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This guide is limited to procedures used solely for the testing of substances to determine their mutagenicity and does not apply to other methods and uses such as exploring mechanisms of mutation.Recent evidence suggests that this assay measures a dual genetic end point; therefore, some discussion of the relationships between mammalian cell mutagenicity testing results and the results observed both in pure gene mutational assays and in cytogenetic assays is necessary. However, it is not the intent of this guide to discuss other relationships between this mammalian cell mutagenicity testing results and the results observed in other tests for mutagenicity and carcinogenicity.1.1 The purpose and scope of this guide is to present background material and to establish criteria by which protocols and procedures for conducting the L5178Y/TK+/−-3.7.2C mouse lymphoma mutagenicity assay (commonly referred to as the mouse lymphoma assay, (MLA)) can be properly understood and evaluated. This guide is also intended to aid researchers and others to gain a better understanding of the critical elements involved with mammalian cell mutagenicity testing. More specifically, this guide is intended to provide for researchers the accomplishment of the following goals:1.1.1 Provide an understanding of the critical procedures (steps) in the performance of this mammalian cell mutagenicity test.1.1.2 Provide generalized criteria by which researchers can evaluate if they are properly performing, utilizing, and interpreting this assay.1.1.3 Provide criteria by which individuals responsible for evaluating MLA data can determine if the experiments have been properly performed and interpreted.1.1.4 Provide a basis from which new procedures and developments in testing procedures can be evaluated.1.1.5 Provide an understanding of the types of genetic damage (that is, gene and chromosome mutation) that may be detected in this mammalian cell mutagenicity test.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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5.1 This practice is useful for assessing the cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical devices.5.2 This practice is used for assessing the cytotoxic potential of materials intended for the fabrication of inserts or implants in the orofacial region.5.3 This practice is restricted to normal non-transformed, human orofacial tissues using cells cultured in human serum factors and does not depend upon cells and serum from non-human sources.5.4 This practice incorporates procedures to monitor the quality of ingredient materials and the uniformity of the production process for formulating stock compositions.5.5 This practice may be useful to determine the effects of age and radiation, and the state of carcinogenicity on the sensitivity of HED tissues to materials and devices used for orofacial prostheses.1.1 This practice describes a procedure to assess the cytotoxic potential of materials for use in the construction of medical materials and devices using human excised donor (HED) tissues and their derived primary cells taken from the orofacial region.1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity methods may be compared.1.3 This practice is one of a series of reference methods for assessment of cytotoxic potential, employing different techniques.1.4 Assessment of cytotoxicity is one of several procedures employed in determining the biological response to a material, as recommended in Practice F748.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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1.1 This practice provides a protocol for the assessment of the effect of materials used in the fabrication of medical devices, that will contact blood, on the morphology of white blood cells.1.2 This practice is intended to evaluate the acute in vitro effects of materials intended for use in contact with blood.1.3 This practice uses direct contact of the material with blood, and extracts of the material are not used.1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 provides general guidance for the selection of appropriate methods for testing materials for a specific application.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply single source. Appropriate materials and reagents may be obtained from many commercial supply houses.

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This practice covers the procedures used for detection of mycoplasma contamination of cell cultures by growth on agarose medium. This practice does not cover identification of mycoplasma and indirect methods for detection of mycoplasma. This practice will not detect cultivar strains of Mycoplasma hyorhinis nor intended for use in detection of mycoplasma contamination in sera, culture media, vaccines, or other systems. The practice involves DM-1 solid medium preparation, quality control, and mycoplasma isolation.1.1 This practice covers the procedures used for detection of mycoplasma contamination by direct microbiological culture.1.2 This practice does not cover indirect methods for detection of mycoplasma such as DNA staining, biochemical detection, or genetic probes.1.3 This practice does not cover methods for identification of mycoplasma organisms.1.4 This practice will not detect cultivar strains (1) of Mycoplasma hyorhinis.1.5 This practice is not intended for use in detection of mycoplasma contamination in sera, culture media, vaccines, or other systems.This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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