Test cost for sterility inspection report of medical mask
Medical mask sterility inspection reporting agency "CCIC Huatongwei"
21 years of testing experience, supporting nationwide inspections
Mask test hotline 400-963-0755
Mail box： roy.yi@szhtw.com.cn
Let me explain for you
What is the difference between a sterile mask and a non-sterile mask? It is divided into sterilization type and microbial limit index, that is, packaging with a "sterilization" or "non-sterilization" label should be sterile,
Non-sterile masks refer to masks that have not been sterilized. Each product has undergone strict quality inspection-microbiological indicators: not detected, and according to the current state of sterility management of medical devices, SAL (Sterile Assurance Level) must reach the sixth power of 10.
The main reason for sterile masks is that the items that need to be entered in medical places (such as ICUs and operating rooms) that need to strictly control the microbial environment are sterile and will not cause other bacterial infections to patients.
Domestic: The method in Appendix B of GB 15979-2002 "Disposable Hygiene Products" is usually used to detect the microbial content in non-sterile masks, and GB/T 14233.2-2005 "Test Methods for Medical Infusion, Blood Transfusion and Injection" equipment Part 2: "Biological Test Method", used to detect the content of microorganisms in sterile masks;
Abroad: There is no difference between sterile masks and non-sterile masks. For example, Europe adopts EN 14683: 2019 + AC: 2019 Annex D to reflect the microbial content in masks by measuring bioburden.
EN 14683: 2019 + AC: 2019 Bioburden Test
Result judgment: the bioburden of the mask ≤30 CFU/g
China's medical device testing chooses CCIC Huatongwei
Test steps:
1. Randomly select 5 masks, put them in an Erlenmeyer flask, and pour 300mL extract;
2. Place the Erlenmeyer flask in a constant temperature shaker and shake at 250 rpm for 5 minutes;
3. Take 100 ml of the above extraction solution, filter and clamp the filter disc, and then connect it to the TSA and SDA plates. The TSA plate was incubated at 30°C for 3 days, and the SDA plate was incubated at 20°C to 25°C for 7 days.
4. Count the number of colonies on the TSA plate and the SDA plate.