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These inconspicuous things are all medical devices?

2020-03-03 11:40:29
Times

1. Take you to know the medical equipment

Medical devices refer to the instruments, equipment, instruments, in vitro diagnostic reagents, calibrators, materials other related articles directly indirectly used for human body, including the required computer software; their effectiveness is mainly obtained by physical means, by pharmacology, immunology metabolism, they only play an auxiliary role although they are involved in them ; the purpose is to:

① Diagnosis, prevention, monitoring, treatment remission of disease.

② Diagnosis, monitoring, treatment, remission functional compensation of injury.

③ Examination, replacement, regulation support of physiological structure physiological process.

④ The support maintenance of life.

⑤ Pregnancy control.

⑥ To provide information for medical diagnostic purposes by examining samples the human body.

These inconspicuous things are all medical devices?

In China, all products defined as medical devices need to be supervised by the market supervision management department in accordance with the regulations on supervision management of medical devices. According to the risk level of using medical devices, China divides them into three categories for management:

One is the low risk level, the implementation of conventional management can ensure its safety effective medical devices.

The second type is a kind of medical device with moderate risk, which needs strict control management to ensure its safety effectiveness.

The third type is a kind of medical device with high risk, which needs to take special measures to strictly control manage to ensure its safety effectiveness.

2. What are the common medical devices in life?

In our daily life, the vast majority of the medical devices we use are class I medical devices a small number of class II medical devices, as well as the very other class III medical devices.

① Equipment that can be bought in the drugstore

Such as band aids, bandages, cotton swabs, cotton sticks, cotton balls, etc., these belong to a class of medical devices.

There are also some thermometers, sphygmomanometers, home blood glucose meters, blood glucose strips, pregnancy diagnosis strips (early pregnancy test strips), ovulation test strips, etc., which belong to the second type of medical devices.

These inconspicuous things are all medical devices?

② Ophthalmic related devices

Contact lenses their care fluid belong to the third category of medical devices, which are also high-level medical devices in daily life.

In addition, eye related products include vision chart, children's graphic vision card, etc., which belong to a class of medical devices.

It should be noted that the liquid crystal vision table belongs to the second category of medical devices in the classification catalog of medical devices.

③ Rehabilitation equipment

·Crutches: belong to a class of medical devices. Including axillary crutches, medical crutches, elbow crutches, walking aids, walking aids, standing stands, paraplegic walking aids, standing balance training aids so on.

·Hearing aids: belong to the second category of medical devices. An electronic device usually used to amplify sound compensate for hearing loss.

·Wheelchair: it belongs to the second category of medical devices. It is used for transport walking function compensation of patients with mobility disorder.

These inconspicuous things are all medical devices?

④ Beauty instrument

For example, the tools for making ear holes belong to passive surgical instruments, surgical instruments - puncture guides, in the classification catalog of medical instruments. It belongs to a class of medical devices.

⑤ Denture instruments

According to different materials, the level in the medical device classification catalog is also different.

Denture metal materials products belong to the second class of medical devices.

Ceramic materials products for denture belong to the second category of medical devices.

According to the main components, some of the polymer materials products for denture belong to the second category some belong to the third category.

⑥ Other devices

Condom, common is the second kind of medical equipment, there are a few third kind of medical equipment.

reference material:

1. Guangdong food Drug Administration: "these obscure things are all medical devices? "

2. Medical device safety knowledge reader


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