.
Subacute toxicity (repeated dose toxicity) focuses on adverse reactions that occur following single or repeated daily exposure to the test material over a period of 14 to 28 days. Subchronic toxicity refers to the adverse effects of repeated exposure of a substance to a poison over a period of weeks or months. Subacute and subchronic toxicity studies include full clinicopathology (clinical chemistry, hematology, and coagulation), necropsy and organ weights, and histopathology. These tests can be performed with full histopathology or limited tissue evaluation.
The animals of choice for subacute and subchronic toxicity tests are usually mice, rats or rabbits, and oral, dermal, inhalation, intravenous, intraperitoneal or subcutaneous application of the test substance may be used depending on the application of the biological material under consideration.
STEMart now offers biocompatibility subacute and subchronic toxicity testing in accordance with biocompatibility guidelines for medical device modifications. The design and execution of the test is based on the route of exposure to the body, including oral, dermal, and inhalation exposure. General procedures of the subacute & subchronic toxicity testing include administering mice or rats with a dose of 0.9% normal saline or cottonseed extract of the test biomaterial over a 14-day period; observing the test animals once daily for signs of toxicity; recording animal weights on Day 0, Day 7, and Day 14; d). on day 14, collecting blood samples for hematology and clinical chemistry analysis; and conducting a gross necropsy and collecting lesions.
STEMart offers comprehensive biocompatibility testing for both in vitro and in vivo assessments. With extensive expertise in biocompatibility testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks.
If you have additional questions about medical device subacute and subchronic toxicity testing or if you would like to find out more about the medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform with an expanded global footprint and has a broad portfolio of more than 10,000 products. It aims to provide best-in-class lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage towards the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer, and through that to accelerate access to better health for people everywhere.