ASTM International

Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
 N F2097

Annotation

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.

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.

This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.

This guide does not assess the product to be packaged or the sterilization method to be used.

The units cited in the referenced standard should be used.

Автоматический перевод:

Типичный гид для дизайна и оценки основной гибкой упаковки для лекарственных препаратов

Это руководство обеспечивает направления для дизайна и оценки основных гибких пакетов для лекарственных препаратов. Материалы пакета должны быть выбраны соответственно для производственного процесса, использования конца и упаковываемого продукта.