1. The products shall be manufactured according to the patient's dental model provided by the clinical dentist and the drawings and design documents approved according to the prescribed procedures.
2. The products shall be manufactured in accordance with the design requirements of the dental clinician. The materials used in the production of the product must be approved by the state registration of dental material products or medical products. The base metal used should be made of dental specialty metals and alloys in accordance with YY 0620, YY 0621 and YY 0626, and the ceramics should be in accordance with the requirements of YY 0716.
The materials of the base brackets or dentures composing the products shall conform to the provisions of YY 0270, YY 0300 or other relevant standards. 1. The external form of the product shall have the basic features of the normal anatomy of the tooth in human physiology, and basically conform to the principles of personalized restoration and bionic restoration.
2. The shape and size of the product should match the tooth of the same name, i.e., the shape of the tooth model provided by the medical institution and the model design unit shown in the requirements.
3. The contact area between the adjacent surface of the product and the neighboring tooth should be consistent with the contact area of the normal tooth of the same name.
4. The occlusal surfaces of the product should have contact points and there should be no occlusal barriers.
5. The product should be free of cracks and bubbles when observed with the naked eye, and there should be no air holes or impurities inside.
6. The surface of the product (except for the fixing part) should be smooth and glossy, without air holes, cracks, shrinkage pits, pits and burrs, and there should be no residual gypsum on the surface of the organization.
7. The product shall not have irritating odor, the resin base bracket shall not have porosity and cracks visible to the naked eye, and the casting of the base bracket, connector and ring shall be free of porosity, impurities, and shall not have white spots. 1. Test equipment
Universal testing machine or other force application device. The error shall not exceed ±1%.
2. Specimen Preparation
3 pairs of the same type and color.
3. Test procedure
Fix both ends of the denture through the model, apply 100N pressure smoothly from the middle of the occlusal surface downward and keep the constant force for 2min, unload and remove the specimen.
With normal visual observation, the specimen shall comply with the provisions of Article 4.6. Product packaging should have the following signs:
a) the name of the manufacturer, address, telephone;
b) product name, applicable teeth;
c) quantity, number (or batch number);
d) date of manufacture;
e) medical device product registration certificate number.
f) Medical device manufacturer license number;
g) Adoption of standards;
h) Instructions for product use;
i) "Fragile items" and other words or symbols, the sign should be consistent with the provisions of GB/T 191 and YY/T 0466.1. 1.2.1 Packaging
The products are wrapped and packaged in neutral bubble plastic film and then packed in self-sealing or other structured plastic bags, which shall be sealed. It should be ensured that the product is not damaged during normal handling and storage.
Note: Other packaging methods as specified in the contract are permitted.
1.2.2 Certificate of Conformity
Each package shall be accompanied by an inspection certificate.
The inspection certificate should have the following contents:
a) product name, number (or batch number);
b) the name of the manufacturer;
c) the date of inspection;
d) the name or code of the inspector. Each batch of products shall be accompanied by the corresponding fitting record card, the contents of which shall include:
a) basic information of the patient (at least the name, tooth position, etc.);
b) basic information of the product (at least the tooth position, material, etc.);
c) basic information of the medical institution (at least the name, address, telephone number, doctor's name, etc.);
d) basic information of the manufacturing enterprise (at least the name, address, phone number, doctor's name, etc.);
d) name or code of the inspector. Basic information of enterprises (at least it should include name, address, service telephone number, etc.). The terminology of the instruction manual should be in line with the provisions of GB/T 6387-1998, GB/T 9937-1998, GB/T 9938-1998 and so on.
The contents of the instruction manual shall conform to the requirements of GB/T 9969.1 and the Administrative Provisions for the Instruction Manual of Medical Devices. The products should be stored in room temperature, dry (relative humidity not more than 85% RH), ventilated, clean place.