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Category: Masks & General Barrier tests
The Aerobiology/Barrier Section at Nelson Laboratories specializes in testing of materials and medical devices which are designed to provide protection against biological exposures. Filtration efficiency tests are commonly performed to evaluate filter media for aerosol filtration.
Tests available for Masks & General Barrier tests
Viral Penetration Method ASTM F1671
This test procedure is used for evaluating the viral penetration resistance characteristics of protective clothing materials, which are used to protect against bloodborne pathogen hazards. This test procedure was designed to comply with the ASTM F1671 procedure developed by ASTM Subcommittee F23.40 on Biological Hazards. The test device used in this procedure is the ASTM F903 Chemical Penetration Cell.
Bacterial Filtration Efficiency, BFE ASTM F2100, Military spec MIL36954C, ASTM F2101
This test is conducted to determine the filtration efficiency of filtration materials when challenged with a biological aerosol of Staphylococcus aureus. Items such as face masks, surgical gowns, caps, air filters, and other barrier materials can be tested.
Synthetic Blood Penetration ASTM F1670, PB70
This test procedure is used for evaluating the synthetic blood penetration resistance characteristics of protective clothing materials, which are used to protect against bloodborne pathogen hazards. This test procedure was designed to comply with ASTM Method F1670 developed by the ASTM Subcommittee F23.40 on Biological Hazards. This procedure should be used as a preliminary screen for the evaluation of protective clothing materials designed to provide protection against bloodborne pathogen hazards. Protective clothing materials which pass ASTM Method F1670 test should also be tested against the more sensitive ASTM Method F1671 Viral Penetration Test. The test device used for this procedure is the ASTM F903 Chemical Penetration Cell.
Virus filtration efficiency (VFE) ASTM F2101-01, MIL-M-36954C
This procedure is performed to determine the filtration efficiency of various filtration materials, employing a ratio of the challenge to effluent, to determine percent virus filtration efficiency (%VFE)-reported up to >99.9%. The challenge used in this procedure is the bacteriophage φX174, which is commonly used in various types of laboratory testing of barrier and filtration materials. This test procedure allows a reproducible challenge to be delivered to the test samples. The VFE test procedure was adapted from the Military standard MIL-M-36954C and ASTM F2101.
Virus filtration efficiency (VFE) at increased challenge MIL-M-36954C
This Virus filtration efficiency test provides a number of advantages over other filtration efficiency tests. The use of all glass impingers (AGIs) in the collection process allows a high concentration of challenge (the bacteriophage φX174) to be delivered to each test material. Filtration efficiency measurements can be determined up to >99.9999%.
Synthetic blood fluid penetration resistance for face masks ASTM F1862
This test method was developed by ASTM Subcommittee F23.40 on Biological Hazards and and is designed to comply with ASTM F1862.
NIOSH respirator evaluations 21 CFR Part 84
For NIOSH evaluation, 20 filters are evaluated for particle penetration. Filters are loaded until 200 mg contacts the filter or until maximum penetration occurs.
AAMI PB70 AAMI PB70, ASTM F1670, ASTM F1671, AATCC 42, AATCC 127
The requirements for AAMI PB 70 are to follow the ASTM, AATCC and other standards issued to classify surgical drapes and gowns. The number of test sites and product classification determine the type of test to be performed. Test options include Hydrostatic Pressure, Spray Impact, Synthetic Blood Penetration and Viral Penetration as listed below. Contact the Sales Department at sales@nelsonlabs.com for a full PB70 quote on your product and an appropriate sampling plan as outlined in the guidance.
Sodium chloride (NaCl) aerosol challenge 42 CFR Part 84, 29 CFR Part 1910.134
NaCl aerosol testing is a widely accepted method for evaluating particle penetration and air flow resistance properties of a variety of filtration materials (e.g. Breathing system filters, NIOSH respirators, and face masks). The procedure employs an aerosol of NaCl using a TSI® CERTITEST® Model 8130 Automated Filter Tester. Test articles are challenge with particles of the most penetrating particle size range, (0.3) µm. Filtration efficiency measurements can be determined up to 99.999%. Samples can be tested at airflow rates up to 90 L/min.
Flammability test- 16 CFR Part 1610 16 CFR Part 1610
This test method is designed to comply with 16 CFR Part 1610. The ASTM F 2100 (Standard Specification for Performance of Materials Used in Medical Face Masks) requires that all face masks meet the requirements for Class 1 flammability. This method is appropriate for a variety of medical textiles, including surgical gowns and drapes.
Hydrostatic Pressure Test AATCC 127, INDA IST 80.6, ISO 811
This is designed to determine a materials resistance to water penetration. This test procedure employs the use of a hydrostatic head tester. The procedure complies with AATCC 127, ISO 811, and INDA IST 80.6
Filtration efficiency; Dioctyl phthalate (DOP) 21 CFR Part 84.181
The DOP test procedure can evaluate particle penetration and air flow resistance properties of a variety of filtration materials (e.g. HEPA filters, NIOSH respirators, and filter media). The procedure employs a cold aerosol of dioctyl phthalate (DOP) using a TSI® CERTITEST® Model 8130 Automated Filter Tester. Test articles are challenged with particles of the most penetrating particle size range (0.3 µm). Filtration efficiency measurements can be determined up to 99.999%. Samples can be tested at flowrates up to 90 L/min.
Glove Puncture Resistance ASTM F1342
This test method determines the puncture resistance of a material specimen by measuring the force required to cause a sharp-edged puncture probe to penetrate through the specimen. This test method is covered as defined in ASTM F1342.
Differential pressure only, ASTM Military spec, MIL36954C, ASTM F2100
The differential pressure test determines the air exchange differential of porous materials. The differential pressure test was designed after Military Specification 36954C and is commonly requested for samples which are submitted for bacterial filtration efficiency (BFE) testing.
Spray impact test AATCC 42, INDA IST Method 80.3, ISO, AAMI PB70
This procedure is designed to measure the resistance of materials to water penetration under contact with sprayed water. The procedure complies with AATCC Test Method 42 and the INDA IST Method 80.3. This procedure is required by the AAMI PB70 standard.
Helmke drum particle counts IEST CC-RP-003.3 B2.5
The helmke drum test is conducted by tumbling test samples in a stainless steel drum to determine the particle counts on wipers, instrument wraps, face masks, and similar woven and non-woven fabrics.
Gelbo flex test ISO 9073-10
This test assessing the linting of nonwovens in a dry state. The test sample is subjected to a combined twisting and compression action in a test chamber using a Gelbo Flex mechanism. During the flexing, air is withdrawn from the chamber and the particulates generated are enumerated and sized using a laser particle counter.
Latex particle challenge (Particle filtration efficiency- PFE)
The Latex Particle Challenge test is conducted to evaluate the non-viable particle retention or filtration efficiency of filter media and other filtration devices at sub-micron levels.
Tensile test, elastomeric materials ASTM D412
Fabrics are tested by the strip method (ASTM D5035) or the grab test (ASTM D5034). Plastics are tested according to ASTM D882, ASTM D638, and ASTM D412.
Endoscope viral barrier test
This outline details procedures for evaluation of the barrier properties of covers or sheaths. A simulated probe is placed in the covers. The covers are suspended in a container filled with sterile solution and then filled with a suspension of the challenge virus Phi-X174 at a concentration ≥108 plaque forming units (PFU) per mL. The covers will be agitated throughout the challenge procedure on an orbital shaker operated at 100-125 revolutions per minute (rpm). Shaking will be performed at 37 ± 2°C to simulate clinical use conditions. The external liquid will be assayed for the challenge virus Phi-X174 using plaque assay techniques at each of the following time intervals: 0 and 60 minutes. Positive, negative, and percent recovery controls will be included in the test.