National Health and Health Commission issued the standard of medical device grade

Recently, the official website of the national health and Health Commission released the industry standard of medical device safety management The classification and risk classification of medical devices are detailed At present, many large-scale high-risk and medium-risk medical devices have been widely used in medical institutions in China, not only in large-scale tertiary hospitals, but also in secondary hospitals and even primary medical and health institutions, which has become an important basic guarantee to promote and improve the level of medical technology It is worth noting that any inaccuracy and deviation of the technical performance and state parameters of medical devices in the clinical use process may affect the medical quality to varying degrees, causing injury or even death to personnel According to the relevant national laws and regulations, the standard preparation group studies and analyzes the actual situation of the safety management of medical devices used in clinical practice in China, summarizes the practical experience, and formulates the standard based on widely soliciting the opinions of all parties The message states that the defined medical device and the following terms and definitions apply to this document The concept of medical devices refers to the diagnosis, treatment, monitoring, mitigation and compensation of diseases, injuries or disabilities; Research, replacement and regulation of anatomical or physiological processes; control of pregnancy; The purpose of the examination of human body samples is not to obtain its function on the body surface or in the body by means of pharmacology, immunology or metabolism (but these means may participate in and play a certain auxiliary role) The general term of the instruments, equipment, appliances, materials or other articles, including the required software, which are used in the human body alone or in combination Classification of high risk medical devices Classification of medium risk medical devices Classification of low risk medical devices