SAFE COMFORT REUSABLE 5-LAYER PROFESSIONAL FACE MASK
• Material: Non woven fabric, polypropylene, 5-layers with different density/thickness/texture
• Bacterial Filtration Efficiency: Test BFE 99,9% exceed ISO Standard Annex B (BFE=98%)
• Differential Pressure / Breathability: Test 53,9 Pa/cm2 exceed <60 Pa/cm2 / Type IIR Annex C
• Microbic Cleanless: Test 12 cfu/g Bioburden exceed ISO EN 11737-1:2018 Annex D - <30 ufc/g
• Blood Splash Resistant: = 16,0 (kPa) Type II R, EN 14683 Annex C
• Reusable No.: X times (upon care when used)
• Machine washable: 40°C-35' (Test BFE 99,9% after 5 wash)
• Disinfectable: - With alcool spray (isopropanol) No. X times - In microwave oven max 1’ - 700W No. X times
• Autoclavable: In thermo-pouch at 121°C-28’ (Test BFE 99,9% after 20 cycles)
• Conform to normative: UN I EN 14683:2019 Type IIR; ISO EN ISO 10993-1-5-10-12-18; ISO EN 11737-1:2018; ISO 22609:2005
TECNICAL SPECIFICATIONS
• Material: Non woven fabric, polypropylene, 5-layers with different density/thickness/texture
• Bacterial Filtration Efficiency: Test BFE 99,9% exceed ISO Standard Annex B (BFE=98%)
• Differential Pressure / Breathability: Test 53,9 Pa/cm2 exceed <60 Pa/cm2 / Type IIR Annex C
• Microbic Cleanless: Test 12 cfu/g Bioburden exceed ISO EN 11737-1:2018 Annex D - <30 ufc/g
• Blood Splash Resistant: = 16,0 (kPa) Type II R, EN 14683 Annex C
• Reusable No.: X times (upon care when used)
• Machine washable: 40°C-35' (Test BFE 99,9% after 5 wash)
• Disinfectable: - With alcool spray (isopropanol) No. X times - In microwave oven max 1’ - 700W No. X times
• Autoclavable: In thermo-pouch at 121°C-28’ (Test BFE 99,9% after 20 cycles)
• Conform to normative: UN I EN 14683:2019 Type IIR; ISO EN ISO 10993-1-5-10-12-18; ISO EN 11737-1:2018; ISO 22609:2005
- Classe Medicale
- I
- Dispositivo Medico
- Dispositivo medico
- unità
- 1 pz.
- NSIS
- 1963473
- CND
- T020601