Page 15 - CATALOGO MASCARILLAS QUIRÚRGICAS TIPO IIR

Page 6 of 12 Report No. 60377885 001

EN 14683:2019+AC:2019
Clause Requirement + Test Result - Remark Verdict

4 Classification P
Medical face masks specified in this European Type IIR P
Standard are classified into two types (Type I and Type
II) according to bacterial filtration efficiency whereby
Type II is further divided according to whether or not
the mask is splash resistant. The 'R' signifies splash
resistance.
5 Requirements P

5.1 General P
5.1.1 Materials and construction P
The medical face mask is a medical device, generally 3 ply designed with two layers of P
composed of a filter layer that is placed, bonded or polypropylene spunbonded non-
moulded between layers of fabric. woven fabric and one layer of
polypropylene melt-blown non-
woven fabric.

The medical face mask shall not disintegrate, split or P
tear during intended use.
In the selection of the filter and layer materials, P
attention shall be paid to cleanliness.
5.1.2 Design P
The medical face mask shall have a means by which it P
can be fitted closely over the nose, mouth and chin of
the wearer and which ensures that the mask fits closely
at the sides.
Medical face masks may have different shapes and With nose clip P
constructions as well as additional features such as a
face shield (to protect the wearer against splashes and
droplets) with or without anti-fog function, or a nose
bridge (to enhance fit by conforming to the nose
contours).
5.2 Performance requirements P

5.2.1 General P
All tests shall be carried out on finished products or P
samples cut from finished products.

5.2.2 Bacterial filtration efficiency (BFE) P
When tested in accordance with Annex B, the BFE of See appended table 5.2.2 P
the medical face mask shall conform to the minimum
value given for the relevant type in Table 1.
For thick and rigid masks such as rigid duckbill or cup Not such mask. N/A
masks the test method may not be suitable as a proper
seal cannot be maintained in the cascade impactor. In
these cases, another valid equivalent method shall be
used to determine the BFE.
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12