What is active medical device and passive medical device

Active medical devices, according to the product characteristics of the distinction between a medical device, any rely on electricity or other energy sources, rather than directly by the human body or gravity to produce energy, to play its function of medical devices. In addition to active medical devices, there are passive medical devices and in vitro diagnostic reagents.

Passive medical devices refer to medical devices that do not rely on any electrical or other energy sources, but are directly generated by the human body or gravity to perform their functions.

Expanded Information

Passive medical devices do not produce harmful side effects even after being used in the human body and are able to perform during the design life of the passive medical device. This includes three aspects: first, the safety of the patient, from time to time can have a near-term or long-term safety; second, the safety of medical personnel and operators; in addition to the safety of the surrounding environment.

Active contact with the human body devices: energy therapy devices, diagnostic and monitoring devices, liquid delivery devices, ionizing radiation devices, implantable devices, other active contact with the human body devices.

Active non-contact human devices: clinical testing instruments and equipment, independent software, medical device sterilization equipment, other active non-contact human devices.

Baidu Encyclopedia - Passive Medical Devices

Baidu Encyclopedia - Active Medical Devices