EN 60601-2-12 Medical Electrical Equipment, Part 2-12: Special Requirements for the Safety of Lung Ventilators, Critical Care Ventilators

Medical Device Tests

EN 60601-2-12 Medical Electrical Equipment, Part 2-12: Special Requirements for the Safety of Lung Ventilators, Critical Care Ventilators

EUROLAB laboratory provides testing and compliance services within the scope of EN 60601-2-12 standard. This particular standard specifies safety requirements for ventilators. It is designed for use in intensive care settings.

EN 60601-2-12 Medical Electrical Equipment, Part 2-12: Special Requirements for the Safety of Lung Ventilators, Critical Care Ventilators

Continuous positive airway pressure (CPAP) devices, sleep apnea therapy devices, supportive-care ventilators, emergency and transport ventilators, jet and high-frequency ventilators and oscillators are outside the scope of this special standard and are not devices that can be used in hospitals, but are only intended to increase ventilation of spontaneously breathing patients. . Standards for other types of aerators are being considered, for example high-frequency jet and oscillating fans.

Ventilator breathing system attachments and subassemblies for reuse should be constructed so that they can be disassembled for cleaning, disinfection, or sterilization.

Non-sterile device packaging systems shall be designed to maintain the intended cleanliness level of products intended to be sterilized prior to use and to minimize the risk of microbial contamination.

EUROLAB assists manufacturers with EN 60601-2-12 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.

Get Offer Now

To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.

Whatsapp