1.1 本规程涵盖了一种非特异性急性毒性试验，用于检测医疗器械材料中的浸出物。 1.2 注射到小鼠体内的液体是通过实践获得的 F619 提取载体为盐水、植物油或其他模拟人体体液的液体。 1.3 概述了两种程序:方法A用于静脉注射，方法B用于腹腔注射。 1.4 本规程是为评估材料的生物相容性而开发的几种规程之一。实践 F748 可为特定应用的材料测试方法的选择提供指导。 1.5 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。 1.6 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。 1.7 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 本规程旨在帮助评估医疗器械中使用的材料的生物相容性。这是一种急性毒理学试验，旨在检测有害浸出物质的存在。 4.2 这种做法可能不适用于所有类型的植入应用。鉴于所测试的材料、其潜在应用以及实践中包含的建议，用户应谨慎考虑该方法的适当性 F748 . 4.3 唯一适用的限制是提取物制备。 参考实践第4.3节和第4.4节 F619 有关此限制的描述。

1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices. 1.2 The liquids injected into the mouse are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids. 1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection. 1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 intended to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances. 4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748 . 4.3 The only limitation applicable is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description of this limitation.