生物安全评估是为了美国卫生工程师协会(asse)ss whether a product is safe for its intended use depending on its composition. For example, an evaluation of a cardiovascular implantable device would need to assess potential risks associated with long term contact with blood and vascular tissue.
ISO 10993-1:2018, and the associated guidance document from the Food and Drug Administration (FDA), provides a framework for biological safety evaluations using biological endpoint assessments for new or modified medical devices.1Devices are categorized by their type of contact with the body – whether surface, externally communicating, or implantable devices. Additionally, they are categorized by their duration of contact – whether they have limited, prolonged or long term contact.
These documents help to guide the necessary steps in biological endpoint testing and assessments in biocompatibility evaluations.2作为此过程的一部分，有必要考虑设备加工和构建所涉及的所有材料的安全以及潜在的污染物。
可能构成生物相容性评估一部分的测试类型包括chemical characterizationin a study designed to simulate or exaggerate the clinical use case, or in vitro and in vivo biological testing.
Biological Endpoints
需要评估的生物终点取决于暴露的性质和持续时间。这些终点可以包括细胞毒性，刺激性，致敏，全身毒性，热原性，血液相容性，植入，遗传，遗传毒性，致癌性以及生殖和发育毒性。这些终点可以通过现有数据，与临床用例相关的合理性或通过对设备的新测试来解决。
Localized endpoints, such as cytotoxicity, irritation, or hemocompatibility, are those which correspond to a localized tissue response. Such endpoints typically require in vitro or in vivo biological testing. In contrast, systemic endpoints, such as genotoxicity, systemic toxicity, and carcinogenicity, may be addressed through chemical characterization and toxicological risk assessment. Certain endpoints, such as sensitization and pyrogenicity, result from a systemic physiological response, but are commonly addressed through biological testing. These endpoints may require a combination of in vitro testing and chemical characterization with predictive toxicological assessments in order to avoid in vivo testing for regulatory or ethical reasons.
作为生物相容性评估的一部分，也必须考虑有关单个孤立材料的信息是否真正代表完成设备中的材料。由于暴露于不同的环境或处理，可能会发生材料特性的变化。此外，设备中存在多种材料类型的存在可能会导致“混合效应”，应在强大的生物相容性评估中考虑。
在ISO 10993系列标准系列的各个子部分以及经合组织指南，USP章节和ASTM方法中，概述了解决所需端点的体外和体内生物测试方法。建议对专家指导的参与进行评估，以评估生物安全终点，尤其是在选择现有安全数据的测试和理由方面。
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- FDA (2022) Biocompatibility Evaluation Endpoints by Device Category, https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/biocompatibility-evaluation-endpoints-device-category, accessed May 2022
- FDA (2022) ISO 10993-1,https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and, accessed May 2022
