This specification establishes the requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. It does not however cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. Barrier testing shall be conducted to determine the impact penetration, hydrostatic resistance, and viral penetration resistance performance of the critical zone(s) of the surgical gown. The physical properties of the critical zone(s) of the surgical gown shall also be tested and shall conform to the following requirements: tensile strength, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission rate. General safety requirements shall be set based on biocompatibility, sterility assurance, flame spread, and natural rubber latex specifications.
1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. Four levels of barrier properties for surgical gowns are specified in AAMI PB70:2003 and are included in this specification for reference purposes.Note 1
Some properties require minimum performance and others are for documentation only.Note 2
AAMI PB70:2003 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.
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 and health practices and determine the applicability of regulatory limitations prior to use.