1. 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.