Viral Penetration Test

The Viral Penetration Test is designed to evaluate the viral penetration resistance characteristics of personal protective equipment including gowns, drapes, and gloves. The test is required for 510(k) submissions to the FDA, as well as for protective equipment per national fire protection agency regulation. Additionally, this test has been used by textile manufacturers to qualify their product for sale as raw material to medical device manufacturers.

STEMart provides Viral Penetration Test in accordance with AAMI PB70 guidance to help manufacturer determine the level of protection for gowns and drapes. STEMart can perform this test in compliance with applicable ASTM standards for products to be marketed in the U.S. and ISO standards for international markets.

Applicable Standards

• AAMI PB70 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities
• ASTM F1670/1670M Standard Test Method for Resistance of Material Used in Protective Clothing to Penetration by Synthetic Blood
• ASTM F1671 Standard 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
• ASTM F2407 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• ISO 16604 Determination of the Resistance of Protective Clothing Materials to Penetration by Blood-Borne Pathogens
• NFPA 1951 Standard on Protective Ensembles for Technical Rescue Incidents
• NFPA 1971 Standard on Protective Ensembles for Structural Fire Fighting and Proximity Fire Fighting
• NFPA 1999 Standard on Protective Clothing for Emergency Medical Operations

STEMart provides a qualitative determination of the protective clothing material resistance to viral penetration. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.