STEMart Launches Pyrogenicity Testing Service for Medical Devices
STEMart launches a pyrogenicity testing service for the medical device industry.
New York, United States – March 29, 2022 – STEMart, a provider of integrated medical device CRO services dedicated to the clinical development of medical devices and diagnostics, is now launching a pyrogenicity testing service for the medical device industry. This new test follows modified biocompatibility guidelines for medical devices.
Due to the risks associated with medical devices, comprehensive testing of medical devices throughout the product life cycle is a critical step in the process of turning an innovative design into a reliable, marketable product. Biocompatibility refers to the appropriate biological requirements for biological materials used in medical devices. Biocompatibility is also described as the ability of a device material to function with an appropriate host response in a particular application. Biocompatibility assessment is an essential part of the overall safety assessment of medical devices. Biocompatibility systemic toxicity tests are in vivo systemic tests used to assess systemic damage or activation of a system, not damage to individual cells or organs. Systemic toxicity tests include acute systemic toxicity tests and pyrogen tests.
“Systemic Toxicity Tests” are part of part 11 of the standards for the biological evaluation of medical devices (ISO 10993-11) and give general considerations to be taken into account when evaluating a medical device for the potential induce acute systemic toxicity and pyrogenicity. According to the study procedures mentioned in the ISO 10993-11 standard for the evaluation of the potential of medical devices and their constituent materials to induce systemic toxicity, STEMart now offers various systemic toxicity testing services.
Pyrogens are compounds of chemical or bacterial origin that cause fever when present in the body in high enough doses. Pyrogenicity tests are used to detect material-mediated pyrogenic reactions caused by extracts from medical devices or chemical materials. Materials-mediated pyrogens assess the potential for pyrogenic reactions of chemicals in/on medical devices. Notably, there is no single test that can differentiate material-mediated pyrogenic responses from those caused by endotoxin contamination. The animals are dosed with the extract of the article to be tested and observed for 3 hours.
For pyrogenicity test, STEMart offers Limulus Amebocyte Lysate Reagent (LAL) test, the testing method, for customers to solve the problems in the medical device testing process. In addition, STEMart also offers acute toxicity for the medical device industry, which is considered to be the adverse effects that occur after administration of a single dose or repeated doses of a test article administered within 24 time. The acute systemic toxicity test determines the systemic toxic effect followed by a single acute exposure of medical biomaterials to the body.
If you have additional questions about medical device pyrogenicity testing or would like to learn more about the medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading e-commerce platform with an extensive global footprint and boasts a large portfolio of over 10,000 products. It aims to provide the best laboratory 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 phase to the manufacturing process. STEMart is dedicated to making biotechnology research and production simpler and safer, and through it to accelerate access to better health for people around the world.
Company Name: STEMart
Contact: Staci Horme
E-mail: Send an email
The country: United States