ISO 80601-2-12 Medical Electrical Equipment - Special Requirements for Essential Safety and Essential Performance of Critical Care Ventilators

This standard applies to the basic safety and basic performance of a ventilator with its accessories, hereinafter referred to as ME equipment.

• 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;
• Intended to be operated by a healthcare professional;
• It is designed for patients who require different levels of support from artificial ventilation, including ventilator dependent patients.

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

This standard does not apply to ME equipment or ME system operating in a ventilator-operational mode for patients not solely dependent on CVC.

This standard does not apply solely to ME equipment intended to increase the ventilation of spontaneously breathing patients in a professional healthcare facility.

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