EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 80601-2-12 standard. This standard applies to the basic safety and basic performance of a ventilator with its accessories, hereinafter referred to as ME equipment.
It is designed for use in a specialized care setting for patients whose conditions may be life-threatening and require extensive treatment.
For the purposes of this standard, such an environment is called a critical care environment. For this environment, ventilators are considered life-sustaining. For the purposes of this standard, such a ventilator may be transportable within a professional healthcare facility (ie, a ventilator that can be operated in transit).
A critical care ventilator intended for transport use within a professional healthcare facility is not considered an emergency medical services environment ventilator.
It is designed for patients who are intended to be operated by a healthcare professional and require different levels of support from artificial ventilation, including ventilator dependent patients.
A critical care ventilator is not considered to use a physiological closed-loop control system unless it uses a physiological patient variable to adjust ventilation therapy settings.
This standard also applies to accessories intended by the manufacturer to be connected to the ventilator breathing system or ventilator where the characteristics of these accessories may affect the basic safety or basic performance of the ventilator.
EUROLAB assists manufacturers with EN ISO 80601-2-12 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.
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.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
