EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of USP 88 testing. Elastomerics, plastics, or other polymeric materials with direct or indirect patient contact should be tested for adverse effects.
Extracts of the ingredients are prepared and injected into a rodent species. Animals are monitored for any systemic or local reactions. Many factors can affect the suitability of the material for a particular use. Material composition, processing and cleaning procedures, adsorption and permeability of inks, adhesives, preservatives, sterilization method, and storage conditions can affect material performance.
There are three in vivo tests involved in the classification of plastics. The Systemic Injection Test and Intracutaneous Test are designed to determine systemic and local biological responses to plastics and other polymers by a single dose injection of specific extracts prepared from a sample. The third test, the Implantation Test, is designed to assess the response of living tissue to a test material. Tests for six different grades of plastics are done using different combinations of these three tests and different extracts.
The USP class plastic tests are designed to evaluate the biological reactivity of various plastic materials in vivo. Originally developed to test pharmaceutical containers, plastic grade tests are often performed on unmolded plastic resins as well as containers. Plastic grade testing is not a substitute for medical device biocompatibility testing, medical device materials are recommended to follow ISO guidelines, but bioreactivity grade plastic testing is often used by manufacturers to classify materials.
EUROLAB assists manufacturers with USP 88 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
