Medical Surgical Face Mask

The classification of materials designed to protect against biological aerosols such as medical face masks and air filters is carried out according to EN 14683 in European norms. They are divided according to performance requirements as Type I, Type II and Type IIR. A similar classification has been made in the American norms. 

Type I medical face masks should only be used for patients and others, especially in epidemic or pandemic situations to reduce the risk of spreading infections. Type I masks are not intended for use by healthcare professionals in an operating room or other medical settings with similar requirements. You can contact us for the following tests. 

Surgical face masks must be sent as finished product when sending for performance testing. If it is desired to evaluate whether the materials are suitable for production, they can be sent in the form of a piece of material (10x10cm) for testing. 

Performance tests are carried out within the scope of TÜRKAK accreditation. 

Apart from the above performance tests, biocompatibility tests must be performed according to EN ISO 10993-1 standard for surgical face masks. Considering the place and time of contact with the body, it becomes necessary to perform physical and chemical evaluation, cytotoxicity, irritation and sensitization tests. Competent institutions should be preferred for these tests. 

Since there is a microbiological load limit for surgical face masks, it is necessary to create mask material and to produce (cutting, sewing, etc.) in controlled areas that meet these limits. 

When labeling the masks according to EN 14683, the medical device Directive 93/42 / EEC EK1-13 must be specified on the packaging in which the medical face scissors is provided, as well as the EN14683 number and the type of mask. 

For the CE certification process, certification companies authorized by TÜRKAK should be consulted and studies should be carried out accordingly.