Medical devices classifies regulation

stroke, and then medical school interview advice part 1

Medical devices classifies regulation

The first is classification of normative medical devices, basis " medical devices monitors regulation " , draft this regulation.

The 2nd medical devices is to point to: Perhaps combine alone use the instrument at human body, equipment, implemental, data other perhaps goods, include wants software. Its use an end is:

(one) the precaution of the disease, diagnose, cure, custody perhaps alleviates.

(2) the diagnosis of injury or deformity, cure, custody, alleviate or compensate.

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

(4) gravid control. The function that its use within watch of human body body and body is not to use the method of pharmacological, immunology or metabolization to obtain, but the likelihood has these methods to participate in and rise to assist action certainly.

This the 3rd regulation is used at guidance " medical devices classifies catalog " make and decide new product to register a category.

The 4th decides medical devices is classified, the case that should use form and medical devices to use state tripartite face according to the structural feature of medical devices, medical devices undertakes deciding integratedly. What medical devices classifies is specific it is OK to decide according to " medical devices classifies decision table " (see accessory) undertake.

The 5th medical devices classifies decided basis

(one) the structural feature cent of medical devices of feature of structure of medical devices is: Active medical devices and passive medical devices.

(2) use form of medical devices expects an end according to what differ, the use form with proper classify of medical devices. Among them:

The use form of 1. passive appliance has: Medical fluid is carried save appliance; Change blood, humoral appliance; Medical dressing; Surgical appliance; Repeat use surgery appliance; One-time asepsis appliance; Embedded appliance; Use contraceptive and family planning appliance; Disinfect clean appliance; Nurse reagent, other passive contact or passive assistor are diagnosed outside appliance, body instrument. 2. The use form of active appliance has: Energy treats appliance; Diagnostic custody appliance; Carry humoral weapon; Ionization radiate appliance; Lab instrument equipment, medical treatment sterilizes equipment; Other active appliance or active assist equipment to wait.

(3) ground of use state of medical devices is used in the possibility that produces loss to human body, influence to medical treatment effect, medical devices uses a state to cent is a contact or can enter human body appliance and appliance of blame contact human body, specific can divide for:

1. is contacted or enter human body appliance

(1) uses time limit cent to be: Use temporarily; Short-term use; Use for a long time.

(2) contacts the place cent of human body to be: The skin or antrum; Organize inside scar or body; Haemal circulatory system or central nervous system.

(The scathing rate cent that causes after out of control of 3) active appliance is: Slight loss; Injury; Serious injury.

The influence of appliance of human body of 2. blame contact to medical treatment effect, its degree cent is: Do not affect basically; Have indirect effect; Have main effect. The 6th carries out what medical devices classifies to decide principle

(one) classification of executive medical devices, answer to undertake according to classifying decision table.

(2) classification of medical devices decides basically anticipate according to its use purpose and action undertake. If same product uses purpose and effect way to differ, classification should decide respectively.

(3) the medical devices that uses jointly with other medical devices, part of one‘s job does not undertake classified; The accessory of medical devices is classified should depart with the lead plane of its form a complete set, classify alone according to the circumstance of accessory.

(4) action at human body the medical devices of a few place, according to the risk tall use form, use condition undertakes classified.

(5) the software that controls function of medical devices and this medical devices undertake classified according to same category.

(6) if a medical devices is OK and applicable,2 are classified, should accept highest classification.

(7) monitoring or influence medical devices are main functional product, its classification and the classification that are fettersed by monitoring and image Chinese percussion instruments are consistent.

(8) supervisory management board of national medicines and chemical reagents needs according to the job, classify to needing the medical devices that undertakes be supervisoried technically administrative to be able to adjust its.

Medicines and chemical reagents of the 7th country supervises management board to be in charge of medical devices to classify the job. According to " medical devices classifies catalog " when cannot deciding medical devices is classified, supervise management department basis by provincial medicines and chemical reagents " classification of medical devices is regular " undertake be classifieded beforehand,

The meaning of this the 8th regular and following choice of words is:

(one) expect an end: Show product specification, label or propagandist data carry bright, the action that use medical devices ought to obtain.

(2) risk: Bring about human body to get the serious rate of the dangerous happening possibility of harm and harm.

(3) term of service:

1. Temporary: The consecutive use time that appliance expects is in 24 hours of less than;

2. Short-term: The consecutive use time that appliance expects is in 24 hours of above 30 days of less than;

3. Long-term: The consecutive use time that appliance expects exceeds 30 days;

4. Use time continuously: Appliance is pressed expect an end, did not produce the time of action actually discontinuously.

(4) use place and appliance:

1. Blame contactor fetterses: Not direct or the appliance of medical contacts patient;

2. Exterior contactor fetterses: Include the appliance that contacts with the following place:

(1) the skin: Contact only not was damaged the appliance of skin surface;

(2) mucous membrane: With the appliance that mucous membrane contacts;

(3) scathing surface: Express osculatory appliance with cut or other injury body.

3. Surgery invades appliance: Operation of surgery of have the aid of, appliance all or the part invades body through body watch inside, the contact includes the appliance of following place:

(1) hemal: Invade point contact of the some on blood-vessel and hematic road; Regard pipeline as the appliance that inputs to hemal system;

(2) organization / bone / made of ivory: Invade organization, bone and dental pulp / the appliance of system of made of ivory and material;

(3) blood circulates: Contact the appliance of haemal circulatory system.

(5) embedded appliance: Operations of any surgery of have the aid of, appliance perhaps enters human body partly entirely or natural antrum in; Stay for a long time after operation process ends inside body, or these appliance parts stay in at least 30 days of above inside body, these appliance are considered as embedded appliance.

(6) active appliance: Any support electric energy or other the sources of energy is not the medical devices that develop its function directly by the sources of energy of human body or gravitational generation.

(7) repeat use surgery appliance: In showing appliance is used at surgical operation, undertake cutting, cut, auger, curium, catch, blow, clamp, smoke, clip or similar operation procedure, do not connect apparatus of replace He Youyuan, it is OK to pass constant processing the appliance of reuse.

(8) centre circulatory system: Vein of artery of the pulmonary artery in showing human body blood circulates, aorta, coronary artery, carotid, head, heart, go up next big pitch vein, big pitch vein.

(9) central nervous system: Point to cerebrum, meningeal, spinal cord. This the 9th regulation supervises management board to be in charge of explaining by national medicines and chemical reagents.

This the 10th regulation is carried out since April 10, 2000.