Standard Number: YY/T 0698.1-2011(YY/T0698.1-2011)
Chinese:最终灭菌医疗器械包装材料 第1部分：吸塑包装共挤塑料膜 要求和试验方法
English:Packaging materials for terminal sterilized medical devices.Part 1:Co-extrusion plastic films used for vacuum forming packaging.Requirements and test methods
Effective Date:2013-06-01
ICS:11.080.040
Standard Applicability:YY/T 0698 of this part specifies the final sterilization medical device packaging co-extruded plastic film (hereinafter referred to as “blister film”) requirements and test methods. This standard applies to medical devices in the medical device factory for medical device blister packaging co-extruded plastic film. This part does not add requirements to the general requirements of ISO 11607-1, so that the specific requirements in 4.2 to 4.5 can be used to confirm compliance with one or more of the requirements of ISO 11607-1, but not all of its requirements. A medical device aseptic barrier system consisting of blister film and other packaging materials enables the user to see the contents before opening the package to facilitate aseptic handling.
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