1.1 本规程提供了一种用于评估用于制造与血液接触的医疗器械的材料的溶血性能的方案。 1.2 本实践旨在评估急性 体外 与血液接触的材料的溶血特性。 1.3 本规程包括静态条件下材料提取物或材料与血液直接接触的溶血试验方案。建议进行两种试验（提取和直接接触），除非材料应用或接触时间证明有理由排除其中一种试验。 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。试验方法 E2524 提供了一种使用减少试验体积来评估接触血液的纳米颗粒材料的溶血特性的方案；这可能包括脱离材料表面的纳米颗粒。 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和健康实践，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====== 5.1 与血液接触的溶血物质的存在可能会导致红细胞的损失或损害，并可能产生游离血浆血红蛋白水平升高，能够诱导毒性作用或可能对肾脏或其他器官造成压力的其他作用。 5.2 这种做法可能无法预测在所有类型的植入应用过程中发生的事件。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 .

1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to evaluate the acute in vitro hemolytic properties of materials intended for use in contact with blood. 1.3 This practice consists of a protocol for a hemolysis test under static conditions with either an extract of the material or direct contact of the material with blood. It is recommended that both tests (extract and direct contact) be performed unless the material application or contact time justifies the exclusion of one of the tests. 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. Test Method E2524 provides a protocol using reduced test volumes to assess the hemolytic properties of blood-contacting nanoparticulate materials; this may include nanoparticles that become unbound from material surfaces. 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 and health 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 ====== 5.1 The presence of hemolytic material in contact with the blood may cause loss of, or damage to, red blood cells and may produce increased levels of free plasma hemoglobin capable of inducing toxic effects or other effects which may stress the kidneys or other organs. 5.2 This practice may not be predictive of events occurring during 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 .