What testing is required to show a gown’s resistance to permeability by HDs?

The correct choice of ASTM F739-12 testing is essential for demonstrating a gown's resistance to permeability by hazardous drugs (HDs). This standard outlines a method for evaluating the protective performance of materials used in protective clothing, specifically measuring their resistance to permeation by chemical substances. In the context of healthcare and handling hazardous drugs, it is critical to ensure that gowns can effectively prevent the passage of these substances, which could pose a risk to healthcare workers and patients alike.

ASTM F739-12 specifically tests for the time it takes for a chemical to permeate through the fabric, providing a clear assessment of the garment's protective qualities in a real-world application. This focus on permeation resistance directly supports the safety standards set forth in USP Chapter <800>, which governs the handling of hazardous drugs to minimize exposure risks.

Other options, while relevant to various aspects of safety and quality in medical and pharmaceutical practices, do not specifically address the permeability testing of gowns as required by USP <800>. NIOSH Type B Certification pertains to respirators rather than gowns. ISO 13485 is a standard for quality management systems specific to medical devices but does not focus on individual tests for garment permeability. The FDA Approval Process is broader and doesn't specifically pertain to the