CFDA publishes new guidelines for ultrasonic bone densitometer and ear cavity type medical infrared thermometer
John Li 2017-11-17 2017-11-27
CFDA has published new guidelines for the registration and evaluation of 5 types of medical devices.
- ultrasonic bone densitometer
- electric wheel chair
- ear cavity type medical infrared thermometer
- medical suction equipment (2017)
- small molecular sieve oxygen generators (2017)
|Ultrasound Bone Sonometers Registration Guidelines
||This guideline applies to class II Ultrasound Bone Sonometers of the ultrasonic physiological parameter measurement and analysis equipment. It test through the ultrasound speed (sos) and/or wide-band ultrasonic attenuation (BUA) of heel bone, tibia and/or radius to reflect the skeletal density condition|
|Electric Wheelchairs Registration Guidelines
||This guideline applies to class II Electric Wheelchairs that are powered by electric energy only by taking 1 person and the user with no more than 100 kg of disability or no complete walking ability.
Not apply to: The electric Wheelchairs more than 100 kg, but it can use the ISO 7176 as a reference. This guiding principle does not apply to manual wheelchairs and electric vehicles powered by electricity.
|Ear Cavity Type Medical Infrared Thermometer Registration||This guideline applies to the infrared temperature sensor is used to measure the infrared radiation exchange and proper correction of the human ear cavity. The output shows the ear cavity type medical infrared thermometer that is measured in a certain part of the human body.|
|Medical Suction Equipment Registration Guidelines (2017 revised version)
||This guideline applies to class II medical vacuum suction device that confirmed to YY0636, including electric suction device, artificial drive suction device, and negative pressure source as the power to attract equipment.
Not apply to: Terminal piece (suction tube and suction head)
|Small Molecular Sieve Oxygen Generator Registration Guidelines (2017 revised version)
||This guideline applies to the small molecular sieve oxygen generator for oxygen-rich air (93% oxygen) or medical oxygen (oxygen generator) as class II medical devices.
Not apply to: Vehicle-mounted medical oxygen generator, medical oxygen machines used in flammable anesthetic gases and/or cleaning agents or medical oxygen machine that supplies gas to a number of patients through a pipeline of medical gases.