Medi-Laabs Dr Magdalena Laabs

High-quality Melt-Blown filter fabrics and raw materials for the production of hygienic masks, medical masks, FFP1, FFP2 and FFP3 half masks

Medi-Laabs Dr Magdalena Laabs
version de version pl

EU norms and regulations

EN 149:2004 + A1:2009

The FFP standards are mechanical filter standards used for protective respirator masks certified by the European Union . FFP-standard filters serve to protect against particulates such as dust particles , droplets, and aerosols The EN 149 standard defines three classes of filter efficiency, namely FFP , FFP2 and FFP3.

FFP filters are considered functionally equivalent to certain other filter standards regulated under other jurisdictions, such as N95 mask of the United States and KN95 filters of China. However, slightly different criteria are used to certify their performance, such as the filter efficiency, test agent and flow rate, and permissible pressure drop.

This article is about the European standards only. For information on other standards, on mechanica air filters in general, and the types of respirators which meet the FFP standards, see mechanical filter respirator. For more detailed information on items made to FFP standards, see the appropriate table below.

The EN 149 standard defines performance requirements for three classes of particle-filtering half masks: FFP1, FFP2 and FFP3. The protection provided by an FFP2 (or FFP3) mask includes the protection provided by a mask of the lower-numbered classes.

A mask conforming to the standard must have its class written on it, along with the name of the standard and its year of publication, as well as any applicable option codes, e.g. “EN 149:2001 FFP2 NR D”. Some manufacturers use in addition the colour of the elastic band to identify the mask class, however the EN 149 standard does not specify any such colour coding and different manufacturers have used different colour schemes.


Class

Filter penetration limit

(at 95 l / min air flow)

Inward leakage
Typical elastic bandi
FFP1
Filters at least 80%
<22%
Yellow
FFP2
Filters at least 94%
<8%
Blue or white
FFp3
Filters at least 99%
<2%
Red


EN 14683: 2019 + AC: 2019

EN 14683, a European standard, describes the requirements and testing methods of medical face masks. It’s most recent publication is EN 14683:2019+AC:2019 Medical face masks - Requirements and test methods.


The standard lays down guidelines in the design, production, performance requirements as well as test methods of medical face masks in order to limit contamination. It strictly regulates Bacterial Filtration Efficiency (BFE),


Breathability (Pressure Drop) and Microbial Cleanliness. Bacterial Filtartion Efficiency, the resistance of a material to bacterial/other microorganism penetration.It can be performed on masks and filtering media to evaluate the level of protection against biological aerosols. The main sources of contamination during operations are mounth, nasal cavities of the employees. During epidemics, it can prevent spreading of the infectious diseases.


EN 14683 standard performance tests includes tests for:

  • In vitro evaluation of bacterial filtration efficiency
  • Air permeability (differential pressure) test
  • Microbial cleanliness test
  • Splash resistance test under ISO 22609 standard (only for Type IIR masks)
  • Biocompatibility tests (optional)

The requirements are as follows:

Test
Type I
Type II
Type IIR
Bacterial filtering efficiency ≥95% ≥98% ≥98%
Differential pressure  <40 Pa/cm2 <60 Pa/cm2 <60 Pa/cm2
Splash resistance  -
-
At least 16,0 kPa
Microbial cleanliness  Up to 30 Cfu/g Up to 30 Cfu/g Up to 30 Cfu/g
The filtering efficiency and protective power of a face mask can be compromised when the mask is wet, torn or removed. Rule of thumg is the higher the protection value of a mask, the longer the filtering performance. Effective duration can change depending on User health condition, respiration, moisture, speech style

background-type-of-masks-medical-masks-disponible-masks