A kind, 2 kinds, the distinction of 3 kinds of medical devices

F.D.N.Y. Close Up - Emergency Medical Service

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A kind, 2 kinds manage a category with 3 kinds of term, see medical devices supervise regulation to have relevant regulation. Tubal reason is small arrive tall. Medical devices, it is to point to perhaps combine alone use the instrument at human body, equipment, implemental, data other perhaps goods, include the software of a need; The function that its use within watch of human body body and body is not to use the method that pharmacological, immunology perhaps metabolizes to obtain, but the likelihood has these methods to participate in and have certain auxiliary effect; Its use aim to achieve following expect an end:

(one) the precaution to the disease, diagnose, cure, custody, alleviate;

(2) right injure or the diagnosis of deformity, cure, custody, alleviate, compensation;

(3) right anatomize or the research of physiology process, replace, adjust;

(4) gravid control.

Cent of medical devices is 3 kinds:

The first kind is to point to, through convention management enough assures the medical devices of its security, effectiveness.

The 2nd kind is to point to, to its security, effectiveness ought to try pilot medical devices.

The 3rd kind is to point to, embedded human body; Use at support, maintain life; Have potential risk to human body, to its security, effectiveness must strict pilot medical devices.

A kind of medical devices has:

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Fundamental surgery uses a knife " scalpel handle and razor blade, skin piece knife, verrucous body comes off rough cutter of knife, Liu Xie knife, moldboard, shave, scurfy drawknife, carry knife of knife of knife, sharp edge knife, pedicure, Xiu Jia, scalpel to wait "

The 2nd kind of medical devices:

(one) common examine appliance kind (6820) : Thermometer, tonometer;

(2) physical cure and rehabilitation equipment kind (6826) : Magnetism cure is implemental;

(3) clinical examine analytic instrument kind (6840) : The family uses blood sugar analyzer and test paper;

(4) equipment of room of surgery, emergency treatment, consulting room and appliance kind (6854) : Medical and small-sized the machine that make oxygen is portable aerobic generator;

(5) medical and wholesome material and dressing kind (6864) : Kuang Yong pledget, medical absorbent gauze;

(6) medical high polymer material and make category (6866) : Condom, contraceptive cap.

The 3rd kind of medical devices:

One, medical devices of one-time use asepsis

1, injector of one-time use asepsis;

2, one-time use infusion implement;

3, one-time use blood transfusion implement;

4, bag of puncture of one-time use anaesthesia;

5, needle of infusion of one-time use vein;

6, needle of inject of one-time use asepsis;

7, one-time use plastic blood bag;

8, one-time use collect blood implement;

9, one-time use burette type infusion implement.

2, orthopaedics is embedded content medical devices

1, false body of joint of surgical and embedded content;
2, set a broken bone of metallic straight form, abnormity board;

3, staple of metallic set a broken bone, correct;

4, metallic orthopaedic uses a stick;

5, the needle inside pith, spicula;

6, equipment is secured inside rachis.

3, stuff stuff
1, mammary stuff stuff;
2, stuff of the stuff inside the eye;
3, orthopaedics stuff stuff.
4, embedded sex medical devices
1, artificial crystal;
2, artificial heart valve;
3, the rich since the heart implement;
4, the conduit inside blood-vessel and bracket.
5, corneal plasticity lens
6, the baby develops case
7, serous and detached cup, serous pipeline
8, hollow fiber dialyzer