Biocompatibility | ||||||
Descrpt. |
|
international test standard |
laboratory study # |
Results |
Comments | |
1 |
Cytotoxicity – Agar Overlay |
ISO10993 |
Nelson |
Pass |
No diffusable components that cause any harmful effects on animal cells | |
2 |
Irritation – primary skin |
ISO10993 |
Nelson |
Negligible irritant |
Causes no irritation when worn against the skin | |
3 |
Sensitisation – Buehler method |
ISO10993 |
Nelson |
no abnormal clinical signs |
causes no sensitisation when worn against the skin | |
Filtration of Micro-organisms and particulates | ||||||
Descrpt. |
|
international test standard |
laboratory study # |
Results |
Comments | |
4 |
Bacterial filtration |
EN14683 |
Nelson #477323 |
99.9% |
Filters > 99.9% of airborne bacteria | |
5 |
Viral filtration |
ASTM F2101 |
Nelson #477322 |
99.8% |
Filters 99.8% of airborne viruses | |
6 |
01 μm Latex Particulate filtrations |
ASTM F2299 |
Nelson #477326 |
97% @ 0.1 μm |
Filters particulates ≥ 0.1 microns such as dust mites, pet dander, pollen and air pollutants | |
Microbial – Contact kill rates of live pathogens | ||||||
Descrpt. |
|
international test standard |
laboratory study # |
Results |
Comments | |
7 |
Virucidal Efficacy Evaluation by direct contact kill |
ATCC CCL-34 |
Microbiotest #696-101 |
> 99.8% Human A- type Influenza Virus @ 2 Hours |
Test used to evaluate highest risk respiratory pathogen including H1N1 (swine flu) | |
Mask Physical performance parameters | ||||||
Descrpt. |
|
international test standard |
laboratory study # |
Results |
Comments | |
8 |
Fluid resistance |
EN14683 (ASTM 1862) |
Nelson #477327 |
pass @ 120 mmHg |
Achieves resistance against fluid splashes equivalent to an arterial spurt @ 120 mHg systolic blood pressure | |
9 |
Flammability |
16 CFR 1610 |
Nelson #477318 |
Class 1, no flame spread |
no flame spread | |
10 |
Breathability (differential pressure) |
EN14683 |
Nelson #477323 |
2.65 mm H2O/cm2 |
Based on FDA scale relating breathing resistance to comfort, a differential pressure drop of 2.0 to 3.0 is considered low |