FAQs PPE – Technical Compliance – Medical Face Masks

FAQs PPE – Technical Compliance To Relevant Performance Standards For Medical Face Masks

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Standard Test TitleReference StandardMinimum acceptable performance levelCompliant  Claimed performance (Class, Type, or measured)Year/Version of standardReference document (.pdf)
   YESNo   
Test report origin 
ILAC accredited labISO 17025Compliant           
National Notifying BodyISO 17025Compliant           
Local, non-accreditedISO 17025Compliant           
Whole mask performance 
Materials used in medical face masksASTM F2100Level 1           
ASTM F2100Level 2           
ASTM F2100Level 3           
Requirements and test methods for medical face masksEN 14683Type I           
EN 14683Type II           
EN 14683Type IIR           
Surgical mask (fluid resistant)YY 0469Compliant           
Single-use medical face maskYY/T 0969Compliant           
Physical performance/characteristics 
Droplet Filtration efficiency (3.0 μm particle size)ASTM F210195% AQL 4%, RQL=20%           
ASTM F210198% AQL 4%, RQL=20%           
Droplet Filtration efficiency (3.0 μm particle size)YY 046995% AQL 4%, RQL=20%           
YY 046980 mmHg AQL 4%, RQL=20%           
Droplet Filtration efficiency (3.0 μm particle size)YY/T 0969120 mmHg AQL 4%, RQL=20%           
YY 0469160 mmHg AQL 4%, RQL=20%           
Filtration efficiency (0.1 μm particle size)ASTM F2299 Class 1 AQL 4%, RQL=20%           
Synthetic blood penetrationASTM F186295% AQL 4%, RQL=20%           
98% AQL 4%, RQL=20%           
95% AQL 4%, RQL=20%           
Flammability16 CFR Part 161080 mmHg AQL 4%, RQL=20%           
Biocompatibility  –           
Number of layersMinimum 3           
Basis weightASTM D3776 –           
shelf life  5 years            
Comfort characteristics 
Differential pressureMIL-M-36945C 4.4.1.1.1 Method 1 or EN14683˂3.0 mm H2O/cm2, 29.4 Pa/cm2            
˂4.0 mm H2O/cm2, 39.2 Pa/cm2             
˂5.0 mm H2O/cm2, 49.0 Pa/cm2           
Quality compliance 
General quality management systemISO 9001Compliant           
Medical device quality managementISO 13485Compliant           
Sampling procedures for inspection by attribute, post shipmentISO 2859Compliant           
Regulatory clearance 
EU PPE Regulation 2016/425 Valid, issued <5 years           
EN MD Directive 93/42/EEC Valid, issued <5 years           
US FDA 510(k) Valid, issued <5 years           
NMPA, export clearance Valid, issued <5 years           
NMPA, internal use Valid, issued <5 years