WebCytotoxicity testing evaluates the biological reactivity of mammalian cells and tissues to contact with elastomeric plastics, excipients, and other materials that will come in direct or indirect patient contact during medical product use. Thus, sometimes cytotoxicity testing is referred to as biological reactivity testing. Web3.1 Biological Reactivity 3.2 Physicochemical 3.3 Extractable Elements 4. TEST METHODS 4.1 Biological Reactivity 4.2 Physicochemical 4.3 Appearance (Turbidity/Opalescence) 4.4 Color 4.5 Acidity or Alkalinity 4.6 Absorbance 4.7 Reducing Substances 4.8 Volatile Sulfides
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WebMay 17, 2024 · The systemic injection test and the intracutaneous test are used for elastomeric materials, especially elastomeric closures for which the appropriate biological reactivity tests, in vitro (USP <87>), have indicated significant biological reactivity. These two tests are used for plastics and other polymers, in addition to a third test, the ... http://pharmacopeia.cn/v29240/usp29nf24s0_c87.html lynn rishell
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http://pharmacopeia.cn/v29240/usp29nf24s0_c87.html WebThe cytotoxicity tests performed for your medical device or product depend upon the final product’s packaging, intended use, and material construction. Three in-vivo cytotoxicity tests are used to assess systemic biological reactivity. These tests are implantation, intracutaneous injection, and systemic injection studies. WebApr 9, 2024 · Polydimethylsiloxane (PDMS) has been widely used to make lab-on-a-chip devices, such as reactors and sensors, for biological research. Real-time nucleic acid testing is one of the main applications of PDMS microfluidic chips due to their high biocompatibility and transparency. However, the inherent hydrophobicity and excessive … kioa v west citation