1.1 本规范规定了设计、性能、文件和标签要求，并提供了用于防止接触液体化疗和其他液体危险药物的防护服的试验方法。 1.1.1 本规范的主要要求是防护服阻挡材料和接缝对七种化疗药物的特定电池的渗透阻力测试。为满足这七种液体化疗药物的A部分标签要求，制定了两级防护服屏障材料和接缝性能。 1.1.1.1 广泛的化疗药物保护是基于防护服屏障材料和接缝，证明突破检测时间为30 对于七种指定的化疗药物而言，为分钟或更长。 1.1.1.2 选择性化疗药物保护基于防护服屏障材料和接缝，显示突破检测时间为30 对于七种特定化疗药物中的至少五种而言。 1.1.2 还可以报告制造商或最终用户组织确定的其他液体化疗药物和其他感兴趣的液体危险药物的渗透阻力测试结果，这些药物使用符合B部分标签要求的单个药物的相同突破检测标准。 1.1.3 符合本规范的防护服还需要满足最低可燃性要求，如果用作医疗器械，则需要符合生物相容性要求（如果用于破损的皮肤接触），如果在使用前已灭菌，则需要证明无菌保证。 1.1.4 可选择报告表明防护服强度、耐久性和透气性的物理特性。 1.1.5 为符合本规范的防护服提供的标签和用户信息制定了附加要求。 1.1.6 本规范还要求用作医疗器械的产品，如手术衣和隔离衣，以满足AAMI PB70规范的相应要求 F2407/F2407米 、和规范 3352米/3352米 ，如适用。 1.2 本规范不涉及在液体化疗和其他危险药物的制造、运输、配制、制备和给药过程中穿戴防护服的个人的所有暴露条件，以及患者护理活动和遇到这些药物污染物品的泄漏情况。 1.3 本规范不涉及可能以蒸气或气雾剂形式遇到的化疗药物或危险药物，也不提供任何呼吸保护标准。 1.4 本规范不涉及液体化疗或其他液体危险药物防护服的选择、使用或护理。虽然本规范未具体确定选择哪种屏障材料，但本规范中所述的试验结果可通过比较不同材料的试验结果来选择屏障材料。有关选择、使用和护理个人防护设备以保护医护人员免受化疗或其他有害药物伤害的具体指南，请参见USP 800《医疗保健环境中的有害药物处理》。 1.5 本规范旨在为制造商或供应商提供具体声明的依据，即防护服产品可防止液体化疗和其他液体危险药物。 1.6 以国际单位制或其他单位表示的值应单独视为标准值。每个系统中规定的值必须独立使用，不得以任何方式组合值。 1.7 本标准并不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建立适当的安全、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（TBT）委员会发布的《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。

1.1 This specification establishes design, performance, documentation, and labeling requirements and provides test methods for protective clothing used in preventing exposure to liquid chemotherapy and other liquid hazardous drugs. 1.1.1 The principal requirement of this specification is permeation resistance testing of the protective clothing barrier material and seams to a specified battery of seven chemotherapy drugs. Two levels of protective clothing barrier material and seam performance are established for complying with Part A labeling requirements specific to these seven liquid chemotherapy drugs. 1.1.1.1 Broad chemotherapy drug protection is based on the protective clothing barrier material and seams demonstrating breakthrough detection times of 30 min or more for the seven specified chemotherapy drugs. 1.1.1.2 Selective chemotherapy drug protection is based on the protective clothing barrier material and seams demonstrating breakthrough detection times of 30 min or more for at least five of the seven specified chemotherapy drugs. 1.1.2 It is also possible to report permeation resistance test results for additional liquid chemotherapy and other liquid hazardous drugs of interest as determined by the manufacturer or end user organization using the same breakthrough detection criteria for individual drugs for complying with the Part B labeling requirements. 1.1.3 Protective clothing meeting this specification is also required to meet minimum flammability requirements, and if used as a medical device, biocompatibility (if used for breached skin contact), and demonstrate sterility assurance, if sterilized prior to use. 1.1.4 Physical properties that indicate the strength, durability, and breathability of the protective clothing are optionally reported. 1.1.5 Additional requirements are established for the label and user information to be provided for protective clothing meeting this specification. 1.1.6 This specification also requires products intended to be used as medical devices such as surgical gowns and isolation gowns to meet the respective requirements of AAMI PB70, Specification F2407/F2407M , and Specification F3352/F3352M , as applicable. 1.2 This specification does not address all conditions of exposure for individuals who wear protective clothing in the manufacture, transport, compounding, preparation, and administration of liquid chemotherapy and other hazardous drugs in addition to patient care activities and spills where contaminated items with these drugs are encountered. 1.3 This specification does not address chemotherapy drugs or hazardous drugs that may be encountered in the form of a vapor or aerosol and does not provide any criteria for respiratory protection. 1.4 This specification does not address the selection, use, or care of protective clothing used for protection against liquid chemotherapy or other liquid hazardous drugs. While this specification does not specifically determine which barrier material to select, the results of the tests described in this specification are useful for selecting barrier materials by comparing the test results among different materials under consideration. See USP 800, Hazardous Drugs—Handling In Healthcare Settings, for specific guidelines on the selection, use, and care of personal protective equipment for protection of healthcare workers against chemotherapy or other hazardous drugs. 1.5 This specification is intended to provide the basis for manufacturers or suppliers to make specific claims that protective clothing products provide protection against liquid chemotherapy and other liquid hazardous drugs. 1.6 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way. 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.