USP 87 细胞毒性 体外试验.docxVIP

87 BIOLOGICAL REACTIVITY TESTS, IN VITRO The following tests are designed to determine the biological reactivity of mammalian cell cultures following contact with the elastomeric plastics and other polymeric materials with direct or indirect patient contact or of specific extracts prepared from the materials under test. It is essential that the tests be performed on the specified surface area. When the surface area of the specimen cannot be determined, use 0.1 g of elastomer or 0.2 g of plastic or other material for every mL of extraction fluid. Exercise care in the preparation of the materials to prevent contamination with microorganisms and other foreign matter.Three tests are described (i.e., the Agar Diffusion Test, the Direct Contact Test, and the Elution Test).:38332/uspnf/pub/data/v38332/usp38nf33s2_c87.xml1 The decision as to which type of test or the number of tests to be performed to assess the potential biological response of a specific sample or extract depends upon the material, the final product, and its intended use. Other factors that may also affect the suitability of sample for a specific use are the polymeric composition; processing and cleaning procedures; contacting media; inks; adhesives; absorption, adsorption, and permeability of preservatives; and conditions of storage. Evaluation of such factors should be made by appropriate additional specific tests before determining that a product made from a specific material is suitable for its intended use. Materials that fail the in vitro tests are candidates for the in vivo tests described in :38332/uspnf/pub/data/v38332/usp38nf33s2_c88.xmlBiological Reactivity Tests, In Vivo 88.:38332/uspnf/pub/data/v38332/usp38nf33s2_c11.xmlUSP Reference Standards 11— USP High-Density Polyethylene RS. USP Positive Bioreaction RS. Cell Culture Preparation— Prepare multiple cultures of L-929 (ATCC cell line CCL 1, NCTC clone 929; alternative cell lines obtained from a standard repository may be used with suitable va