1.1 本试验方法旨在提供一种用于比较软组织上用作外科粘合剂或密封剂或两者的组织粘合剂的粘合强度的方法。在适当选择基底的情况下，其还可用于基于组织粘合剂的医疗装置的制造中的质量控制目的。 1.2 以SI单位表示的值将被视为标准值。本标准不包括其他计量单位。 1.3 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.4 本国际标准是根据《关于制定国际标准、指南和准则的原则的决定》中确立的国际公认的标准化原则制定的世界贸易组织技术性贸易壁垒（TBT）委员会发布的表彰。 ======意义和用途====== 4.1 粘合剂在临床医学中的用途、范围和功效在文献中有很好的记录。无论是用作粘合剂、止血剂、密封剂，还是药物或生长因子的载体，或两者兼而有之，粘合剂在临床医学中的使用范围不断扩大。有几个因素对医用组织粘合剂的成功和功效至关重要，包括:（ 1 ）足够的组织结合强度，（ 2 ）组织相容性，（ 3 ）当粘合剂内部使用时可接受的生物降解性能，（ 4 ）可用性，（ 5 ）易于应用，以及（ 6 ）成本。 4.2 医用粘合剂目前用于多种应用和组织类型。应用范围从外部组织的固定到与相似或不同的相对表面一起使用的内部应用。虽然粘合剂的生物或化学组成或两者可以限定其特性，但是包括粘合剂体积或施加方法或两者的附加机械因素也可以显著地促进粘合剂的性能。为了公平和充分地量化医用粘合剂的粘合强度，制定一致、可重复的测试标准以用于评估和比较目的非常重要。由于粘合剂将用于活体组织上或活体组织中的事实，优选容易获得的生物测试表面。 4.3 从生物组织的标准化测试方法产生的数据可能与发现的数据不同 体内 然而，测试结果应提供关于潜在粘合能力的有价值的信息，并为后续的准备提供有价值的信息 体内 实验。 4.4 组织粘合剂装置的单个应用的复杂性和多样性，甚至在单个指示用途（外科手术）内，使得拉伸测试的结果不适合于在没有对应用和粘合剂行为进行彻底分析和理解的情况下确定允许的设计应力。 4.5 该测试方法可用于比较粘合剂或粘合工艺对疲劳和环境变化的敏感性，但必须非常谨慎地进行此类比较，因为不同的粘合剂可能对不同的条件做出不同的响应。

1.1 This test method is intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of tissue adhesive based medical devices. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 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. 1.4 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 utility, range, and efficacy of adhesives in clinical medicine are well documented in the literature. Whether being used as an adhesive, hemostatic, sealant, or carrier for drugs or growth factors, or both, the scope of adhesive use in clinical medicine continues to expand. There are several factors which are vital to the success and efficacy of a medical tissue adhesive, including: ( 1 ) adequate tissue bonding strength, ( 2 ) tissue compatibility, ( 3 ) acceptable biodegradable properties when the adhesive is used internally, ( 4 ) availability, ( 5 ) ease of application, and ( 6 ) cost. 4.2 Medical adhesives are currently used for a variety of applications and tissue types. Applications range from fixation of external tissues to internal application for use with either similar or dissimilar opposing surfaces. While the biological or chemical makeup, or both, of the adhesive may define its characteristics, additional mechanical factors including adhesive volume or method of application, or both, may also contribute significantly toward the performance of the adhesive. In an effort to fairly and adequately quantify adhesive bonding strength for medical adhesives, it is important to develop a consistent, reproducible testing standard for evaluative and comparative purposes. Due to the fact that the adhesives will be used on or in living tissues, a readily available biological testing surface is preferred. 4.3 The data generated from a standardized testing method on biologic tissue may vary from that found in vivo , however, testing results should offer valuable information on the potential bonding capacity and for the preparation of subsequent in vivo experiments. 4.4 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure), is such that the results of a tensile test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors. 4.5 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.