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本指南提供了试验方法概要。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本指南不评估待包装的产品；使用的灭菌方法；或通过灭菌、分配和处理的包装性能。 1.5以国际单位制表示的数值应视为标准值。 括号中给出的值是英寸-磅单位的数学转换，仅供参考，不被视为标准值。 ====意义和用途====== 本设计和评估指南描述了评估软医疗包装和包装材料的七个类别。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、加工和油墨性能。 本设计和评估指南旨在评估所有七个类别，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。 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。 必须考虑所有七个类别的适用性。 医疗包装设计和评估的测试方法总结（图1）提供了本指南中引用的测试方法的紧凑图形表示。 测试说明和适用性 （见表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。 包装设计:材料特性和结果包装的评估 — 这被称为 “ R & D评估 ” 在表1中。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。 包装合规性:常规监测是否符合规范 — 这被称为 “ 合规性测试 ” 在表1中。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。 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的封装性能。填充的包装必须在使用条件下进行评估。 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。 导轨F 99 或F 2559 可能会提供有用的指导。

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. 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; the sterilization method to be used; or package performance through sterilization, distribution, and handling. 1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard. ====== Significance And Use ====== This design and evaluation guide describes seven categories for evaluating flexible medical packages and packaging materials. These include safety, barrier properties, durability, package and seal integrity, visibility and appearance, processing, and printing ink properties. The intent of this design and evaluation guide is to evaluate all seven 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. Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition. All seven categories must be considered for applicability. 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. Test Description and Applicability (see Table 1): Table 1 lists the test methods commonly used to evaluate flexible medical packaging. The test methods are used in two phases. 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. 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. 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. 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 F 99 or F 2559 may provide useful guidance.