1.1本指南为医疗产品主要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。

1.1 This guide provides directions for the design and evaluation of primary 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.