ISO/TS 16775:2014为ISO 11607-1和ISO 11607-2中包含的要求提供了指导。它不会增加或以其他方式改变ISO 11607 - 1和/或ISO 11607 - 2的要求。这是一份非规范的资料性文件，不包括作为监管检查或认证评估活动基础的要求。 该指导可用于更好地了解ISO 11607-1和/或ISO 11607-2的要求，并说明了满足这些国际标准要求的各种方法和方法。不需要使用它来证明它们的合规性。 给出了评估，选择和使用包装材料，预制无菌屏障系统，无菌屏障系统和包装系统的指南。还提供了关于成型，密封和组装过程验证要求的指导。 ISO/TS 16775:2014提供卫生保健设施和医疗器械行业的信息。包装材料和系统打开后，不提供指导。在使用包装用于其他目的，例如“无菌场”或运输受污染物品时，将适用其他监管标准

ISO/TS 16775:2014 provides guidance for the application of the requirements contained in ISO 11607‑1 and ISO 11607‑2. It does not add to, or otherwise change, the requirements of ISO 11607‑1 and/or ISO 11607‑2. It is an informative document, not normative, and does not include requirements to be used as basis of regulatory inspection or certification assessment activities. The guidance can be used to better understand the requirements of ISO 11607‑1 and/or ISO 11607‑2 and illustrates some of the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required to be used to demonstrate compliance with them. Guidelines are given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given. ISO/TS 16775:2014 provides information for health care facilities and for the medical devices industry. It does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a "sterile field" or transport of contaminated items, other regulatory standards will apply.