1.1 膝后（BTK）方法以人类志愿者的腘窝为测试点，同时评估基质和产品的固有化学刺激和潜在机械刺激，这些基质和产品被设计为与皮肤反复或长时间密切接触（见验证参考资料 ( 1- 7. ) ). 2. 这是一种双边试验，将试验材料与具有已知安全特性的参考材料进行比较。 1.2 该测试方法应由具有良好临床实践（GCP）程序经验的合格医疗保健专业人员使用。 1.3 这种测试方法可以使用受试者在完整或受损的皮肤上进行。对于预期与正常、完整皮肤接触的测试基质或产品，或与具有已知皮肤刺激性的产品进行直接比较，应在完整皮肤上进行测试。 可以在受损皮肤上进行测试，以确定测试基质或产品是否通常会接触受损皮肤（例如，尿布疹皮肤或皮肤干裂）或预期会水合的皮肤。 1.4 红斑和干燥的视觉评分由经过训练的皮肤分级机在预定的量表上进行。 1.5 在本试验中使用之前，材料应按照方案实践中概述的方法进行总体良好的生物相容性测试 F748美元 或ISO 10993-1:2009。作为本系列测试的一部分，根据实践进行刺激 功能719 或ISO 10993-10。 1.6 以英寸磅为单位的数值应视为标准。本标准不包括其他计量单位。 1.7 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 本试验方法旨在评估预期与皮肤接触的产品和材料的固有化学刺激和机械刺激的组合。 这是一种比较方法，将测试材料的潜在刺激性与形式和成分相似的参考材料的潜在激励性进行比较。参考材料应具有已知的安全性和刺激性。

1.1 The behind-the-knee (BTK) method, using the popliteal fossa of human volunteers as a test site, simultaneously evaluates the inherent chemical irritation and the potential for mechanical irritation of substrates and products that are designed to come into repeated or extended close contact with the skin (see validation references ( 1- 7 ) ). 2 This is a bilateral test comparing a test material to a reference material with a known safety profile. 1.2 This test method shall be used by qualified health care professionals experienced in good clinical practice (GCP) procedures. 1.3 This test method can be performed using human subjects on either intact or compromised skin. Testing should be performed on intact skin for test substrates or products expected to have contact with normal, intact skin, or for direct comparison to products with a known skin irritation profile. Testing can be performed on compromised skin for test substrates or products that may commonly come into contact with damaged skin (for example, skin with diaper rash, or chapped skin) or skin that is expected to be hydrated. 1.4 Visual scoring of erythema and dryness is performed by a trained skin grader on a predefined scale. 1.5 Prior to use in this test, materials shall undergo overall favorable biocompatibility testing consistent with the approach outlined in protocol Practice F748 or ISO 10993-1:2009. As a part of this series of testing, irritation per Practice F719 or ISO 10993-10 shall be conducted. 1.6 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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. 1.8 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 ====== 5.1 This test method is intended to assess a combination of inherent chemical irritation and mechanical irritation for products and materials expected to come into contact with the skin. It is a comparative approach whereby the potential irritation of a test material is compared to that of a reference material similar in form and composition. The reference material should have a known safety and irritation profile.