FAQs PPE – Technical Compliance – Face Filtering Respirator

FAQs PPE – Technical Compliance To Relevant Performance Standards – Face Filtering Respirator

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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 NBISO 17025Compliant               
Local, non-accreditedISO 17025Compliant               
Whole respirator performance 
Europe RespiratorsEN 149FFP2               
EN 149FFP3               
US RespiratorsNIOSHN95               
NIOSHN99               
NIOSHN100               
NIOSHSurgical N95               
Korea RespiratorsKMOEL – 2017-641st Class               
China RespiratorsGB2626KN95               
GB 19083Grade 1               
Australia RespiratorsAS/NZA 1716P2               
Japan RespiratorsJMHLW-Notification 214DS               
Physical performance/characteristics 
Filter penetration of NaCl dry aerosol (at 95 L/min air flow)EN 149, Clause 7.9.2<6% (FFP2)               
<1% (FFP3)               
Filter penetration of paraffin aerosol (at 95 L/min air flow)EN 149, Clause 7.9.2<6% (FFP2)               
<1% (FFP3)               
Filter penetration of NaCl dry aerosol (at 30 L/min air flow)Filters >94% of NaCl particles of 2.5 μm<6%               
Filter penetration of NaCl dry aerosol (at 85 L/min air flow)NIOSH 42 CFR 84 (N95)>95% particle removal efficiency               
GB 19083 (Grade 1)>95% particle removal efficiency               
Total inward leakage (TIL)EN 149 Clause 7.9.1<11%, FFP2 < 8%, mean               
EN 149 Clause 7.9.1<5%, FFP3 2% (mean)               
CO2 in inhalation airEN 149 Clause 7.12<1%               
Synthetic blood penetration (Surgical N95)ASTM F186280 mmHg               
120 mmHg               
160 mmHg               
Synthetic blood penetration (FFP2 with fluid resistance)ISO 22609120 mmHg               
Synthetic blood penetrationGB 1908380 mm Hg               
Synthetic blood penetrationGB 19083 (Grade 1), reference (YY/T 0691-2008)Need test reference               
Flammability16 CFR Part 1610 Class 1               
EN 149, Clause 7.11< 5 seconds               
GB 19083, 4.10< 5 seconds               
Compatibility with skinEN 149, Clause 7.10 –               
GB 19083, 4.11Max score of 1               
shelf life*  5 years               
Comfort characteristics 
Breathing resistance (inhalation) @ 30 L/minEN 149, Clause 7.16Max 0.7 mbar (FFP2) 70 Pa               
Max 1.0 mbar (FFP3) 100 Pa               
Breathing resistance (inhalation) @ 95 L/minEN 149, Clause 7.16Max 2.4 mbar (FFP2) 240 Pa               
Max 3.0 mbar (FFP3) 300 Pa               
Breathing resistance (exhalation) @ 160 L/minEN 149, Clause 7.16Max 3.0 mbar (FFP2 and FFP3) 300 Pa               
Breathing resistance (inhalation/exhalation) @ 95 L/minEN 149, Clause 7.17.2.2Max 4 mbar, after clogging (FFP2)               
Breathing resistance (inhalation) @85 L/minSurgical N95Max 3.5 mbar 350 Pa               
GB 19083343.2 Pa               
Breathing resistance (exhalation) @85 L/minSurgical N95Max 2.5 mbar 250 Pa               
Breathing resistance @30 (inhalation) L/minKorea 1st Class (KMOEL – 2017-64)≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min)               
Breathing resistance (exhalation) @160 L/minKorea 1st Class (KMOEL – 2017-64)≤ 300 Pa               
Breathing resistance (inhalation) @85 L/minGB2626, KN95Max 350 Pa               
Breathing resistance (exhalation) @85 L/minGB2626, KN95Max 210 Pa               
Quality compliance 
General quality management systemISO 9001Compliance               
Medical device quality managementISO 13485Compliance               
Sampling procedures for inspection by attributeISO 2859Compliance               
Regulatory compliance 
Establishment licenceUS FDA databaseActive               
Listed as an acceptable respiratorNIOSHActive listing               
Listed as a non-NIOSH acceptable respiratorUS FDA Emergency Use AuthorizationActive listing               
Medical device license  US FDA databaseActive               
Medical Devices Active Licence ListingHealth Canada (MDALL)Active               
CE/EC certificationPPE Regulation 2016/425Compliance               
MHRAUKCompliance               
KOSHAKorea KMOEL – 2017-64Compliance               
Manufacturers allowed to exportNational Medical Products AdministrationActive licence/permit               
Manufacturers cleared for local saleNational Medical Products AdministrationActive licence/permit