ASTM F2407/F2407M
Scope
1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in healthcare facilities. Four
levels of barrier properties for surgical gowns are specified in ANSI/AAMI PB70 and are included in this specification for reference purposes.
Note 1: Some properties require minimum performance and others are for documentation
only.
Note 2: ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water
only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to
simulated biological fluids is required for a Level 4 gown.
1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for
evaluating experimental products.
1.3 This specification is not intended to serve as a detailed manufacturing or purchase specification, but can be referenced in purchase specifications as
the basis for selecting test requirements.
1.4 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently
of the other, without combining values in any way.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this
standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on
Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Keywords
barrier performance; critical zone; healthcare; hydrostatic pressure; impact penetration; physical properties; protective clothing; surgical gown; viral penetration resistance;
ICS Code
ICS Number Code 11.140 (Hospital equipment)
DOI: 10.1520/F2407_F2407M-23