The EN 13795-1 standard provides information on the characteristics of disposable and reusable surgical gowns and drapes used as medical devices to prevent the transmission of infective agents between clinicians and patients during surgery and other medical procedures. It also provides test methods to evaluate the specified properties of these surgical drapes and gowns and performance requirements for these products.
This European Standard specifies information to be provided to users and third-party verifiers regarding manufacturing and processing requirements, in addition to the usual labeling of medical devices. This European Standard provides information on the characteristics of disposable and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment aimed at preventing the transmission of infective agents between clinical staff and patients during surgery and other invasive procedures.
This European Standard specifies test methods for evaluating the defined properties of surgical drapes and gowns and sets performance requirements for these products. EN 13795-1 does not cover requirements for products to resist penetration by laser radiation.
Briefly, surgical drapes are generally used in operating theaters to protect the patient, clinical staff and equipment. These covers can be made of fabric or paper and can be reused or disposable.
EUROLAB assists manufacturers with EN 13795-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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