1.1本指南为医疗产品主要软包装的设计和评估提供了指导。包装材料必须根据制造过程、最终用途和包装产品进行适当选择。 1.2本指南提供了测试方法、实践和程序的概要。必须根据待包装特定产品的相关特性以及测试、研发或合规性的目的选择特定的单独测试方法。并非所有测试方法都适用。 1.3本指南不涉及验收标准，验收标准需要由包装生产商和医疗产品制造商共同确定。 1.4本指南不评估要包装的产品或要使用的灭菌方法。 1.5应使用参考标准中引用的单位。 ====意义和用途====== 4.1本设计和评估指南描述了评估柔性医疗包装和包装材料的多个类别。 这些包括安全性、阻隔性、耐久性、包装和密封完整性、可见性和外观、加工、油墨性能和包装性能。 4.2本设计和评估指南旨在评估所有引用的类别，并选择适用的类别。一旦对产品进行了表征并确定了灭菌方法，对任何特定包装都有许多要求。本设计和评估指南为评估这些要求和选择用于评估包装设计和监测包装合规性的测试方法提供了途径。 注1 — 本指南中包含的许多标准是美国食品和药物管理局（FDA）认可的共识标准。选择和使用美国FDA认可的共识标准是自愿的，用户在确定其适用性时全权负责。 有关更多信息，请访问美国FDA医疗器械标准计划http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm. 4.3产品特性应包括质量或重量、几何形状（长度和宽度、高度和形状）和产品组成。 4.4必须考虑所有类别的适用性。 4.5医疗包装设计和评估的测试方法总结( 图1 )提供本指南中引用的测试方法的紧凑图形表示。 4.6 测试说明和适用性 （参见 表1 ): 4.6.1 表1 列出了常用于评估医用软包装的测试方法。试验方法分两个阶段使用。 4.6.1.1 包装设计:材料特性和结果包装的评估- 这在中称为“研发评估” 表1 . 该阶段的测试特点是生成组件材料和包装组件性能的定量数据。 这些测试方法很长，不适用于需要快速响应以进行过程控制的制造环境。通常情况下，它们价格昂贵，需要医疗包装或设备制造设施无法提供的专用设备。 4.6.1.2 包装合规性:常规监测是否符合规范- 这在中称为“符合性测试” 表1 . 该阶段的测试必须快速、廉价，并且易于在制造环境中实施。目标不是开发设计数据，而是确保满足设计规范。这些测试方法不一定直接测量临界值，而是检测材料、工艺或产品中指示所有临界特性的变化。 4.6.2需要注意的是，没有任何单独的测试方法能够完全预测最终包装的性能。 填充的包装必须在使用条件下进行评估。 4.7一旦确定了包装和/或包装材料的设计，可能适合创建包装和/或材料规范。指南F99或F2559可能提供有用的指导。

1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged. 1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable. 1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer. 1.4 This guide does not assess the product to be packaged or the sterilization method to be used. 1.5 The units cited in the referenced standard should be used. ====== Significance And Use ====== 4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, printing ink properties, and package performance. 4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance. Note 1 — Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Medical Device Standards Program at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm. 4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition. 4.4  All categories must be considered for applicability. 4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation ( Fig. 1 ) provides a compact graphical presentation of the test methods referenced in this guide. 4.6 Test Description and Applicability (see Table 1 ): 4.6.1 Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases. 4.6.1.1 Package Design: Characterization of the Materials and Evaluation of the Resultant Package— This is referred to as “R&D Evaluation” in Table 1 . Testing during this phase is characterized by the generation of quantitative data on the performance of the component materials and the package assembly. These test methods are lengthy, making them inappropriate for the manufacturing environment where rapid response is required for process control. Often, they are expensive and require specialized equipment not readily available at a medical packaging or device manufacturing facility. 4.6.1.2 Package Compliance: Routine Monitoring of Adherence to Specifications— This is referred to as “Compliance Testing” in Table 1 . Testing during this phase must be rapid, inexpensive, and readily implemented in a manufacturing environment. The objective is not to develop design data, but to ensure that the design specifications are being met. These test methods do not necessarily make direct measurements of critical values, but detect variations in material, process, or product that are indicative of all critical characteristics. 4.6.2 It is important to note that no individual test method is entirely predictive of final package performance. Filled packages must be evaluated under conditions of use. 4.7 Once the design of the package and/or packaging materials has been determined, it may be appropriate to create a package and/or material specification. Guides F99 or F2559 may provide useful guidance.