Medical Device Bag Material Test

Publisher: Administrator Date:2022-05-30

 
 

Applicable Products  
Plant materials, dressing, cotton swabs, implanted medical equipment, sterile equipment, etc.  
Medical materials are packaged in appearance, material, structure, manufacturing, etc., which may directly or indirectly affect the quality of medical equipment in the packaging, which will affect the safety of terminal users.  
For example, the commercially available medical equipment needs to be a sterile dress, cotton swab, phlegm tube, etc., and this type of medical material needs to be transported by packaging or packaging. In order to withstand the conditions such as transportation and environment. During the storage period of the shelves, the sterile state in the packaging can still be maintained, and it can maintain its durability and safety when the terminal user is to the terminal user.  
Detection standard  
Medical equipment aging simulation test (Accelerated Aging Study Astm F1980)  

 
Burst Test for Packaging ASTM F1140)  
The packaging of packaging material (Creep Test for Packaging ASTM F1140F)  
Packaging dye penetration test (Dye Penetration Study Astm F 1929)  
Sterility test iso 11737-2)  
Microbial Ranking, DIN 58953-6, ASTM F1608)  
Seal Peel Test for Packaging, ASTM F88)  
Packaging complete test (Bubble Test for Packaging ASTM F2096)  
Reliability test  
Packaging test service (EN 868 Series)  
other else  
Medical packaging material test process:  
Most of the packaging materials tests are nothing more than aging simulation tests, packaging materials blasting \\u0026 slowing tests, pyramid penetration tests, sterile tests, and microbial penetration tests. Now, let's briefly introduce each test method:  
Aging simulation test  
The aging simulation test is mainly to improve the temperature and shorten the storage time, so as to simulate the storage period claimed by the simulation product. And according to the formula in ASTM F1980, the corresponding simulation time is calculated at the temperature of the temperature. Storage of the sample, and then remove the subsequent experiments after the time is over.  
Packaging Blasting \\u0026 Slowing Test  
First quickly inflatable the bag material and observe how much the pressure of this bag is destroyed by the pressure of the package. This is a blasting test. After that, the pressure of N value of 80% was inflated and maintained for 30 seconds. After observing whether this package is destroyed during 30 seconds, if it can be greater than this time, it can be determined that this packaging material can be threatened by slowing the test.  
Paper Dyeing Trial Test  
After the dye is poured into the packaging material, it flows to the four edges, and then observes the situation of the four edges of the edge to leak to the edge of the edge to confirm the integrity of the packaging material.  
Sterile test  
Take out the sample in the bag for aseptic test to confirm whether the sample is sterile. If the sample is sterile, it means that there is no problem with the sterile barrier of the packaging material; if the sample is non -sterile, it means that the packaging material may have an opening during the storage period and cause the sterile packaging to be destroyed.  
Microbial penetration test  
This test mainly wants to look at the ability of packaging materials to shield microorganisms.  
CopyRight © 2022 Dongguan Gosun Electronic Precision Technology Co., Ltd. All Rights Reserved.    粤ICP备17051568号