"Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)"
This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is useful in establishing claims for penetration resistance performance of medical face masks and ranking their performance. However, this test method does not define acceptable levels of penetration resistance because this determination must be made by each responsible user organization based on its own specific application and conditions. Therefore, when using this test method to make claims for the performance of medical face masks, the specific conditions under which testing is conducted must be described.
A definitive procedure that produces a test result: Examples of test methods include, but are not limited to: identification, measurement, and evaluation of one or more qualities, characteristics, or properties. A precision and bias statement shall be reported at the end of a test method.
All equipment and/or accessories (whether or not detachable) designed and manufactured specifically to protect the eyes and/or the entire face (not including the top of the head). Exposure to the eye or face hazards from flying particles, molten metal, liquid chemicals, acids, or caustic liquids, chemical gasses, or vapors, potentially infected material or potentially harmful light radiation.
- Face masks
- Biological
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29-1000 Health Diagnosing and Treating Practitioners
- 29-1060 Physicians and Surgeons
- 29-1141 Nurses, Registered
ASTM F1494 - 23 - Standard Terminology Relating to Protective Clothing
ASTM F1670 / F1670M - 17a - Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
ASTM F1671 / F1671M - 22 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
ASTM F2101 - 23 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
29 CFR 1910.1030 - Bloodborne pathogens
This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration. Please see the full standard for complete details.
Additional References:
ASTM Standards
- D891 Test Methods for Specific Gravity, Apparent, of Liquid Industrial Chemicals
- D1331 Test Methods for Surface and Interfacial Tension of Solutions of Surface-Active Agents
- E105 Practice for Probability Sampling of Materials
- E171 Practice for Conditioning and Testing Flexible Barrier Packaging
- F1494 Terminology Relating to Protective Clothing
- F1670 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
- F1671 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
- F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
ANSI/ASQC Standard
- ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes
ISO Standard
- ISO 2859-1 Sampling Plans for Inspection by Attributes
Military Standards
- MIL-M-36954C Military Specification, Mask, Surgical, Disposable
OSHA Standard
- 29 CFR Part 1910.1030 Occupational Exposure to Bloodborne Pathogens: Final Rule, Federal Register, Vol 56, No 235, Dec. 6, 1991, pp. 64175–64182
Intertek - Cortland, NY, 13045 |
Contact |
Phone Number: (607) 753-6711 |
Accreditations |
Scope of Accreditation |
ANSI/ISEA Z87.1-2020 , ASTM F2412 - 18a , ASTM D120 - 22 , ASTM D3577 - 19(2023) , ASTM D3578 - 19(2023) , ASTM D5250 - 19(2023) , ASTM D5712 - 15(2020) , ASTM D6319 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ASTM F1446 - 20 , ANSI/AAMI PB70:2022 , ASTM F1342 / F1342M - 05(2022) , ASTM F1359 / F1359M - 22 , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F1790 / F1790M - 15 (Reapproved 2021) , ASTM F2588 - 12(2020) , ASTM F739 - 20 , ASTM F903 - 18 , ASTM F1862 / F1862M - 17 , ASTM F2100 - 23 , ASTM F2101 - 23 , ASTM F2299 / F2299M - 24 , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3 |
Nelson Laboratories, Inc. - Salt Lake City, UT, 84123 |
Notes |
FDA Registered and ANSI-ASQ National Accreditation Board/ACLASS |
Contact |
Phone Number: (801) 290-7500 |
Accreditations |
Scope of Accreditation |
ASTM D120 - 22 , ASTM D3577 - 19(2023) , ASTM D3578 - 19(2023) , ASTM D5151 - 19(2023) , ASTM D5250 - 19(2023) , ASTM D5712 - 15(2020) , ASTM D6124 - 06(2022) , ASTM D6319 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ANSI/AAMI PB70:2022 , ASTM F1342 / F1342M - 05(2022) , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F903 - 18 , ASTM F1862 / F1862M - 17 , ASTM F2100 - 23 , ASTM F2101 - 23 , ASTM F1819 - 19 , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3 |
- Page last reviewed: February 21, 2024
- Page last updated: February 21, 2024
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