1.1 本指南描述了可用于测量电池和表面之间形成的粘合剂强度以及分离粘附在基板上的电池所需的力的协议。控制哺乳动物细胞与表面的相互作用是开发安全有效的医疗产品的基础。本指南不包括表征表面的方法。这些方法产生的信息可用于获得表面对细胞附着敏感性的定量测量以及细胞对表面粘附的测量。本指南还强调了细胞培养史的重要性和细胞类型的影响。 1.2 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。 1.3 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 细胞附着或缺乏细胞附着到生物材料是影响器械或植入物性能的关键因素。细胞附着是一个复杂的、依赖时间的过程，涉及细胞的显著形态变化和细胞外基质的沉积。例如，Pierres等人（2002）审查了形成的粘合剂的细节 ( 4. ) ，Lukas和Dvorak（2004） ( 5. ) 和Garcia and Gallant（2003） ( 6. ) . 这种耦合的强度可以通过监测电池与基板之间的附着力来确定，也可以通过测量电池粘附后分离所需的力来确定。 4.2 细胞粘附到表面取决于一系列生物和物理因素，包括培养历史、细胞年龄、细胞类型以及下表面的化学和形态和时间。在制定测试协议时需要考虑这些因素。 4.3 由于两种细胞中的任何一种细胞都有可能附着在不同的基质上，因此设计稳健的方法来测量细胞附着在不同基质上的倾向更为复杂 粘附 或 分离 可以评估。这些过程并不总是相似或互补的。 4.4 大多数关于细胞附着的研究侧重于获得分离或脱粘已粘附到表面的细胞所需的时间依赖性力（James等人，2005） ( 7. ) . 最近，研究人员开始测量附着过程中细胞与下表面之间产生的粘附力（Lukas和Dvorak，2004） ( 5. ) . 从实用角度来看，测量从表面分离或脱粘细胞所需的力要比测量附着过程中产生的力容易得多。然而，在这两种情况下，应根据测量的预期用途谨慎地解释实验数据。本文所述的测量细胞粘附力的方法是测量分离粘附细胞所需的力。 4.5 本指南旨在概述当前的通用测试方法，并确定影响细胞粘附和分离评估的关键因素。预计本指南将成为制定一系列标准的基础，这些标准将更详细地描述这些测试方法。

1.1 This guide describes protocols that can be used to measure the strength of the adhesive bond that develops between a cell and a surface as well as the force required to detach cells that have adhered to a substrate. Controlling the interactions of mammalian cells with surfaces is fundamental to the development of safe and effective medical products. This guide does not cover methods for characterizing surfaces. The information generated by these methods can be used to obtain quantitative measures of the susceptibility of surfaces to cell attachment as well as measures of the adhesion of cells to a surface. This guide also highlights the importance of cell culture history and influences of cell type. 1.2 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. 1.3 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 Cell attachment or, lack of it, to biomaterials is a critical factor affecting the performance of a device or implant. Cell attachment is a complicated, time-dependent, process involving significant morphological changes of the cell and deposition of a bed of extracellular matrix. Details of the adhesive bond that is formed have been reviewed by, for example, Pierres et al (2002) ( 4 ) , Lukas and Dvorak (2004) ( 5 ) , and Garcia and Gallant (2003) ( 6 ) . The strength of this coupling can be determined either by monitoring the force of attachment between a cell and a substrate over time or by measuring the force required to detach the cell once it has adhered. 4.2 Cell adhesion to a surface depends on a range of biological and physical factors that include the culture history, the age of the cell, the cell type, and both the chemistry and morphology of the underlying surface and time. These elements need to be considered in developing a test protocol. 4.3 Devising robust methods for measuring the propensity of cells to attach to different substrates is further complicated since either cell adhesion or detachment can be assessed. These processes are not always similar or complementary. 4.4 Most studies of cell attachment focus on obtaining some measure of the time-dependent force required to detach, or de-adhere, cells that have already adhered to a surface (James et al, 2005) ( 7 ) . More recently investigators have begun to measure the adhesive forces that develop between cells and the underlying surface during attachment (Lukas and Dvorak, 2004) ( 5 ) . From a practical point of view, it is much easier to measure the force required to detach or de-adhere cells from a surface than to measure those that develop during attachment. However, in both cases, the experimental data should be interpreted with a degree of caution that depends on the intended use of the measurements. The methods of measuring cell adhesion described herein are measures of the force required to detach an adherent cell. 4.5 The purpose of this guide is to provide an overview of current generic test methods and identify the key factors that influence the assessment of cell adhesion and detachment. It is anticipated that this guide will form the basis for producing a series of standards that will describe these test methods in more detail.