Certifications


ABOUT ASTM

ASTM International is one of the world's largest international standards developing organizations with over 120 years of experience. Today, ASTM comprises of 30,000 volunteer members from more than 140 countries representing producers, users, consumers, government, and academia. Through science, engineering and good judgment, ASTM improves performance in manufacturing and materials, products and processes, systems and services.

Many governing institutions and business corporations choose their standards as a trusted benchmark worldwide. This spans from areas such as metals, paints, plastics, textiles, petroleum, construction, energy, the environment, consumer products, medical services, devices and electronics, advanced materials and much more.

About ASTM F2100-19

ASTM F2100-19 is the latest standard for the testing and requirements for materials used in constructing the medical face masks that are used in providing healthcare services such as surgery and patient care.

Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Terms & Terminologies (as provided by ASTM F2100-19)

FLUID RESISTANCE represents the mask’s resistance to penetration by synthetic blood under pressure (mmHg). It measures the ability of a mask’s material construction to minimize fluids from traveling through the material and potentially coming into contact with the wearer. The higher the fluid resistance (filtration), the better the protection.

BFE (Bacterial Filtration Efficiency) represents the percentage of aerosol particulates filtered at a size of 3 microns. It is the measure of the efficiency of the mask in filtering bacteria passing through it.

PFE (sub-micron Particulate Filtration Efficiency) represents the percentage of submicron particulates filtered at 0.1 microns. PFE is the measure of the efficiency of the mask in filtering particles passing through it. The size of the particles filtered is critical.

DELTA P (Differential Pressure) represents the pressure drop across the mask or resistance to air flow in mmH2O/cm2. This determines breathing resistance – the higher the Delta P, the less the breathability, but the better the filtration.

FLAME SPREAD is a ranking derived by laboratory standard test methodology of a material’s propensity to burn rapidly and spread flames.


Tests and Requirements Specification


ABOUT HSA

The Health Sciences Authority (HSA) is a statutory board and multi-disciplinary agency under the Ministry of Health in Singapore. It applies medical, pharmaceutical and scientific expertise to protect and advance public health and safety.

The organisation is the national regulator for health related products and holds world-class capabilities in forensic medicine, forensic science and analytical chemistry testing. These support other regulatory and compliance agencies in the administration of justice and safeguarding public health.

HSA License: ES0501407


COSMES is certified with Cleanroom ISO Class 7.

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