The ISO 80601-2-12 standard, developed by the International Standards Organization (ISO), describes the basic safety and performance characteristics and test methods of lung ventilators (respirators) used in intensive care. This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 80601-2-12 Electrical medical equipment - Part 2-12: Specific requirements for the essential performance of basic safety and critical care ventilators.
This standard applies to the basic safety and basic performance of a ventilator that is considered medical equipment, together with its accessories. The ventilators are designed for use in an environment that provides special care for patients who are at risk and require extensive care and continuous monitoring in a professional healthcare facility. However, a critical care ventilator for transport use in a professional healthcare facility is not considered an emergency medical environment ventilator. Ventilators intended to be operated by a healthcare professional operator and designed for patients who need different levels of support from artificial ventilation, including ventilator-dependent patients, fall within the scope of this standard.
This standard is also applied by manufacturers to a ventilator where accessories intended to be connected to a ventilator breathing system or the characteristics of these accessories may affect the basic safety or basic performance of the ventilator.
Hazards specific to the intended physiological function of medical devices or medical systems within the scope of this standard are not covered by the requirements in this standard, except for the IEC 60601-1 standard. This standard also does not include the following ventilators or accessories:
Our organization also provides testing services for lung ventilators (respiratory devices) used in intensive care units, in accordance with ISO 80601-2-12, as part of its laboratory services to businesses .
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