features
Surgical masks are medical devices that are commonly used to prevent and limit the transmission of infectious agents during surgical procedures and other medical settings with similar requirements.
In pandemic situations, such as that caused by Covid-19, surgical masks can be used to reduce the emission of infectious agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms or a diagnosis of Covid-19, as well as other people who enter their environment. The main utility of surgical masks is to protect the community from infections that may be transmitted by their wearer.
Typology
Surgical masks are classified according to breathability (measured as differential pressure) and bacterial filtration efficiency (BFE), distinguishing Type I (BFE ≥ 95%) and Type II (BFE ≥ 98%). The BFE measures the effectiveness of a surgical mask in capturing aerosol droplets that may be emitted by healthcare professionals, or others who wear the mask. For its part, breathability measures the pressure difference required to pass air through the mask.
Type I masks should be used primarily by patients and affected persons, to reduce the risk of spreading infections, particularly in epidemic or pandemic situations. Type II masks are intended for use by healthcare professionals.
Type II masks are subdivided according to their resistance or not to splashes, with Type IIR being those resistant to splashes, blood and other biological fluids.
Type I | Type II | Type IIR | |
|---|---|---|---|
Bacterial filtration efficiency (BFE), (%) (Standard UNE-EN 14683: 2019 + AC: 2019) | ≥ 95 | ≥ 98 | ≥ 98 |
Differential pressure (Pa / cm2) (Standard UNE-EN 14683: 2019 + AC: 2019) | < 60 | < 40 | < 60 |
Splash resistance pressure (kPa) | – | – | ≥ 16.00 |
Microbial cleaning (cfu / g) | ≤ 30 | ≤ 30 | ≤ 30 |
Composition
Triple layer of microbiological protection.
Todas nuestras mascarillas fabricadas en Sevilla Daysan® están constituidas por la superposición de tres capas de tejido-no tejido (TNT) que garantizan la eficacia de filtración bacteriana, la presión diferencial, la limpieza microbiana y la resistencia a salpicaduras en el caso de las mascarillas quirúrgicas IIR. Las materias primas cuentan con la certificación del instituto de Estudios Textiles AITEX and the laboratory Leitat Technological Center that develops the microbiological and biocompatibility tests of the masks.
INTERNAL LAYER (face side)
Non-woven fabric (TNT polypropylene 100%) produced with SPUNBOND technology (25gr / m2)
This very soft layer has a protective function for the face.
Avoid direct skin contact with the intermediate filtration layer.
INTERMEDIATE LAYER (filter layer): barrier fabric
Non-woven fabric (100% polypropylene TNT) produced with MELTBLOWN technology (25gr / m2) and made of 1-3 micron diameter microfibers.
This layer has the function of blocking the entry of microbes and dust.
OUTER LAYER (world side)
Non-woven fabric (polypropylene TNT100%) produced with SPUNBOND technology (25gr / m2) with hydrophobic treatment.
This layer has the function of conferring hydro-repellency mechanical resistance to the mask avoiding penetration of droplets and aerosols.
3 layers of protection
certified by Aitex
EN 14683: 2019 + AC
Made in Spain
Rules and Regulations Daysan®
Daysan® surgical masks comply with the regulations established in:
- Royal Decree 1591/2009, of October 16, which regulates medical devices (PS)
- Council Directive 93/42 / EEC of June 14, 1993, relating to medical devices (as of May 26, 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council, of April 5, 2017, on medical devices; that repeals it)
In addition to the technical manufacturing regulations, Daysan® surgical masks comply with:
- Standard UNE - EN 14683: 2019 + AC 2019: Surgical masks. Requirements and test methods. This standard specifies the construction, design, performance requirement, and test methods of surgical masks intended to limit the transmission of infectious agents from medical personnel to patients during surgical procedures and other medium environments with similar requirements.
- ISO 22609: 2004 standard. For type IIR masks, which in turn sets the test standards regarding splash resistance.
Surgical masks are a health product (PS) and as manufacturers we have a facility operating license from the Spanish Agency for Medicines and Health Products (AEMPS).