ISO 10651-2 Standard Test Method for Lung Ventilators for Medical Use

Medical Device Tests

ISO 10651-2 Standard Test Method for Lung Ventilators for Medical Use

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 10651-2 testing. ISO 10651-2 specifies requirements for home practice lung ventilators for patients dependent on ventilatory support.

ISO 10651-2 Standard Test Method for Lung Ventilators for Medical Use

Such ventilators are considered life support equipment, are often used where driving power is unreliable, and are often supervised by non-medical personnel with varying levels of training.

ISO 10651-2 is designed for use with the general standard IEC 60601-1. ISO 10651-2 does not apply to chest armor and "iron-lung" ventilators.

ISO 10651-2 is not applicable to ventilators that are only intended to enhance ventilation of spontaneously breathing patients.

This part of ISO 10651 is a special standard based on IEC 1 2, including amendments 60601 and 1, hereinafter referred to as the General standard. The general standard is the basic standard for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment, also includes certain requirements for reliable operation to ensure safety.

The general standard has associated collateral standards and specific standards. Coverage standards include requirements for specific technologies or hazards and include medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. It applies to all applicable equipment such as

EUROLAB assists manufacturers with ISO 10651-2 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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