本文件规定了注射用塑料容器的安全操作和物理、化学和生物试验的要求。本文件适用于具有一个或多个腔室且总标称容量在50毫升至5000毫升范围内的非肠道用塑料容器，例如直接注入（注射）溶液的薄膜袋或吹塑塑料瓶。注:在某些国家，国家或地区药典或其他政府法规具有法律约束力，这些要求优先于本文件。

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.