Surgical mask stability testing (CE mark)

C

ciccina

Starting to get Involved
Hi all!
I am supporting a company in obtaining the CE mark for surgical masks. The masks are three layers of non-woven fabric. In relation to stability of the product I have seen that some competitors set an expiration date of 5 years while in other cases I found nothing about it on the labeling.
What is the approach in these cases? What kind of stability tests have to be done?

Thank you in advance for any tips and advice!!!!
 
M

monoj mon

Trusted Information Resource
I don't have any experience with surgical masks. But, I am just wondering, will it be appropriate to conduct package integrity testing along with the performance testing after a certain point of accelerated aging (say after 1 year, 3 years & 5 years) within the expected shelf life (say 5 years) just like other medical devices!
 
SKM.Sunil

SKM.Sunil

Involved In Discussions
ciccina said:
Hi all!
I am supporting a company in obtaining the CE mark for surgical masks. The masks are three layers of non-woven fabric. In relation to stability of the product I have seen that some competitors set an expiration date of 5 years while in other cases I found nothing about it on the labeling.
What is the approach in these cases? What kind of stability tests have to be done?

Thank you in advance for any tips and advice!!!!
Click to expand...


Please go through following standards, which may help you. (y)
EN 149+A1 September 2009
EN 14683:2014
 
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