PPE-Info - Standard Details

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 - 23 - Standard Terminology Relating to Protective Clothing

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)

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

ASTM F2299 / F2299M - 24 - Standard Test Method for Determining the Initial Efficiency of Materials to Penetration by Particulates Using Latex Spheres

29 CFR 1910.1030 - Bloodborne pathogens

42 CFR 84.1 - Approval of Respiratory Protective Devices: Subpart A: General Information

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
F3050 Guide for Conformity Assessment of Personal Protective Clothing and Equipment
F3502 Specification for Barrier Face Coverings

ANSI/ASQC Standard

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

ISO Standard

ISO2859-1 Sampling Plans for Inspection by Attributes
ISO 10993-1 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process
ISO 10993-5 Biological Evaluation of Medical Devices—Part 5: Tests for in vitro Cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-23 Biological Evaluation of Medical Devices—Part 23: Tests for Irritation
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
ISO/IEC 17026 Conformity Assessment—Example of a Certification Scheme for Tangible Products

European Standard

EN 14683 Medical Face Masks—Requirements and Test Methods

Federal Standards

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
21 CFR Section 878.4040 Surgical Apparel
29 CFR Part 1910.1030 Occupational Exposure to Blood borne Pathogens: Final Rule
42 CFR Part 84 Approval of Respiratory Protective Devices

Testing Laboratories

Intertek - Cortland, NY, 13045

Contact

Phone Number: (607) 753-6711
Email: jason.allen@intertek.com

Accreditations

ISO 17025

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