In today’s world, medical gowns have become an essential part of our lives. Medical gowns are designed to protect healthcare workers from various types of infections and diseases. These gowns are also worn by patients in different medical facilities, especially when undergoing surgery or any other medical operation. With the increase in the number of patients and the growing need for medical assistance, it has become essential to have proper gowns that meet the required medical gown standards.
The importance of having medical gowns that meet the required standards cannot be overstated. These standards ensure that the disposable medical gowns are designed to provide maximum protection and are made from quality materials that can withstand various environmental and physical conditions. Several standards have been established to regulate the production, sale, and use of medical gowns. In this article, we will discuss some of these standards.
American National Standards Institute (ANSI)
ANSI works closely with the healthcare industry to develop standards that ensure the safety and well-being of both patients and healthcare workers. The ANSI standard for disposable isolation gowns provides guidelines for the design, construction, and performance of disposable gowns. The standard specifies the minimum requirements for the strength, moisture resistance, and barrier protection of the gowns.
American Society for Testing and Materials (ASTM)
ASTM is a global organization that develops and publishes technical standards for various industries, including healthcare. ASTM has established several medical gown standards, including the ASTM F2407-06, which specifies the minimum requirements for surgical gowns and drapes. The standard covers the design, construction, and performance of gowns and drapes used in surgical procedures.
European Committee for Standardization (CEN)
CEN is a European standards organization that provides guidelines for the production, sale, and use of various products, including medical gowns. The organization has established several standards for medical gowns, including the EN 13795-1:2019, which specifies the general requirements for surgical gowns and drapes. The standard covers the requirements for materials, design, performance, and labeling of surgical gowns and drapes.
International Organization for Standardization (ISO)
ISO is a global standards organization that provides guidelines for the production, sale, and use of various products, including medical gowns. The ISO standard for medical gowns, ISO 16603:2004, specifies the resistance of materials used in protective clothing against penetration by blood-borne pathogens. The standard also covers the requirements for the design and performance of protective clothing used in healthcare facilities.
Food and Drug Administration (FDA)
The FDA is a federal agency in the United States that regulates the production, sale, and use of medical products, including medical gowns. The FDA has established several regulations for medical gowns, including the 510(k) clearance, which is required for the sale of new medical gowns. The FDA reviews the design, construction, and performance of medical gowns to ensure that they meet the required standards before allowing them into the market.
Medical gowns are an essential requirement in today’s healthcare facilities. They play a vital role in protecting both patients and healthcare workers from various infections and diseases. There are several established standards for medical gowns, including the ANSI, ASTM, CEN, ISO, and FDA. These standards ensure that medical gowns are designed to provide maximum protection and are made from quality materials that can withstand various environmental and physical conditions. It is crucial for healthcare facilities to use medical gowns that meet the required standards to ensure the safety and well-being of both patients and healthcare workers.
