ULTRASONIC MASK PRODUCTION
TRN MODA, who wants to carry its experience in the field of ready-to-wear to the field of medical textile products, started to produce sterile and non-sterile disposable surgical masks under the TRN MedTeks brand in its own facility established in an additional 2000 m2. Medical surgical masks are divided into two main groups, Type I and Type II, depending on the bacteria filtration efficiency. Medizinische Operationsmasken werden in Abhängigkeit von der Effizienz der Bakterienfiltration in zwei Hauptgruppen unterteilt, Typ I und Typ II. It is named Type II or Type IIR according to its splash resistance.
There are separate requirements for each type.
TRN MedTeks, has a daily production capacity of 1 million Type IIR surgical masks, by providing all medical production standards demanded by medical institutions.
Medical surgical face masks are designed to be used in operating rooms , or in the areas which the healt services are given with similar requirements to medical environments and to protect whole working environment .
The EN 14683 standard defines two types of medical surgical face masks with associated levels of protection.
As a minimum, Type I medical face masks are used for patients to reduce the risk of spreading infections in the community, especially in epidemic or pandemic situations.
Type II masks are primarily designed for use by healthcare professionals in an operating room or other medical areas with similar requirements of operating rooms.
EN 14683 Performance tests are ; In vitro evaluation of bacteria filtration efficiency (BDE), air permeability (differential pressure), microbial cleaning, splash resistance according to ISO 22609: 2004 standard (for Type IIR masks) and biocompatibility tests.
Regarding microbial cleaning, the biological burden of our masks in our production; it has been evaluated according to Annex D of the ISO 14683 standard or according to the EN ISO 11737-1 standard. In addition, our masks have been tested according to EN ISO 10993-1 standard and evaluated with clinical requests.
Considering the place and time of contact with the body, it becomes necessary to perform physical and chemical evaluation, cytotoxicity, irritation and sensitization tests.
Ultrasonic surgical masks, also known as three-layer surgical masks, are medical products that must be produced according to certain standards and our company has ISO 13485 and CE certificates.
The main features of the masks we produce are as follows :
The entire mask is produced using 3-layer PP non-woven fabric. There is a wire on the nose that allows it to fit properly to the face.
The elastic strips are developed to fit all faces
The fabric weight is 75 grms.