The international standard for high-flow respiratory therapy equipment (standard number: ISO 80601-2-90:2021) proposed by BMC Medical standardization technical experts has been formally released recently on the official websites of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). According to the information released by the National Medical Products Administration, it is the first international standard project proposed and completed by China in terms of the medical equipment for the prevention and control of COVID-19.
As project leader, Chen Xingwen from BMC Medical standardization technical expert group pointed out that during the development of the project, a standard drafting team composed of domestic experts did a lot of preparation work, including the investigation on the various problems and the safety protection scenarios that might be involved in the clinical use of the high-flow respiratory therapy equipment in the early stage of the project. During the standard formulation process, the standard drafting team relied on the domestic Respiratory Anesthesia Equipment Standardization Technical Committee convened the experts from relevant domestic enterprises, testing institutions and the National Review Center to discuss the standard coverage and the special requirements of equipment for ensuring safety and effectiveness. The formulation of the entire standard reflects the latest technical development level.
The release of the standard not only fills the gap in the international standards for such products and improves the international standard system in the field of anesthesia and respiratory equipment, but also plays a positive role in ensuring the safety and effectiveness of high-flow respiratory therapy equipment and promoting international circulation, especially providing technical support and contributing Chinese wisdom to global pandemic prevention and control. The release of the standard reflects the recognition by the International Organization for Standardization to the formulation of international standards by China. It also proves the improvement of technical innovation capacity of China and the brand strength and the industry position of BMC Medical in the field of medical equipment.
Reference
The International Safety Standards Led and Formulated by China in the Field of High-flow Respiratory Therapy Equipment Released - National Medical Products Administration
