EN ISO 10651-6 Lung Ventilators for Medical Use - Part 6: Standard Test for Home Care Ventilation Assist Devices

Medical Device Tests

EN ISO 10651-6 Lung Ventilators for Medical Use - Part 6: Standard Test for Home Care Ventilation Assist Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 10651-6 testing. EN ISO 10651-6 specifies essential safety and essential performance requirements for home care ventilation assist devices intended primarily for home care use but which can be used elsewhere (e.g. hospitals) for patients suitable for home use.

EN ISO 10651-6 Lung Ventilators for Medical Use - Part 6: Standard Test for Home Care Ventilation Assist Devices

This part of EN ISO 10651 specifies requirements for ventilation assist devices that can be used elsewhere (in healthcare facilities or elsewhere) for patients primarily for home care but not dependent on ventilator support, ie where the ventilator is not vital. These fans are often used where the driving power is unreliable. These ventilators are usually supervised by non-medical personnel with varying levels of training.

This part of EN 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; it also includes certain requirements for reliable operation to ensure safety.

The General Standard has linked the Collateral Standards and the Special Standards. Coverage Standards contain requirements for specific technologies or hazards and are used in medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. Applies to all applicable equipment such as

EUROLAB assists manufacturers with EN ISO 10651-6 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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