Page 16 - CATALOGO MASCARILLAS QUIRÚRGICAS TIPO IIR

Page 7 of 12 Report No. 60377885 001

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

When a mask consists of two or more areas with Same characteristics and same N/A
different characteristics or different layer-composition, layer-composition declared by
each panel or area shall be tested individually. manufacturer.

The lowest performing panel or area shall determine See above N/A
the BFE value of the complete mask
5.2.3 Breathability P

When tested in accordance with Annex C, the See appended table 5.2.3 P
differential pressure of the medical face mask shall
conform to the value given for the relevant type in Table
1.
If the use of a respiratory protective device as face N/A
mask is required in an operating theatre and/or other
medical settings, it might not fulfil the performance
requirements with regard to differential pressure as
defined in this European Standard. In such case, the
device should fulfil the requirement as specified in the
relevant Personal Protective Equipment (PPE)
standard(s).
5.2.4 Splash resistance P

When tested in accordance with ISO 22609:2004 the See appended table 5.2.4 P
resistance of the medical face mask to penetration of
splashes of liquid shall conform to the minimum value
given for Type IIR in Table 1.

5.2.5 Microbial cleanliness (Bioburden) P
When tested according to EN ISO 11737-1:2018 the See appended table 5.2.5 P
bioburden of the medical mask shall be ≤ 30 CFU/g
tested (see Table 1).
5.2.6 Biocompatibility N/E
According to the definition and classification in EN ISO The biocompatibility is not N/E
10993-1:2009, a medical face mask is a surface device evaluated in this test report.
with limited contact.

The manufacturer shall complete the evaluation of the N/E
medical face mask according to EN ISO 10993-1:2009
and determine the applicable toxicology testing regime.
The results of testing should be documented according N/E
to the applicable parts of the EN ISO 10993 series.

The test results shall be available upon request. N/E
6 Marking, labelling and packaging P
Annex I, §13, of the Medical Devices Directive See attachment. P
(93/42/EEC) or Annex I, §23, of the Medical Device
Regulation (EU) 2017/745 specifies the information that
should be specified on the packaging in which the
medical face mask is supplied.
QMF-RT-33008SHG Revision number: 1.0 Effective date: 2020-03-12