Medical sterilization packaging bag is to put the instruments to be finally sterilized into the packaging bag. After sealing, the microorganisms on the equipment in the bag can be killed by physical or chemical methods, so that the equipment in the bag can remain sterile within the specified validity period. Specifically, it can include the following functions
—Adapting to the corresponding sterilization process;
-Protect the equipment in an acceptable state of use;
-It has bacteria barrier performance and can maintain the sterility and integrity of the instrument before use;
-Can be opened aseptically to use the instrument;
-Identify and use products correctly.
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software.
Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role.
The purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; Examination, substitution, adjustment or support of physiological structure or process; Support or sustain life; Pregnancy control; By examining human samples, information can be provided for medical or diagnostic purposes.
In terms of curative effect and expected effect, there is a certain gap with the definition of medical devices, which does not belong to medical devices.