When the COVID-19 pandemic took hold, so too did the demand for ventilators. With patient safety at its heart, ISO’s committee for respiratory devices rapidly got to work on a new standard to support the manufacture of new, high-quality medical equipment that could help.

Bob Kopotic is a Critical Care Manager of Clinical and Medical Affairs for Edwards Lifesciences. He is a licensed critical care registered nurse and respiratory therapist and members [1] of ISO’s subcommittee ISO/TC 121/SC 3 on respiratory equipment. We are in a period where ventilators are used perhaps more than ever before. Not only are more ventilators of various kinds required, but more medical staff need to be brought up to date with how to use them correctly.

Internationally agreed upon standards such as those offered by ISO not only help manufacturers produce this kind of equipment more quickly and to high levels of quality and performance that comply with all necessary regulations, but they also help to ensure it is used appropriately and as intended. Dr Sandy Weininger m, a Senior Regulatory Engineer in the Center for Devices and Radiological Health at the US Food and Drug Administration (FDA) says Making these ventilator-related standards freely available helps manufacturers to easily incorporate design elements to support safe device construction. It also gives them up-to-date and standardized specifications and information that are well understood and accepted, as well as testing methods to verify performance