The standard for surgical fabrics is determined by EN 13795 and AATC, ASTM and AAMI. According to this standard, covers are divided according to their classes and the minimum requirements of each class are determined. Medical and protective fabrics should have the following features.
- Antimicrobial textiles should not harm human and environmental health.
- It should have selective activity against unwanted microorganisms.
- They are resistant to washing, dry cleaning and heat treatment (they should maintain their antimicrobial activity for a long time, especially as a result of repeated washes).
- Applied antimicrobial agents and application methods should not adversely affect the quality properties and appearance of textile products such as attitude and strength.
- It should be suitable for the production and finishing processes that textile materials will see later.
- It must be resistant to sterilization processes.
- Must be resistant to body fluids
- Air permeability
- FiltBacterial filtration efficiency%
- Splash resistance
The Bacterial Filtration Efficiency (BFE) test is performed on filtering materials and devices designed to protect against biological aerosols such as face masks, surgical gowns, caps, and air filters. Download the Medical Face Mask Tests and Requirements dump HERE.
This test is used for FDA 510 (k) references for surgical masks, is required for ASTM F2100 and EN 14683 and complies with ASTM F2101 and EN14683. Nelson Labs staff helped develop this test method, so we have more experience with this test than any other lab.
Applicable Standards
- ASTM F2100
- EN 14683
- ASTM F2101
Bacterial Filtration Efficiency (BFE)
The Bacterial Filtration Efficiency test determines the filtration efficiency by comparing the bacterial control numbers with the test substance waste numbers. The test is carried out using Staphylococcus aureus as the challenge organism. After the pre-conditioning of the filtrate medium, the liquid suspension of S. aureus is aerosolized and sent to the filtrate medium at a constant flow rate of 28.3 liters per minute (LPM) or 1 cubic meter per minute (CFM).
Aerosol droplets are drawn from the six-stage Andersen sampler for collection. The number of bacterial aerosol droplets that come into contact with the filter medium is determined by performing test controls in the test system without the filter medium. Difficulty controls are maintained at 3.0-0.3 colony forming units (CFU) with an average particle size (MPS) of 1700 ± 3000 µm. This allows filtration efficiency to be reported up to> 99,9%.
The BFE test offers a number of advantages over other filtration efficiency tests. It has been used for years with little or no modifications and provides a standard reference for comparison of filtration materials. The average particle size can be tightly controlled and is sized using a six-stage viable particle Andersen sampler that allows for step-by-step analysis. The BFE procedure is repeatable and creates a more serious challenge for most filtration devices than expected in normal use. Many materials can be evaluated in a relatively short time.
The BFE test is usually done in conjunction with the Differential Pressure (Delta P) test.
We recommend the Increasing Difficulty method for built-in filters. This procedure uses a higher concentration concentration to be delivered to each test material. Filtration efficiency measurements can be determined up to> 99.9999%.
Increased Difficulty Bacterial Filtration Efficiency (BFE)
Increased Bacterial Filtration Efficiency test determines filtration efficiency by comparing bacterial control numbers with test substance waste numbers. The test is carried out using Staphylococcus aureus as the challenge organism. A liquid suspension of S. aureus is aerosolized and introduced into the filtration medium at a constant flow rate of 30 liters per minute (LPM).
Aerosol droplets are collected in parallel in all glass impacts (AGI). Difficulty is given at one minute intervals and sampling of AGIs is performed for two minutes to clean the aerosol chamber. The titer of the assay fluid is determined using standard plate count and / or membrane filtration techniques. The number of bacterial aerosol droplets that come into contact with the filter medium is determined by testing without filter media in the test system. The square control is maintained at 1 x 10 6 colony-forming units (CFU) with an average particle size (MAS) of 3.0 ± 0.3 μm. This allows filtration efficiencies to be reported up to> 99.9999%.
The increased BFE test offers a number of advantages over other filtration efficiency tests. It has been used for years with little or no modifications and provides a standard reference for comparison of filtration materials. The increased BFE procedure is very repeatable, easy to do, and creates a more serious challenge than expected in most filtering devices.
Viral Filtration Efficiency (VFE)
The Viral Filtration Efficiency (VFE) test follows the same procedure as BFE, except that the coercive organism used is bacteriophase phiX174.
Difficulty controls are maintained in 3.0-0.3 plaque-forming units (PFU) with an average particle size (MPS) of 1100 ± 3300 µm. This allows filtration efficiency to be reported up to> 99,9%.
Increased Task Virus Filtration Efficiency (VFE)
The increased VFE test follows the same procedure as BFE, except that the used organism of difficulty is bacteriophase phiX174.
The square control is maintained at ≥1 x 10 6 plate-forming units (PFU) with an average particle size (MAS) of 3.0 ± 0.3 μm. This allows filtration efficiencies to be reported up to> 99,9999%
ASTM E2149
The ASTM E2149 method, entitled "Determining the Antimicrobial Activity of Immobilized Antimicrobials Under Dynamic Contact Conditions", is a sensitive test that is often used to measure the antimicrobial activity of non-leaching, irregularly shaped or hydrophobic surfaces. Simply put, it measures the antimicrobial activity of antimicrobial surfaces when they are shaken in a microbially contaminated solution.
EUROLAB Laboratory finds the method to be brought as a model system and applies it regularly. Why is that? Because it is one of the only ways to test an irregularly shaped antimicrobial object such as thread, powder or 3D molded plastic in a standard way. If an antimicrobial object can be tested as a plain coupon, we recommend using JIS Z 2149 / ISO 2801 instead of ASTM E22196.
ASTM E2149 is designed for leak-proof (water-insoluble and water-insoluble) antimicrobial products or surfaces, so as part of the test, products are analyzed for leaching of antimicrobial agents using standard experiments. If leakage of an antimicrobial agent can be detected, neutralization of the active ingredient must be verified to verify the results.
ASTM F1862/F1862M
Standard Test Method for Resistance of Medical Facial Masks to Penetration with Synthetic Blood (Horizontal Projection of Constant Volume of Known Speed)
This test method provides a procedure for evaluating medical face mask resistance to synthetic blood penetration, which is useful in making claims and ranking their performance for penetration resistance performance of medical face masks. However, this test method does not define acceptable levels of penetration resistance, since this determination must be made by each responsible user organization according to its specific application and conditions. Therefore, when using this test method to make claims about the performance of medical face masks, certain conditions under which the test is performed should be explained.
Test method
A precise procedure that produces a test result: Examples of test methods include, but are not limited to, defining, measuring, and evaluating one or more qualities, characteristics, or features. A statement of certainty and bias will be reported at the end of a test method.
All equipment and / or accessories (whether or not removable) specially designed and manufactured to protect the eyes and / or the entire face (except for the top of the head). Eye or face hazards due to flying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical gases or vapors, potentially infected material or potentially harmful light radiation.
AAMI CLASSIFICATION
There are four tests to be performed There are four tests to be performed, to evaluate the performance of the surgical gown to evaluate its performance.
- Spray Impact Penetration Test
- Hydrostatic Head Test
- Synthetic blood resistance
- Viral penetration resistance
AATCC 42 Spray Impact Penetration Test
AATCC 42 Water Resistance applies to any textile fabric with or without a water-resistant or water-repellent coating. The test measures the resistance of fabrics to water penetration and can thus be used to estimate the possible resistance of fabrics to rain penetration. It is especially suitable for measuring the penetration resistance of garment fabrics. The results obtained with this test method depend on the water repellency of the fibers and yarns, and the structure and finishing of the fabric.
Principle
A volume of water is allowed to be sprayed onto a stretched surface of a test sample supported with a weighed blotter. The blotter is then re-weighed to determine the water penetration and the sample is classified accordingly.
ASTM F1670/1670M
Resistance of Materials Used in Protective Clothing to Synthetic Blood Penetration
ASTM F 1670 Blood Penetration is used to evaluate the resistance of materials used in protective suits to the penetration of synthetic blood under continuous fluid contact conditions. Protective clothing pass / fail determinations are based on visual detection of synthetic blood penetration. This test method is not always effective in testing protective clothing materials with thick inner linings that easily absorb synthetic blood. This test method is a tool for selecting protective clothing materials for subsequent tests with a more complex barrier test as described in Test Method F1671.
This test method does not apply to all forms or conditions of bloodborne pathogen exposure. Users of the test method should review the modes for work / clothing exposure and evaluate the suitability of this test method for specific applications. This test method only deals with the performance of materials used in protective clothing or certain material structures (eg seams). This test method does not address the design, overall structure and components or interfaces of garments, or other factors that may affect the overall protection offered by the protective suit.
Values specified in SI units or inch-pound units should be considered standard separately. The values specified in each system may not be exactly equivalent; therefore, each system will be used independently of the other. Combining values from the two systems can result in non-compliance with the standard.
Summary of Test Method
A sample is subjected to body fluid simulation (synthetic blood) for a specified time and pressure. Visual observation is done to determine when the penetration will occur. Any evidence of synthetic blood penetration creates failure. Results are reported as successful / unsuccessful.
Other Protective Medical Fabric Tests
- Water vapor transmission rate
- Tensile Strength
- Air Permeability
- Hardness
- flammability
- Bursting strength
- Thermal resistance
TS EN 13795-1
Surgical drapes, gowns and clean air clothes used as medical devices for patients, clinical staff and equipment - Part 1: General features for manufacturers, processors and products
EUROLAB Laboratory provides test and analysis services to companies producing surgical medical protective fabrics.