1.1 本指南为医疗产品初级柔性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。必须根据要包装的特定产品的相关特性以及测试、研发或合规性的目的来选择特定的单独测试方法。并非所有测试方法都适用。 1.3 本指南不涉及可接受性标准，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。 1.6 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。其中包括安全性、屏障、材料和包装性能属性和特性、包装完整性、可见性和外观、加工、印刷油墨、分布模拟和调节。 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，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测试方法提供了一种途径，用于评估包装设计和监测包装合规性。 注1: 本指南中包含的许多标准都是美国食品药品监督管理局（FDA）认可的共识标准。 选择和使用美国食品药品监督管理局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。欲了解更多信息，请访问美国食品药品监督管理局标准和合格评定计划https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program 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）和产品成分。 4.4 必须考虑所有类别的适用性。 4.5 医用包装设计与评价试验方法综述( 图1 )提供了本指南中引用的测试方法的紧凑图形演示。

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. 1.6 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 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning. 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 Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program 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.