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Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.
This specification provides minimum requirements for isolation gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. This specification requires barrier testing based on the system of classifying gowns established in ANSI/AAMI PB70 and sets general safety requirements for isolation gowns based on biocompatibility. Performance requirements are established for important physical properties including tensile strength, tear resistance, and seam strength. Methods to be used for optional reporting of performance of linting resistance, evaporative resistance, water vapor transmission rate, abrasion resistance, and flex durability are provided.
While isolation gowns are classified for barrier performance as specified in ANSI/AAMI PB70, this specification establishes other design criteria, physical performance criteria, labeling, and documentation requirements for isolation gowns and their materials.
The below methods from ASTM F3352 are performed at SGS-IPS Testing:
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