Safety Testing of Ventilators as per: ISO 80601-2-12:2020
Scope of Ventilator Testing as per ISO 80601-2-12:
Intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility. Intended to be operated by a healthcare professional operator intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A ventilator is a machine designed to move breathable air into and out of the lungs, to provide respiration for a patient who is physically unable to breathe, or breathing insufficiently due to illness such as ALS, acute respiratory distress; often used in some surgical procedures and in the ICU. A machine that helps the lungs works. It doesn’t treat any kind of condition or illness. Rather, it may be used during treatment of one.
Other names for a ventilator are:
- Breathing machine
- Mechanical ventilation
Ventilators are used in critical situations and nobody can’t take any risk for safety of this kind of machine we performs worst case testing and performance as per standard because life is very costly.
Main Tests of Ventilator
Main tests done on Ventilator ( ISO 80601-2-12 Testing Lab )
- Protection against electric and Mechanical hazards
- Unwanted AND excessive Radiation Hazards
- Temperature Test
- Leakage current test
- Ingress protection test
- In Put Current
- Interruption in supply
- Protection against hazard output
- Fault Condition
- Environmental Test
- Accuracy of Controls
- Risk management