1 Scope
This Part of CFDAB/T 0102 specifies basic terminologies related to medical devices required for food and drug administration informatization.
This Part is applicable to food and drug administration informatization work at such stages as design, development, construction and implementation as well as management and maintenance.
2 Basic Terminologies of Medical Devices
2.1 Medical devices
Apparatus, equipment and appliances that separately or jointly used on human body, in vitro diagnostic reagents, calibrators and materials as well as other similar or relevant articles, including softwares required.
2.2 Provisions for medical device classification
The rules established by the food and drug administration department according to relevant laws and regulations to regulate the medical device classification, putting forward the judgment basis of medical device classification and judgment principle for its implementation.
2.3 Active medical devices
Medical device that exert their function relying on electric energy or other energy rather than the energy directly generated by human body or gravity.
2.4 Passive medical devices
The medical devices that exert their function relying on the energy directly generated by human body or gravity instead of any energy or other energy.
2.5 Class I medical devices
Foreword I
1 Scope
2 Basic Terminologies of Medical Devices
References
English Index
Chinese Index
