YY/T 0698.1-2011 in English

YY/T0698的本部分规定了最终灭菌医疗器械包装用吸塑包装共挤塑料膜的要求和试验方法。本标准适用于在医疗器械厂对医疗器械进行吸塑包装的共挤塑料膜。
本部分未对ISO11607-1的通用要求增加要求,这样,4.2至4.5中的专用要求可用以证实符合ISO11607-1的一项或多项要求,但不是其全部要求。
由吸塑膜和其他包装材料组成医疗器械无菌屏障系统,能使使用者在打开包装前看到内装物,以便于无菌操作。

Scope

This part of YY/T 0698 specifies the requirements and test methods for co-extruded plastic films for blister packaging for final medical device packaging (hereinafter referred to as "blister films"). This standard applies to co-extruded plastic films used for blister packaging of medical devices in medical device factories. This section does not add requirements to the general requirements of ISO 110607-1, so that the specific requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more requirements of ISO 11607-1, but not all of its requirements. The medical device sterile barrier system is composed of blister film and other packaging materials, which allows users to see the contents before opening the package to facilitate aseptic operation.