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ASTM International (ASTM)
Title

"Standard Specification for Performance of Materials Used in Medical Face Masks"

Description

This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing health care services such as surgery and patient care.

Standard Type(s)
Specification

An explicit set of requirements to be satisfied by a material, product, system, or service: Examples of specifications include, but are not limited to, requirements for; physical, mechanical, or chemical properties, and safety, quality, or performance criteria. A specification identifies the test methods for determining whether each of the requirements is satisfied.

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
    • 29-1011 Physicians, Chiropractic
    • 29-1067 Surgeons
    • 29-1140 Registered Nurses
Standard References
Referenced Standard

ASTM F1494 - 14 - Standard Terminology Relating to Protective Clothing

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 F2299 / F2299M - 03(2017) - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

ASTM F1862 / F1862M - 17 - Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

Conformity Assessment Notes

This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. This specification does not address all aspects of medical face mask design and performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory protection, which may be necessary for some health care services.  This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.  Please see the full standard for complete details. 

Comments

Additional References:

ASTM Standards

  • F1494 Terminology Relating to Protective Clothing
  • F1862 Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
  • F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
  • F2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

ANSI/ASQC Standard

  • ANSI/ASQCZ1.4 Sampling Procedures and Tables for Inspection by Attributes

ISO Standard

  • ISO2859-1 Sampling Plans for Inspection by Attributes

Military Standard

  • MIL-M-36954C Military Specification, Mask, Surgical, Disposable

Federal Standards

  • 42CFRPart84 Approval of Respiratory Protective Devices
Testing Laboratories
Trace Laboratories - Denver, CO, 80126
Contact

Phone Number: (410) 584 9099
Email: sbrammer@tracelabs.com

Accreditations

ISO 17025

Scope of Accreditation

ASTM D5151 - 06(2015) , ASTM D6124 - 06(2017) , ASTM F1342 / F1342M - 05(2013)e1 , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 13 , ASTM F2100 - 11(2018) , ASTM F2101 - 14 , ASTM F1819 - 07(2013)

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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