Medical masks, which are subject to the Medical Devices Regulation, must meet the requirements of the "TS EN14683 + AC: 2019" standard. At the same time, the CE mark showing that it complies with this standard and the Medical Devices Regulation should be visible on the product.
Medical masks are defined as "Class I" in the "Medical Devices Regulation". In order to be put on the market, it must meet all the requirements in the "TS EN 14683 + AC: 2019" standard.
"TS EN 14683 standard" defines the performance requirements of the product and the features it should have. One of these features is the biological load that the product should have.
The "bioburden level", which is referred to as "microbial cleaning" in the standard, is carried out according to the "EN ISO 11737-1" standard.
For medical masks produced according to TS EN 14683 standard, the number of bioburden (microbial cleaning) should be at most 30 cfu/g. All medical masks must meet this standard.
© 1994 | Saniter Gıda – Çevre Bilimi Gözetim Ve Mühendislik Hiz. Tur. Tic. A.Ş.