FAN SAFETY MUST BE GUARANTEED FOR THEM TO BE MARKETED
In the case of lung ventilators and used safely, they must be in accordance with a number of requirements, including those related to electrical safety or electromagnetic compatibility (EMC). THE ISQ carries out CEM tests, which are essential to ensure the proper functioning of the ventilators, preventing them from suffering or causing interference in other medical-hospital equipment and systems. The Covid-19 pandemic has challenged the market in the production and development of pulmonary ventilators to meet the demand for these equipments. Medical ventilators allow an automatic and controlled way to force air into and out into the lungs in order to adequately oxygenate a patient's body. Pedro Matias, President of ISQ explains, however, that "in order for ventilators to be purchased and used safely, either by patients or by medical personnel, compliance with applicable safety requirements must be ensured by the assumption of the CE marking on the product." Since CE marking is a requirement for the placing on the market and for the free movement of medical devices on the European market, ISQ may carry out tests in accordance with ISO 60601-2-12 or ISO 80601-2-80 standards, which define the conditions that must be guaranteed at the level of fan-specific safety. Among other tests and evaluations necessary, it is also emphasized those of Electromagnetic Compatibility (EMC) that are fundamental to ensure the proper functioning of the ventilators, preventing them from suffering or causing interference in other medical-hospital equipment and systems. ISQ has IPAC-accredited laboratories including electromagnetic compatibility, with the ability to plan, test and report tests on components, systems and technical units. The CE Marking is indicative of mandatory compliance for various products marketed in the European Economic Area.