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BSI 23/30457006 DC 2023

BSI 23/30457006 DC 2023

$13.70

BS EN 14683. Medical face masks. Requirements and test methods

Published By Publication Date Number of Pages
BSI 2023 36
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PDF Catalog

PDF Pages PDF Title
1 30457006-NC.pdf
3 41_e_stf (4).pdf
8 1 Scope
2 Normative references
3 Terms and definitions
10 4 Classification
5 Requirements
5.1 General
5.1.1 Materials and construction
5.1.2 Design
11 5.2 Performance requirements
5.2.1 General
5.2.2 Bacterial filtration efficiency (BFE)
5.2.3 Breathability
5.2.4 Splash resistance
5.2.5 Microbial cleanliness (Bioburden)
12 5.2.6 Biocompatibility
5.2.7 Summary of performance requirements
13 6 Manufacturing and processing requirements and documentation
7 Marking, labelling and packaging
14 Annex A (informative) Information for users
A.1 Selection and use
A.2 Donning and doffing
15 Annex B (normative) Method for in vitro determination of bacterial filtration efficiency (BFE)
B.1 General
B.2 Principle
B.3 Reagents and materials
B.3.1 General
B.3.2 Tryptic soy agar
B.3.3 Tryptic soy broth
16 B.3.4 Peptone water
B.3.5 Culture of Staphylococcus aureus ATCC 6538, growing on tryptic soy agar slants.
B.4 Test apparatus
B.5 Test specimens
17 B.6 Preparation of bacterial challenge
B.7 Procedure
19 B.8 Calculation of bacterial filtration efficiency (BFE)
B.9 Test report
21 Annex C (normative)Breathability – Method for determination of the differential pressure
C.1 Principle
C.2 Test apparatus
22 C.3 Test specimens
C.4 Procedure
23 C.5 Calculation of differential pressure
C.6 Test report
25 Annex D (informative)Test procedure for microbial cleanliness
26 Annex E (informative)Rationales
E.1 General
E.2 Sizing of medical face masks
E.3 Leakage around the medical face mask
E.4 Shelf life determination
E.5 Why does the document only test the filter using bacteria rather than viruses?
27 E.6 Breathability as determined by the differential pressure
E.7 Where did the limits in this document come from?
E.8 Bypass leakage
28 E.9 Design
29 Annex F (informative)Transparent medical face masks
F.1 General
F.2 Breathability
F.3 Differential pressure measurement of TMFM
30 F.4 Particle attenuation
F.5 Filtration measurement of TMFM
F.6 Fit
F.7 Function
F.8 Condensation
F.9 Acoustics
31 F.10 Durability
F.11 References
32 Annex G (informative)Environmental impact
34 Annex ZA (informative)Relationship between this European Standard and General Safety and Performance Requirements of Regulation (EU) 2017/745 [OJ L 117] aimed to be covered

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BSI 23/30457006 DC 2023
$13.70