External Test Reports

Lanaco has submitted its Helix™ Filter material to multiple external test houses to gain compliance under various respiratory and health standards.


AS/NZS 1716 for Respiratory Protective Devices

This standard specifies requirements, performance and testing criteria for the manufacture of respiratory protective devices (respirators) intended to provide protection against atmospheres containing substances that may be harmful if breathed and atmospheres that may be deficient in oxygen.

Independent Lab: INSPEC, UK

Sample Submitted: A complete face mask that uses a Helix™ Filter.

Results: The Helix™ Filter complies to a P2 level (>94% efficiency) and has an incredibly low breathing resistance (34 Pa average).

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Particle Filtration Efficiency (PFE) according to ASTM F2299

The PFE test evaluates the filtration efficiency of filter media by challenging the filter with a known dosage and size of latex particles. The latex particles generated are in the sub-micron size range and can simulate influenza viruses that are 0.1 micrometres in diameter. PFE tests are typically performed on face masks.

Also referred to as Latex Particle Challenge, this test is required for ASTM F2100 and is performed according to the ASTM F2100 and follows the basic principle of ASTM F2299.

Independent Lab: Nelson Labs, USA

Sample Submitted: Helix™ Filter media

Results: The Helix™ Filter captured 99.85% of 0.1um latex particles.

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Bacterial Filtration Efficiency (BFE) according to ASTM F2101

The BFE test evaluates the filtration efficiency of filter media by challenging the filter with a known dosage of the microbe, Staphylococcus aureus. The BFE test is performed on filtration materials and devices that are usually designed to provide protection against biological aerosols, such as face masks, surgical gowns, caps and air filters.

This test is used for FDA 510(k) submissions for surgical masks, is required by ASTM F2100 and EN 14683, and complies with ASTM F2101 and EN14683.

Independent Lab: Nelson Labs, USA

Sample Submitted: Helix™ Filter media

Results: The Helix™ Filter removed 99.99902% of the bacteria.

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Microbial Cleanliness (Bioburden) of Medical Masks

The Bioburden test determines the total number of viable microorganisms (such as microbes) in or on a product.

Independent Lab: Nelson Labs, USA

Sample Submitted: A complete face mask that uses a Helix™ Filter.

Results: Low level of aerobic bacteria and fungi found on the whole mask

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Cytotoxicity

The Cytotoxicity test measures the toxic quality to cells, and is designed to demonstrate the cytotoxic effects of potential leachables from a product/material. This test is usually performed on all medical devices with patient contact, raw materials, and devices undergoing a cleaning validation or residual manufacturing.

The Cytotoxicity/MEM/Agar Overlay meets AAMI/ANSI/ISO 10993-5 requirements as well as USP <87> requirements.

Independent Lab: Nelson Labs, USA

Sample Submitted: A complete face mask that uses a Helix™ Filter.

Results: Test gave a pass. This means the whole mask, including the filter, is considered non-cytotoxic.

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