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 and are included in this specification for reference purposes.  Please see the full standard for complete details.

Includes design and performance requirements.

Additional References:

ASTM Standards

• D751 Test Methods for Coated Fabrics
• D1683 Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
• D1776 Practice for Conditioning and Testing Textiles

• D4966 Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method)

• D5034 Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)

• D5587 Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• D6701 Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers (Withdrawn 2008)

• E96/E96M Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials

• F1154 Practices for Evaluating the Comfort, Fit, Function, and Durability of Protective Ensembles, Ensemble Elements, and Other Components
  

• F1494 Terminology Relating to Protective Clothing

• F1868 Test Method for Thermal Resistance, Evaporative Resistance, and Total Heat Loss Measurements of Clothing Materials Using a Sweating Hot Plate
  

• F1671 Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

• F3050 Guide for Conformity Assessment of Personal Protective Clothing and Equipment
  

• F3352/F3352M Specification for Isolation Gowns Intended for Use in Healthcare Facilities
  

AAMI Documents

• AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities

• ANSI/AAMI ST65 Processing of Multiple-Use Surgical Textiles for Use in Healthcare Facilities
  

• AAMI TIR11 Selection of Surgical Gowns and Drapes in Healthcare Facilities
• ANSI/AAMI BE78 Biological Evaluation of Medical Devices, Part 10: Test for Irritation and Sensitization
  

AATCC Standards

• AATCC 42 Water Penetration Resistance: Impact Penetration Test
• AATCC 127 Water Resistance: Hydrostatic Pressure Test

ANSI/ASQC Standard

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

• ANSI/ASQ Z1.9 Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
  

ISO Standards

• ISO 2859-1 Sampling plans for inspection by attributes
• ISO 3951 Sampling procedures and charts for inspection by variables for percent non-conforming
• ISO 9073 Part 10 Textiles—Test methods for nonwovens—Part 10: Lint and other particles generation in the dry state

• ISO 10993-5 Biological Evaluation of Medical Devices—Part 5: Tests for in Vitro Cytotoxicity

• ISO 10993-7 Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals

• ISO 10993-10 Biological Evaluation of Medical Devices—Part 10: Tests for Skin Sensitization

• ISO 10993-23 Biological Evaluation of Medical Devices—Part 23: Tests for Irritation

• ISO 11134 Sterilization of Healthcare Products—Requirements for Validation and Routine Control—Industrial Moist Heat Sterilization

• ISO 11135 Medical Devices—Validation and Routine Control of Ethylene Oxide Sterilization

• ISO 11137 Sterilization of Healthcare Products—Requirements for Validation and Routine Control—Radiation Sterilization
  

• ANSI/AAMI/ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes

• ISO 13683 Sterilization of Healthcare Products—Requirements for Validation and Routine Control of Moist Heat Sterilization in Healthcare Facilities
  

• ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories

• ISO/IEC 17026 Conformity Assessment—Example of a Certification Scheme for Tangible Products

Federal Standards

• 16 CFR 1610 Standard for the Flammability of Clothing Textiles, Federal Register, Vol. 40, No. 59891, Dec. 30, 1975

• 16 CFR 1611 Standard for the Flammability of Vinyl Plastic Film, Federal Register, Vol 40, No. 59891, Dec. 30, 1975

• 21 CFR 801.437 User Labeling for Devices That Contain Natural Rubber921 CFR 820 Subpart K Labeling and Packaging Control,Federal Register, Vol 8, April 1, 2019

• 29 CFR Part 1910.1030 Occupational Exposure to Bloodborne Pathogens: Final Rule, Federal Register, Vol. 66, No. 12 / Thursday, January 18, 2001.

• Food and Drug Administration UDI FDA Final Rule from Federal Register
  

INDA Standard

• WSP 70.4 Water Vapor Transmission Rate—Mocon Method