STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Pyrogenicity Testing service for the medical device industry. This new testing follows the biocompatibility guidelines modified for medical devices.
Due to the risks associated with medical devices, comprehensive medical device testing throughout the product life cycle is a critical step in the transformation process from an innovative design to a reliable and 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 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 of a system, not damage to individual cells or organs. Systemic toxicity tests include acute systemic toxicity tests and pyrogenic tests.
“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 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 of medical devices or chemical materials. Material-mediated pyrogens assess the potential for pyrogenic reactions from chemicals in/on medical devices. Notably, there is no single test that can differentiate between material-mediated pyrogenic responses and those caused by endotoxin contamination. The animals are dosed with the test article extract and observed for 3 hours.
For Pyrogenicity Test, STEMart offers Limulus amebocyte lysate (LAL) reagent test, the test method, for customers to solve problems in the medical devices testing process. In addition, STEMart also offers acute toxicity for medical devices industry, which is considered to be the adverse effects that occur after administration of a single dose or repeated doses of a test article given within 24 hours. 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 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.