1.1 本规程有助于评估心血管装置材料诱导血栓形成的能力。通过在材料表面活化后被血栓消耗时人类血小板和白细胞的减少来评估血栓的形成。根据ANSI/AAMI/ISO 10993-4，该试验可能是接触人类血液的设备和材料的血液相容性评估的一部分。另见测试方法 F2382 . 1.2 在执行本规程的过程中，应遵守所有安全政策和规程。所有人体血液和任何与人体血液接触的材料应装在生物危害袋中，正确标记内容物，并通过适当方式处理。 1.3 根据疾病控制中心/国立卫生研究院出版物《微生物和生物医学实验室的生物安全》（BMBL）中的建议，人类血液的处理应达到2级生物安全水平（BSL-2）。 献血者必须检测出乙型肝炎病毒（HBV）和人类免疫缺陷病毒（HIV）呈阴性。血液应与任何患者血液一样处理，并使用标准预防措施进行处理/操作。 注1: 其结果 体外试验 测试可能与实际的人类反应不一致。 1.4 以SI（国际单位制）单位表示的数值应视为标准值。本标准不包括其他计量单位。 1.5 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。 第节给出了一些具体的危害说明 8. 关于危险。 1.6 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 本规程的目的是通过比较暴露于试验材料的血液中的血小板和白细胞计数与未暴露于试验材料的对照血液中的血细胞计数来确定是否发生血栓形成。大量血小板和白细胞被包裹/合并在粘附在材料上的血栓中，其在血液中的计数会减少。心血管医疗器械不应使用致血栓材料，除非该器械的目的是促进血栓形成。

1.1 This practice assists in the evaluation of cardiovascular device materials for their ability to induce thrombus formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by thrombus after activation on the material surface. This assay may be part of the hemocompatibility evaluation for devices and materials contacting human blood, as in accordance with ANSI/AAMI/ISO 10993–4. See also Test Method F2382 . 1.2 All safety policies and practices shall be observed during the performance of this practice. All human blood and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled with the contents, and disposed of by appropriate means. 1.3 The human blood should be handled at Biosafety Level 2 (BSL-2) as recommended in the Centers for Disease Control/National Institutes of Health publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL). The human blood donor must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses. The blood should be treated like any patient blood and handled/manipulated using standard precautions. Note 1: The results of this in-vitro test may not correspond to actual human response. 1.4 The values stated in SI (International System of Units) units are to be regarded as standard. No other units of measurement are included in this standard. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Some specific hazards statements are given in Section 8 on Hazards. 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. ====== Significance And Use ====== 4.1 The purpose of this practice is to determine if thrombus formation has occurred by comparing platelet and leukocyte counts in the blood exposed to the test material relative to the blood cell counts in the control blood that has not been exposed to the test material. A large number of platelets and leukocytes becoming entrapped/incorporated in thrombi adhering to the material will be reflected by a decrease in their counts in blood. Thrombogenic materials should not be used for cardiovascular medical devices, unless the purpose of the device is to promote thrombosis.