ISO 80601-2-87 Medical Electrical Equipment - Testing for Basic Safety of High Frequency Ventilators

EUROLAB, together with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 80601-2-87 testing. This standard, hereinafter referred to as ME equipment, together with its accessories, provides the basic safety and security of a high frequency ventilator (HFV). It applies to basic performance.

It is intended for use in a specialized care setting for patients who may be life threatening and may require extensive care and ongoing monitoring in a professional healthcare facility.

For the purposes of this standard, such an environment is called a critical care environment. High-frequency fans for this environment are considered life-sustaining.

For the purposes of this standard, such a high frequency ventilator may provide transport within a professional healthcare facility (ie, a ventilator that can be operated in transit).

A high frequency ventilator intended for transport within a professional healthcare facility is not considered a ventilator designed for the emergency medical services environment .

There are three basic definitions of HFV:

• High frequency percussion ventilation [HFPV, typical HFV frequency (60 to 1000) HFV inflation/min];
• High frequency jet ventilation [HFJV, typical HFV frequency (100 to 1500) HFV inflation/min]; and
• High frequency oscillatory ventilation [HFOV with a typical HFV frequency (180 to 1200) HFV inflation/min and typically an active expiratory phase].
• In addition, HFV designations may be combined with or with aeration at rates less than 150 inflation/min.

A high frequency ventilator is not considered a physiological closed loop control system unless it uses a physiological patient variable to adjust ventilation therapy settings .

This standard also applies to accessories that are intended by their manufacturers to be connected to an HFV breathing system or a high-frequency ventilator, where the characteristics of these accessories may affect the essential safety or essential performance of the high-frequency ventilator.

EUROLAB assists manufacturers with ISO 80601-2-87 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.