1.1 本规程涵盖了直接接触细胞培养试验的参考方法，该方法可用于评估医用材料和设备结构中使用的材料的细胞毒性潜力。 1.2 本规程可直接用于评估材料，也可作为比较其他细胞毒性试验方法的参考。 1.3 这是使用不同技术评估细胞毒性潜力的一系列参考试验方法之一。 1.4 根据实践中的建议，细胞毒性评估是用于确定对材料的生物反应的几种测试之一 F748 . 1.5 选择L-929细胞系是因为它在这种类型的分析中有着重要的使用历史。这并不意味着优先使用它；只是L-929是一种特性良好、易于获得、已建立的细胞系，已在多个实验室中证明了可重复的结果。 1.6 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.7 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 在评估可能用于医疗应用的新材料或制剂时，以及作为既定医疗材料和医疗设备质量控制计划的一部分，本规程有助于评估细胞毒性潜力。 4.2 本实践假设，细胞毒性潜力评估提供了一种方法，用于预测在临床应用于人类期间对医疗材料和设备的细胞毒性或坏死反应的可能性。一般来说，当只考虑化学毒性时，细胞培养试验方法与动物试验显示出良好的相关性。 注1: 使用该方法获得的结果可能无法预测 体内 受多种因素影响的行为，如应用场所产生的行为或设计和制造产生的物理特性。 4.3 这种细胞培养试验方法适用于用于制造拟与组织、组织液或血液直接接触的医疗器械的材料的规范和标准。然而，当测试可吸收材料（包括洗脱或可降解涂层）、性质为液体或凝胶状、形状不规则的固体材料或具有高密度或质量的材料时，应小心，以确保该方法适用。如果试样中的浸出物能够通过琼脂层扩散，则应采用基于琼脂糖的方法，如试验方法 F895 可被视为一种替代方法，具体取决于样本特征，或在研究人员希望进一步评估测试样本下细胞的细胞毒性反应的情况下。

1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices. 1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared. 1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques. 1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F748 . 1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is a well characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 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. ====== Significance And Use ====== 4.1 This practice is useful for assessing 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 materials and medical devices. 4.2 This practice assumes that assessment of cytotoxicity potential provides one method for predicting the potential for cytotoxic or necrotic reactions to medical materials and devices during clinical applications to humans. In general, cell culture testing methods have shown good correlation with animal assays when only chemical toxicities are being considered. Note 1: The results obtained using this method may not predict in vivo behavior which can be influenced by multiple factors such as those arising from site of application or physical properties that may result from design and fabrication. 4.3 This cell culture test method is suitable for adoption in specifications and standards for materials for use in the construction of medical devices that are intended to have direct contact with tissue, tissue fluids, or blood. However, care should be taken when testing materials that are absorbable, include an eluting or degradable coating, are liquid or gelatinous in nature, are irregularly shaped solid materials, or have a high density or mass, to make sure that the method is applicable. If leachables from the test sample are capable of diffusing through the agar layer, agarose-based methods such as Test Method F895 may be considered as an alternate method, depending on sample characteristics, or in cases where investigators wish to further evaluate the cytotoxic response of cells underlying the test sample.