1.1 本指南定义了柔性屏障材料的要求和注意事项。 1.2 本指南阐述了柔性阻隔材料的一些关键印刷要求。 1.3 本指南提供了拟作为辊料采购的柔性屏障材料的规范要求和注意事项。 1.4 如果打算以预制无菌屏障系统的形式购买柔性屏障材料，则指南 F2559 应参考。 1.5 以国际单位制表示的数值应视为标准值。国际单位制后括号中给出的值仅供参考，不被视为标准值。 1.6 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户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。 1.7 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《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 柔性屏障材料广泛用于各个行业，由无数供应商生产。它们可以是单层材料或复杂的复合结构。然而，即使材料多种多样，所有柔性屏障材料仍应具备基本要求。 5.2 柔性屏障材料要求可分为两类，即初始材料鉴定和常规生产和接收要求，以确保买方收到准确的订单。虽然书面规范中可能包含所有要求，但可能只需要在第一份订单之前进行初步鉴定测试。 每个订单都应遵守常规生产和接收要求。在适用的情况下，每一条款都注明了初始资格要求。 5.3 本指南提供了对柔性屏障材料制造、采购和验收所需要求的理解。还引用了适当的符合性测试方法。 注1: 由于特定或独特的情况，不得引用特定要求的所有试验方法。有关适用方法的更多指导，请参阅指南 F2097 . 5.4 规范及其要求应由产品的供应商和买方共同商定。这有助于确保柔性屏障材料符合规定的要求。

1.1 This guide defines the requirements and considerations for flexible barrier materials. 1.2 This guide addresses some critical printing requirements for flexible barrier materials. 1.3 Guidance is provided on specification requirements and considerations for flexible barrier materials intended to be purchased as rollstock. 1.4 If the flexible barrier material is intended to be purchased in the form of a pre-made sterile barrier system, Guide F2559 should be referenced. 1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard. 1.6 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. 1.7 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 Flexible barrier materials are universally used across industries and produced by a myriad of suppliers. They may be monolayer materials or complex composite structures. However, even with the diversity of material, there are still basic requirements that all flexible barrier materials should exhibit. 5.2 Flexible barrier material requirements may be divided into two categories, initial material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements may be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated with each clause, where applicable. 5.3 This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of flexible barrier materials. Appropriate test methods for compliance are also cited. Note 1: All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097 . 5.4 The specification and its requirements should be mutually agreed to by the supplier and purchaser of the product. This helps ensure that the flexible barrier materials will comply with the specified requirements.