Product Testing

Meeting national and international standards is how Razor Medical Inc. ensures its customers receive the highest quality products in the industry.
Everything from raw materials to the finished product goes through the following five tests, conducted in-house and by third parties:
 
  • Bacterial Filtration Efficiency
  • Particle Filtration Efficiency
  • Synthetic Blood Penetration
  • Differential Pressure
  • Respiratory Resistance

The Bacterial Filtration Efficiency (BFE) test is used to measure a material’s resistance to penetration of bacteria. Our processes uses microbial aerosol liquid spray producing results as percent efficiency and correlating with the ability of the fabric to resist bacterial penetration. This test is performed on filtration materials such as air filters, face masks, surgical gowns and caps that are designed to protect against biological aerosols.

 

This test is used for FDA and Health Canada submissions and complies with ASTM F2100, ASTM F2101 and EN 14683.

Standards:

  • ASTM F2100

  • ASTM F2101

  • EN 14683

The Particle Filtration Efficiency (PFE) test is used to measure a material’s filtering retention against particles. This test is performed on filtration materials such as air filters and face masks that are designed to protect against particle aerosols.

This test is used for FDA and Health Canada submissions and complies with ASTM F2100 and ASTM F2299.

Standards:

  • ASTM F2100

  • ASTM F2299

The Synthetic Blood Penetration or Splash Resistance test is used to measure the resistance of the masks ability to act as a barrier against blood or other liquids. The test uses different levels of synthetic blood volumes directed at high velocity to determine the resistance level.

This test is used for FDA and Health Canada submissions and complies with ASTM F1862, ASTM F2100, EN 14683, ISO 26609, YY 0469 and GB/T 19083.

Standards:

  • ASTM F1862

  • ASTM F2100

  • EN 14683

  • ISO 26609

  • YY 0469

  • GB/T 19083

The Differential Pressure test is used to measure the breathability of masks. Our process is testing through measuring the differential pressure required to draw air through a measured surface area at a constant air flow rate and to test the air exchange pressure of the medical face mask material, which indicates the breathability. 

This test is used for FDA and Health Canada submissions and complies with ASTM F2100, EN 149, EN 14683, MIL-M-36954C, GB 19083, GB 2626, GB/T 32610 and YY/T 0969. 

Standards:

  • ASTM F2100

  • EN 149

  • EN 14683

  • MIL-M-36954C

  • GB 19083

  • GB 2626

  • GB/T 32610

  • YY/T 0969

The respiratory resistance is used for determining the inhalation resistance and exhalation resistance under the regulations of respirators and masks.

This test is in compliance with GB 2626 and GB/T 32610.

Standards:

  • GB 2626

  • GB/T 32610

Bacterial Filtration Efficiency

Particle Filtration Efficiency

Synthetic Blood Penetration

Differential Pressure

Respiratory Resistance

Razor Medical Inc.

560 Courtneypark Dr. W

Mississauga, ON L5W 1L9

647-931-7752

Copyright © 2020 – Razor Medical Inc.