FAQs PPE – Gowns – Isolation – Surgical

FAQs PPE List – Gowns – Isolation – Surgical

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Gowns, Isolation – Surgical

 Europe (EN 13795)US (AAMI PB70, ASTM F3352, ASTM F2407)China (YY T/0506)
Water resistance (impact penetration) <4.5 g (AAMI Level 1) ≤ 1.0 g (AAMI Level 2 and 3) (AQL 4%, RQL=20% 
Water resistance (hydrostatic pressure)≥ 20 cm H2O (critical area, std performance) ≥ 100 cm H2O (critical area, high performance) ≥ 10 cm H2O (less critical area, std and high performance)≥ 20 cm (AAMI Level 2) ≥ 50 cm (AAMI Level 3) (AQL 4%, RQL=20%≥ 20 cm H2O (critical area, std performance) ≥ 100 cm H2O (critical area, high performance) ≥ 10 cm H2O (less critical area, std and high performance)
Viral penetration Pass (AQL 4%, RQL=20% (AAMI Level 4) 
Resistance to wet bacterial penetration≤ 2.8 IB (critical areas, std performance) ≤ 6.0 IB (critical areas, high performance) ≤ 2.8 IB (critical areas, std performance) ≤ 6.0 IB (critical areas, high performance)
Resistance to dry microbial penetration≤ 300 CFU (less critical areas, std and high performance) ≤ 300 CFU (less critical areas, std and high performance)
Cleanliness microbial≤ 300 CFU (all areas, std and high performance) ≤ 300 CFU (all areas, std and high performance)
Bursting strength (Dry)≥ 40 kPa (all areas, std and high performance) ≥ 40 kPa (all areas, std and high performance)
Bursting strength (Wet)≥ 40 kPa (critical areas, std and high performance) ≥ 40 kPa (critical areas, std and high performance)
Tensile strength (Dry)≥ 20 N (all areas, std and high performance)≥ 30 N≥ 20 N (all areas, std and high performance)
Tensile strength (Wet)≥ 20 N (crit. areas, std and high performance) ≥ 20 N (crit. areas, std and high performance)
Other criteria to consider Optional: – Water vapor transmission Rate (ASTM D6701) – Evaporative resistance (ASTM F1868, Part B)China (GB 38462) gown standard, in effect October 2020