The packaging design of medical devices must be able to ensure both the compliance of the inner packaging materials and the safety under the condition that it meets its purpose. In this article, the P & G packaging team has collected relevant cultural standards, which can be used as a reference for machinery enterprises to verify product packaging materials. Yy/t 068.1, yy/t 0313, yzb/ national product registration standard, EN868-1, gb/t 16886.5-2003, etc.

The compatibility between packaging materials and medical devices should mainly consider the following points:

1. toxicological safety of packaging materials;

2. physical and protective requirements for the size and shape of packaged medical devices;

3. sensitivity of medical devices to special hazards, such as radiation, moisture, mechanical impact and electrostatic radiation;

Taking the medical blister box packaging as an example, starting from the fact that the material can provide physical, chemical and microbial protection, the following two points should be considered:

1. under normal use conditions, the blister boxes before, during and after sterilization shall not release substances known to be toxic and harmful to health.

2. ensure that the sterile state is maintained. After the medical device is sterilized, it becomes a sterile device until the product becomes invalid. The packaging material of the blister box must have complete microbial barrier.

On the whole, to evaluate the conformity of the packaging system through the packaging integrity verification of medical devices, the following items can be inspected by reference:

1. initial contaminating bacteria of packaging

2. bacterial resistance (such as peel strength test & agar contact attack test)

3. cytotoxicity

4. leakage test

5. complete package stacking test

6. extrusion strength test of outer packaging, etc.