biomaterials are evaluated to determine if the produce an unwanted FlashpointFlashpoint is used to determine the temperature at which a liquid or volatile solid gives off vapor sufficient to form an ignitable mixture with the air just above the surface of the sample within the test vessel. We strive to offer the most effective business practices while employing a staff of technical experts. devices or other devices that may come into contact with the body. The first step to evaluating potential risk is to identify the chemistries extracted under aggressive conditions. This can include colorants, plasticizers, specific metals, and ceramics, for example. ISO 10993-18 offers a five-step process for evaluating the biological safety of medical devices: Materials characterization is needed in steps 1-3 and EAG offers complete suite of services. This can be evaluated through a comprehensive chemical comparative study to investigate the extractable profiles and/or surface chemistries. Whether your business is local or global, we can help to ensure that your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world. Residue on IgnitionThis test determines the total mineral content of a sample or extract when ignited to 800C in a muffle furnace. Water for Injection, USPUSP requirements for water for injection include water conductivity and total organic carbon.
Copyright 2012 Woodhead Publishing Limited. Due to the difficulty in obtaining a priori information on all the constituents in finished devices, information generation strategies in the form of analytical chemistry testing are often used. Also known as Chemical Characterization of Materials, Part 18 activities help assess a devices overall biological safety, measure leachables, evaluate material equivalency and help screen new materials for suitability. Heavy MetalsThis USP semi-quantitative test determines whether the total level of metallic impurities that react with the sulfide ion, under test conditions, exceeds the heavy metals limit specified in the individual USP monograph. Copyright 2022 Elsevier B.V. or its licensors or contributors.
Subsequently, during the final product lifecycle these compounds might migrate into the patient body causing unintended harmful consequences. Regulatory bodies are looking for this as part of the assessment of risk associated with your product.
Melting PointThe melting point of a chemical is the temperature at which a substance changes physical state from a solid to a liquid at normal atmospheric pressure.