From households to hospital premises, from public transport to shopping centres, and from offices to school, the use of surgical face masks have never been more important.
Surgical face masks are now mandatory in almost every setting; indoor or outdoor.
Certification of surgical or medical face masks is important as it indicates that a certain standard has been met to be safe.
It basically validates the authenticity, effectiveness and compliance of surgical masks.
Marking on Surgical Mask
The markings on the mask is indicative of its certification.
As a manufacturer of masks, you are duty bound to get them CE marked according to the guidelines of the World Health Organization and European Union.
For medical devices, such as surgical face masks and face shields, it is the responsibility of the manufacturer to produce quality products, and in compliance with the European Standard EN 14683.
EN 14683 is the European Standard that surgical face masks must comply to.
This standard is based on certain properties that guarantee the integrity and compliance of the said surgical face masks.
These properties include; Bacterial Filtration Efficiency (BFE), liquid resistance ( splash resistance in particular), breathability and microfiltration.
Although some surgical face masks provide a certain degree of protection against large airborne particles, they still cannot be considered as a part of PPE.
Disposable Face Mask Must Meet PPE Standards
A mask should comply with PPE regulations to be regarded as Personal Protective Equipment which are essential for frontline staff in the current pandemic.
Registration and approval of surgical face mask designs, product quality and manufacturing process varies and is in accordance with the company producing it.
Evaluating surgical face masks varies and does depend on the regulating authority of that particular country.
Nonetheless, the basis of evaluation stays the same.
Surgical Mask Factors
Certain factors such as:
- Bacterial Filtration Efficiency (BFE)
or Particulate Filtration Efficiency (PFE) - Breathability
- Microbial cleanliness (microfiltration)
- Blood penetration resistance
- Flammability
- Leakage
- Biocompatibility
are considered while evaluating the surgical face mask.
All the masks sold in the UK should be CE certified and be according to requirements set by the Medical Device Directive/Regulations (MDD/MDR).
Medical masks which are sterile undergo another check and mandate certificate if they have passed the sterility requirement set by the governing body.
Be Safer with a Medical Mask
This current pandemic has shocked and caused fear in the hearts of not just the general public but also health care providers.
One after the other, people are being tested positive.
Fear mongering is rife.
Even with five tier lockdowns, there are situations when the public has to leave home to get basic necessities.
People are worried about fake surgical masks being sold on the market, such is the fear of contracting the virus.
Everyone should exercise caution when purchasing face masks and wear the very best possible CE certified face masks available so that they can not only protect themselves but also the people around them.