What are Class I Medical Devices?
Class I medical devices refer to medical instruments with low risk levels that can guarantee their safety and effectiveness through routine management. These medical devices typically do not directly invade the human body during use, or have brief contact with the human body, posing a relatively small potential risk to the human body. For instance, surgical knives, medical cotton swabs, bandages, and thermometers all belong to Class I medical devices.
What are the main purposes of Class I medical devices?
Diagnostic Uses: For instance, a thermometer is used to measure body temperature, aiding in the diagnosis of fevers and other illnesses.
Therapeutic Uses: A bandage, for example, is used to wrap wounds, promoting healing and recovery.
Preventive Uses: Protective masks, for instance, are used to prevent the spread of respiratory infectious diseases.
Assistive Uses: Devices such as wheelchairs and hearing aids serve as assistive equipment, helping patients or individuals with disabilities to improve their quality of life.