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Medical face mask or respirator
What you should know about the use of medical face masks and respirators.


What is a medical face mask?

A medical face mask is a loose fitting, disposable mask that covers the nose and mouth. This includes products labelled as surgical, dental, medical procedures, insulation, mouth and nose protection, and laser masks.

Medical face masks help prevent droplets from spreading through the person wearing them. They also keep splashes off the mouth and nose of the person wearing the face mask. They are not intended to protect the wearer from inhaling tiny particles. Face masks should only be used once and then discarded.

What is a respirator?

A respirator is designed to protect you from inhaling very small particles that can contain viruses. This type of respirator fits snugly against the face which means that most of the air is inhaled through the filter material. In order for the mask to work best, a respirator should be fitted to each person (this is known as a “fit test” and is usually done in a workplace where respirators are used).

Some healthcare workers, such as nurses and doctors, use this type of respirator when treating patients with diseases that can be airborne.

What you should know that when using medical face masks and respirators!

European standard

What you should know that when using medical face masks and respirators!

European standard

1.EN 14683 (Medical face masks - Requirements and test methods)

Introduction:
The transmission of infectious agents during surgery in operating theatres and other medical facilities can occur in a number of ways. Sources include the noses and mouths of the surgical team. The main purpose of surgical masks is to protect patients from infectious agents from the noses and mouths of staff and to protect the wearer from splashes of potentially contaminated liquids in certain situations.

Scope of application:
This European Standard specifies design, performance requirements and test methods for medical face masks which are intended to limit the transmission of infectious agents from
staff to patients and (in certain situations vice versa) during surgery in operating theatres and other medical facilities with similar requirements. This European Standard is not applicable to masks which are intended for the personal protection of personnel.

Classification:
The medical face masks specified in this standard are classified into two types according to bacterial filtration efficiency and differential pressure, and each type is further classified according to whether the masks are splash-proof or not.

TestType IType IIType II R
Filter effectiveness for bacteria (BFE), (%)≥ 95≥ 98≥ 98
Breathing resistance (Pa / cm²)< 40< 40< 60
Splash resistance pressure (kPa)Not applicableNot applicable≥ 16
Microbiological purity (KBE/g)≤ 30≤ 30Typ I≤ 30

COMMENT: Type II R is a liquid-resistant type


Medical Face Mask Performance Requirements:

Labelling and information must be given:
Annex 1 of the Medical Device Regulation EU 2017/745 specifies the general requirements for medical devices and the information that must be given on the packaging in which the surgical mask is supplied.

Include the following information:
a) The number of this European Standard.
b) The type of mask (as indicated in the table).

2.EN 149 (European standards for filtering disposable respirators)

Scope of application:
This European Standard specifies design and performance requirements and test methods for filter respirators for protection against solid aerosols or oil-based particles.

Classification:
EN 149 divides particle protection into the following categories: FFP1, FFP2, FFP3

Requirements
Penetration of filter mediaBreathing resistance (mbar)
Sodium chloride 95 l / minParaffin oil 95 l / minInhaleExhaleExhale


30 l/min95 l/min160 l/min
20%20%0,62,13
6%6%0,72,43
1%1%133+





Labelling and information must be given:
Include the following information:

  1. Identification of the manufacturer or the responsible supplier.
  2. Protection classes: FFP1, FFP2 or FFP3.
  3. Number of the standard and year of publication.
  4. Year of the end of the storage period.
  5. Recommended storage conditions.
  6. Instructions for use must be given with every smallest commercially available packaging.
  7. Identification number at the body that carried out the EU type examination.

Which case? Which mask?

View of the requirements:

Directive on personal
protective equipment FFP (EN149)
Personal protective equipment
US-Norm N95
Medical devices directive
Surgical mask (EN 14683)
Filtering efficiency
–Sodium chloride
Filtering efficiency
–Sodium chloride
Filtering efficiency
Bacteria
Filtering efficiency
–Paraffin oil
Total inward leakageTotal inward leakage
Breathing resistance
Re-breathed CO2
Breathing resistance
Breathing resistance
Fluid penetration
No bacterial filtration efficiencyNo bacterial filtration efficiency
No filter effect against paraffin oil
Inhalation protection
is not taken into account

Surgical masks are not personal protective equipment.

Regular surgical masks are not certified as protection against airborne diseases. Surgical masks are not designed to be used as particulate respirators and do not provide as much protection as a respirator. Surgical masks do not prevent leakage from the edge of the mask when the user inhales. About 60% - 90% of the particles get round the edge of the mask.

Products should comply with the guideline (s) that cover the “principal intended use” of the product

  1. Protection of the patient: Medical devices directive
  2. Per protection of the wearer: Personal protective equipment directive
  3. In certain situations to protect the wearer from splashing liquids: Medical devices directive

Wearing the DACH high-risk mask as protection against airborne diseases

The DACH High-Risk-Mask is a respirator specially designed for medical use.

The DACH High-Risk-Mask is personal protective equipment that is certified according to EN149: 2001 FFP3 and especially intended for medical use.

The DACH High-Risk-Mask has a very high filtration efficiency (99.47%) and an extremely low breathing resistance (even lower than an FFP1 breathing apparatus).

EN 149 requirementsTest results DACH high-risk mask

FFP1FFP2FFP2
Penetration of filter media (sodium chloride)20 %6 %1 %0,025%
Breathing resistance (mbar)



Inhalation (30 l/min)0,60,710,38
Inhalation (95 l/min)2,12,431,2
Exhalation (160 l/min)3331,95

The DACH high risk mask achieved the best results in a test arranged by a designated body.

Using a respirator

You must wear the respirator correctly. You will not be protected if you do not wear the respirator correctly. Follow the manufacturer's instructions.

Check before use: Check the respirator for defects

  1. Check the face piece for cuts, tears, fraying, or loss of elasticity.
  2. Check for damaged or missing hardware.
  3. Check the elasticity of the headbands.

Put on the respirator

  1. Unfold the mask into a bowl shape.
  2. Place the lower half under your chin.
  3. Pull the elastic band behind your head.
  4. Place the lower band around the neck. Place the upper band on the back of the head above the ears and adjust so that it exerts even pressure at every point.
  5. Use both hands to press the nasal clip against your nose to seal the area around your nose.
  6. Fit test: Hold the mask with both hands and exhale strongly. If there are leaks, change the position of the mask slightly and adapt it to the shape of the face.

Removing a respirator if ...

  1. Significant increase in breathing resistance.
  2. The respirator collapses due to excess moisture.
  3. The employee feels (smells / tastes) a breakage.
  4. The respirator is visibly soiled or damaged.
  5. The respiratory protection mask no longer seals against the face of the user.
  6. When leaving the patient room (followed by hand hygiene).
Particulate matter
Health risks and protective measures