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 至少部分地通过粘附到活组织起作用的材料和装置在外科手术中发现越来越多的用途，或者作为缝合线和钉的辅助物，或者作为这些装置在各种各样的医疗手术中的直接替代物。虽然所涉及的力的性质和大小随适应症和患者特定情况而有很大变化，但所有用途在某种程度上都涉及材料抵抗所施加的机械力的能力。因此，材料的机械性能，特别是粘合性能，是评价其适用性的重要参数。此外，给定粘合剂组合物的机械性能可以提供用于质量控制的确定产品一致性的有用手段，或者作为用于确定各种表面特性的影响的手段。在使用装置之前在衬底上进行处理。 4.2 即使在单个指示用途（外科手术）内，组织粘合剂装置的单个应用的复杂性和多样性使得T-剥离测试的结果不适合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。 4.3 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 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures, either as adjuncts to sutures and staples or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient-specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control, or as a means for determining the effects of various surface treatments on the substrate prior to use of the device. 4.2 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 T-peel test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors. 4.3 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.