New standard for Covid ventilators
With the outbreak of the pandemic, the demand for Covid ventilators increased. In this regard, the topic of patient safety, but also standards, plays an important role.
Those who are hit hard by the virus and have to be hospitalized are not infrequently also connected to a ventilator. Against the background of patient safety, ISO's "Technical Committee 121 / Subcommittee 3 on Ventilators" has set about drawing up a standard for the manufacture of new, reliable and high-quality medical ventilators, as the Swiss Standards Association (SNV) writes.
Still available this year
The standard "ISO/DIS 80601-2-90 Medical electrical equipment - Part 2-90: Particular requirements for the safety and essential performance of high flow ventilatory therapy equipment". is in the works and is expected to be made available later this year, according to SNV. The ISO has worked with two experts - members of the ISO Subcommittees ISO/TC 121/SC 3 for ventilators - talked about the role of the above and other related standards in the current crisis and what they can do.
"Not only are more ventilators of various types needed, but more medical professionals need to be trained on how to use them properly," said expert Bob Kopotic, critical care manager in the clinical and medical affairs division at Edwards Lifesciences, in the Interview, which is published on the SNV website. International standards such as those of the ISO would support manufacturers in producing such devices more quickly and with high quality and performance. It is important that they also comply with the necessary regulations. However, standards would also help to ensure that the equipment is used correctly and for the intended purpose, Kopotic continued.
Sandy Weininger, Senior Regulatory Engineer in the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA) and member of the ISO subcommittee, also emphasizes in an interview: "If these relevant standards for ventilators are freely available, manufacturers can use them to design their devices more safely. It also gives them up-to-date and standardized technical data and information that is widely understood and accepted, as well as test methods to verify performance."
Standards for ventilators
Those who are severely ill with Covid-19 may need artificial respiration, depending on the course of the disease. The SNV offers a selection of valid SN standards for ventilators (cf. here).
Source: SNV / rs
