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ASTM International (ASTM)
Title

"Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)"

Description

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.

Standard Type(s)
Test Method

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.

Personal Protective Equipment
Eye and Face Protection

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
Hazards
Biological
  • Biological
SOC Codes
29-0000 Healthcare Practitioners and Technical Occupations
  • 29-1000 Health Diagnosing and Treating Practitioners
    • 29-1060 Physicians and Surgeons
    • 29-1141 Nurses, Registered
Standard References
Referenced Standard

ASTM F2101 - 14 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

ASTM F1670 / F1670M - 17a - Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

ASTM F1671 / F1671M - 13 - 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 F1494 - 14 - Standard Terminology Relating to Protective Clothing

29 CFR 1910.1030 - Bloodborne pathogens

Conformity Assessment Notes

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.

Comments

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
Testing Laboratories
Nelson Laboratories, Inc. - Salt Lake City, UT, 84123
Notes

FDA Registered and ANSI-ASQ National Accreditation Board/ACLASS

Contact

Phone Number: (801) 290-7500
Email: sdrosner@nelsonlabs.com

Accreditations

ISO 17025

Scope of Accreditation

ASTM D5151 - 06(2015) , ASTM D6124 - 06(2017) , ANSI/AAMI PB70 , ASTM F1342 / F1342M - 05(2013)e1 , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 13 , ASTM F1862 / F1862M - 17 , ASTM F2100 - 11(2018) , ASTM F2101 - 14 , ASTM F1819 - 07(2013) , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3

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