EN 13795-3 Surgical Drapes, Gowns and Clean Air Garments Used as Medical Devices for Patients, Clinical Staff and Equipment - Performance Requirements and Performance Levels

Material Testing

EN 13795-3 Surgical Drapes, Gowns and Clean Air Garments Used as Medical Devices for Patients, Clinical Staff and Equipment - Performance Requirements and Performance Levels

This standard specifies information to be provided to users and third-party verifiers in addition to the usual labeling of medical devices regarding manufacturing and processing requirements.

EN 13795-3 Surgical Drapes, Gowns and Clean Air Garments Used as Medical Devices for Patients, Clinical Staff and Equipment - Performance Requirements and Performance Levels

It gives general information about the characteristics of disposable and reusable surgical gowns, surgical drapes and fresh air suits used as medical devices for patients, clinical staff and equipment. It aims to prevent the transmission of infectious agents between patients and clinical staff during surgery and other invasive procedures.

EN 13795 closes the missing technical link regarding compliance with the regulations of the european council directive 93/42/EEC, often referred to as the medical device directive. The medical device directive was published in 1993 and became mandatory in all European and EFTA countries in 1998, replacing previous national legislation. MDD applies to all medical devices and broadly describes the basic requirements.

The core requirements regulate the design and construction of medical devices and clarify key parameters to ensure that medical devices do not endanger the safety and health of patients and healthcare professionals.

These parameters include chemical, microbiological and physical properties as well as conditions for safe use, storage, transportation and labeling. Each device is classified as class I, class II or class III according to its intended use and associated risks. Class I covers non-invasive devices such as surgical gowns, drapes and fresh air suits. Classes II and III relate to devices that pose a potential higher risk to patients and healthcare professionals.

EUROLAB assists manufacturers with EN 13795-3 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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