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ASTM F3502 - 24
ASTM International (ASTM)
Title

"Standard Specification for Barrier Face Coverings"

Description

This specification is primarily intended to help ensure barrier face coverings meeting the stated requirements provide(1) a means of source control for individual wearers by reducing the number of expelled droplets and aerosols from the wearer’s nose and mouth into the air; and (2) to potentially offer a degree of particulate filtration to reduce the amount of inhaled particulate matter by the wearer.

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.

Personal Protective Equipment
Body Protection

All items of clothing and/or accessories (whether or not detachable) designed and manufactured to provide specific protection. This includes bullet-proof clothing, general protective clothing and full body ensembles that protect from cuts, radiation, temperature extremes, hot splashes from molten metals and other hot liquids, potential impacts from tools, machinery and materials and hazardous chemicals. Examples of body protection include laboratory coats, coveralls, vests, jackets, aprons, surgical gowns and full body suits

  • Particulate protective clothing
Hazards
Gas and Vapor
  • Inhalation
Standard References
Referenced Standard

NFPA 2112 - 2023 edition - Standard on Flame-Resistant Clothing for Protection of Industrial Personnel Against Short-Duration Thermal Exposures from Fire

ISO 16900-5:2016/Amd 1:2018 - Respiratory protective devices -- Methods of test and test equipment -- Part 5: Breathing machine, metabolic simulator, RPD headforms and torso, tools and verification tools -- Amendment 1: RPD head forms front and side view

Incorporated by Reference

29 CFR 1910.134 - Respiratory protection

Associated NIOSH Standard Test Procedure(s) (STP)

TEB-APR-STP-0059 - Determination of Particulate Filter Efficiency Level for N95 Series Filters Against Solid Particulates for Non-Powered, Air-Purifying Respirators Standard Test Procedure (STP)

Conformity Assessment Notes

The conformity assessment requirements for barrier face coverings in this specification have been established to provide confidence that the products labeled as compliant meet all applicable criteria of this specification. Performance requirements in Section 6 must be performed by competent laboratories accredited to ISO/IEC 17025, and the testing performed must be within the scope of the laboratory’s ISO/IEC 17025 accreditation. The manufacturer must also meet all of the Model A requirements in Guide F3050 for other aspects of conformity assessment that address testing/inspection facilities, a quality management system, records retention, ongoing conformity, recalls and safety alerts, and marking. The manufacturer is required to determine compliance with all design, performance, reporting, labeling, user information, and conformity assessment requirements in this specification and provide a declaration of conformation that indicates that their product(s) fulfills all of these requirements

Comments

ASTM Standards

  • D3938 Guide for Determining or Confirming Care Instructions for Apparel and Other Textile Products
  • D5489 Guide for Care Symbols for Care Instructions on Textile Products
  • F1494 Terminology Relating to Protective Clothing
  • F1506 Performance Specification for Flame Resistant and Electric Arc Rated Protective Clothing Worn by Workers Exposed to Flames and Electric Arcs
  • F2100 Specification for Performance of Materials Used in Medical Face Masks
  • F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
  • F2302 Performance Specification for Labeling Protective Clothing Which Provides Resistance to Incidental Exposures to Heat or Open Flame
  • F3050 Guide for Conformity Assessment of Personal Protective Clothing and Equipment
  • F3407 Test Method for Respirator Fit Capability for Negative-Pressure Half-Facepiece Particulate Respirators

AATCC Monograph

  • M14 Guidance and Considerations for General Purpose Textile Face Coverings: Adult

ANSI/ASQC Standard

  • ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes

ISO Standards

  • ISO 2859-1 Sampling Procedures for Inspection by Attributes—Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection
  • ISO/ANSI/AAMI 10993-5 Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity
  • ISO/ANSI/AAMI 10993-10 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization
  • ISO 16900-5 Respiratory Protective Devices—Methods ofTest and Test Equipment—Part 5: Breathing Machine Metabolic Simulator, RPD Headforms and Torso, Tools and Verification Tools
  • ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories

Federal Regulations

  • 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
  • 16 CFR Part 303 Rules and Regulations Under the Textile Fiber Products Identification Act
  • 16 CFR Part 423 Care Labeling of Textile Wearing Apparel and Certain Piece Goods as Amended
  • 29 CFR 1910.134 Respiratory Protection
  • 42 CFR Part 84 Approval of Respiratory Protective Devices

NPPTL Standard Test Procedure

  • TEB-APR-STP-0059 Determination of Particulate Filter Efficiency Level for N95 Series Filters Against Solid Particulates for Non-Powered, Air-Purifying Respirators

NFPA Standard

  • NFPA 2112 Standard on Flame-Resistant Clothing for Protection of Industrial Personnel Against Short-Duration Thermal Exposures from Fire
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