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医疗器械生物学评价 第 11 部分:生物降解:试验选择、评价与结果解读

Guidance on the assessment of biocompatibility of biomaterials: Fundamentals and testing considerations.

机构信息

Faculty of Dentistry, National University of Singapore, Singapore; ORCHIDS: Oral Care Health Innovations and Designs Singapore, National University of Singapore, Singapore.

Dental Biomaterials, Dentistry, The University of Manchester, Manchester, United Kingdom.

出版信息

Dent Mater. 2024 Nov;40(11):1773-1785. doi: 10.1016/j.dental.2024.07.020. Epub 2024 Aug 10.

DOI:10.1016/j.dental.2024.07.020
PMID:39129079
Abstract

BACKGROUND

Assessing the biocompatibility of materials is crucial for ensuring the safety and well-being of patients by preventing undesirable, toxic, immune, or allergic reactions, and ensuring that materials remain functional over time without triggering adverse reactions. To ensure a comprehensive assessment, planning tests that carefully consider the intended application and potential exposure scenarios for selecting relevant assays, cell types, and testing parameters is essential. Moreover, characterizing the composition and properties of biomaterials allows for a more accurate understanding of test outcomes and the identification of factors contributing to cytotoxicity. Precise reporting of methodology and results facilitates research reproducibility and understanding of the findings by the scientific community, regulatory agencies, healthcare providers, and the general public.

AIMS

This article aims to provide an overview of the key concepts associated with evaluating the biocompatibility of biomaterials while also offering practical guidance on cellular principles, testing methodologies, and biological assays that can support in the planning, execution, and reporting of biocompatibility testing.

摘要

背景

评估材料的生物相容性对于确保患者的安全和健康至关重要,可以防止不良的、有毒的、免疫的或过敏的反应,并确保材料在一段时间内保持功能而不会引发不良反应。为了进行全面评估,必须精心规划测试,仔细考虑材料的预期应用和潜在暴露场景,以选择相关的测定法、细胞类型和测试参数。此外,对生物材料的组成和特性进行描述可以更准确地了解测试结果,并确定导致细胞毒性的因素。准确报告方法和结果有助于研究的可重复性,并使科学界、监管机构、医疗保健提供者和公众能够理解研究结果。

目的

本文旨在概述评估生物材料生物相容性的关键概念,同时提供关于细胞原理、测试方法和生物学测定法的实用指导,这些方法可以支持生物相容性测试的规划、执行和报告。

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