-
Products & Services
-
-
News & Events
-
Face mask
Product Details
The Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids.
MEDICAL FACE MASK TESTS AND REQUIREMENTS
U.S.A.:ASTM F2100-19 STANDARD SPECIFICATION FOR PERFORMANCE OF MATERIALS USED IN MEDICAL FACE MASKS
EUROPE:EN 14683:2019 MEDICAL FACE MASKS-REQUIREMENTS AND TEST METHODS
| ASTM F2100-19 | EN 14683:2019 Barrier Levels | ||||||
| Level 1 | Level 2 | Level 3 | Typel | Type ll | Type IIR | ||
| Barrier Testing | BFE% ASTM F2101,EN 14683 | ≥95 | ≥98 | ≥95 | ≥98 | ||
| PFE% ASTM F2299 | ≥95 | ≥98 | Not required | ||||
| Synthetic Blood ASTM F1862,IS022609 | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Not required | Pass at ≥16.0 kPa (>120 mmHg) | ||
| Physical Testing | Differential Pressure EN 14683 | <5.0mmH20/c㎡ | <6.0mmH2O/c㎡ | <40 Pa/c㎡ | <60 Pa/c㎡ | ||
| Safety Testing | Flammability 16 CFR Part 1610 | Class 1 (≥3.5 seconds) | See European Medical Directive (2007/47/EC,MDD 93/42/EEC) | ||||
| Microbial Cleanliness ISO 11737-1 | Not required | ≤30 cfu/g | |||||
| Biocompatibility ISO 10993 | 510 K Guidance recommends testing to ISO 10993 | Complete an evaluation according to ISO 10993 | |||||
| Sampling ANSI/ASQC Z1.4 ISO 2859-1 | AQL 4% for BFE,PFE,Delta P 32 masks for Synthetic Blood (Pass= ≥29 passing, Fail = ≤28 passing) 14 masks for Flammability | Minimum of 5 masks up to an AQL of 4% for BFE, Delta P and Microbial Cleanliness 32 masks for Synthetic Blood (Pass = ≥29 passing,Fail=≤28 passing) | |||||
Recommended Products
If you have more needs?
Welcome your message, we will reply you in time.
355 Longjin Road, Changzhou Economic Development Zone, Jiangsu Province, China
