1.1 本规程涵盖了评估医用手套材料在连续接触条件下对潜在危险的癌症化疗药物渗透的耐受性的方案。基于九种化疗药物在一定时间内通过手套材料的渗透（突破）进行评估。 1.2 需要强调的是，本评估中使用的条件旨在近似临床使用的最坏情况。在比较手套材料时，数据应限制在相对基础上使用。 1.3 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。 1.4 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====== 4.1 本规程的目的是提供一个统一的程序来评估医用手套材料对化疗药物渗透的耐药性，并建立一致的测试数据报告。

1.1 This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time. 1.2 It is emphasized that the conditions used in this assessment are intended to approximate the worst-case condition for clinical uses. The data should be restricted to use on a relative basis when comparing glove materials. 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 objective of this practice is to provide a uniform procedure for assessing the resistance of medical glove materials to permeation by chemotherapy drugs, and to establish a consistent reporting of the test data.