STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Acute Systemic Toxicity testing for the medical device industry. The testing is following the biocompatibility guidelines modified for medical devices.
Biocompatibility is used to describe the appropriate biological requirements for biological materials used in medical devices. Biocompatibility is also described as the ability of a device material to perform with an appropriate host response in a particular application. Biocompatibility assessment is an essential part of the overall safety evaluation of medical devices. Biocompatibility systemic toxicity tests are in vivo systemic tests used to assess systemic damage or activation, not damage to individual cells or organs. Systemic toxicity tests include acute systemic toxicity tests and pyrogenic tests.
Acute toxicity is considered an adverse reaction that occurs after a single or repeated dose of the test article was administered within 24 hours. Acute systemic toxicity tests determine the systemic toxic effects of medical biomaterials following a single acute exposure to the body. Acute systemic testing can provide broad guidance on health hazards that may result from acute exposure to medical devices or chemical materials. When animal test material extracts or liquid chemicals were administered, subsequently, signs of toxicity are observed at 24 ± 2, 48 ± 2 and 72 ± 2 hours.
“Tests for systemic toxicity” is part 11 of the Biological evaluation of medical devices standards(ISO 10993-11) and gives general considerations to be considered when evaluating a medical device for the potential to induce acute systemic toxicity and pyrogenicity. According to the study procedures mentioned in ISO 10993-11 for the assessing of the potential of medical devices and their constituent materials to induce systemic toxicity, STEMart offers various systemic toxicity testing services.
For Test Methods, STEMart offers acute oral toxicity test, acute dermal toxicity test, acute inhalation toxicity test, acute intravenous toxicity test, and acute intraperitoneal toxicity test. For test animals, STEMart prepares mice, rats, or rabbits. As for Test Items, STEMart provides visual observations of animals, routine hematology and serum chemistry tests with blood samples, and microscopic examination with representative tissue samples.
STEMart offers comprehensive biocompatibility testing for in vitro and in vivo evaluation. With extensive expertise in biocompatibility testing, STEMart can provide a full-service experience that supports manufacturers in meeting regulatory goals and minimizing compliance risk.
If you have additional questions about medical device Acute Systemic 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.