YY/T 0518-2009 English PDF (YYT0518-2009)

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YY/T 0518-2009: Dental polymer based adhesives for restoratives
YY/T 0518-2009
Dental polymer based adhesives for restoratives
ICS 11.060.10
C 33
Chinese People's Common Benefit] National Medicine Industry Standards
YY/T 0518-.2009
Polymer-based adhesive for dental restorations
Published on December 30,.2009
2011-06-01 Implementation
Issued by the State Food and Drug Administration
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee for Dental Materials and Devices (SAC/TC 99).
This standard was drafted. Peking University School of Stomatology, Dental Medical Device Inspection Center.
Participated in the drafting of this standard. Heraeus Gusha Dental Co., Ltd.
The main drafters of this standard. Zheng Rui, Lin Hong, Zheng Gang, Zhang Dianyun, Sun Zhihui, Liu Xiaoliang, Li Ying.
This standard recommends the detection method of polymer-based adhesives for dental restorations with fluidity. Among them, the detection method of bonding strength
The method includes a stretching method and a shearing method. Depending on the use of the product, one or two methods can be selected for testing.
If an adhesive can be bonded to both enamel and dentin, enamel and dentin bonding tests should be performed separately.
If the instructions stipulate that there is a bonding effect between the adhesive and various repair materials, the type of repair materials (tree
Moon purpose, ceramic, metal), between teeth (dentin and/or enamel) and restoration materials (eg resin, ceramic, metal), or restoration materials
(Eg. resin-resin, ceramic-metal, etc.) shear or tensile bond strength test.
This standard does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended that when evaluating possible biological hazards,
Please refer to YY/T 0268 "Dental Science Oral Medical Device Biological Evaluation Unit 1. Evaluation and Test"
Polymer-based adhesive for dental restorations
1 Scope
This standard specifies the classification, requirements and testing methods of polymer-based adhesives for dental restorations with fluidity (in liquid form).
This standard applies to fluid-based polymer-based adhesives used in the bonding of restorations or restoration materials to teeth and restoration materials.
This standard does not include polymer-based cementing materials in YY 1042 "Dental science resin-based filling, restoration and cementing materials".
2 Normative references
The clauses in the following documents become the clauses of this standard through the quotation of this standard. For dated references, all subsequent documents
The amendments (not including errata content) or revisions are not applicable to this standard. However, all parties to agreements based on this standard are encouraged
Investigate whether the latest versions of these files can be used. For the cited documents without date, the latest version applies to this standard.
GB 6682 Analysis laboratory water specifications and test methods
YY 1 0 4 2 Dentistry polymer-based filling, restoration and cementing materials
3 Classification
3.1 According to the curing method, it is divided into the following three categories.
Engineering. Materials that cure at room temperature (self-coagulating materials) through initiators and catalysts.
Type n. Materials that are cured by external energy sources such as light (external energy activation materials).
Type m. materials that can be cured by external energy and have a self-coagulating mechanism (dual curing materials).
4 requirements
4.1 Appearance
According to the test of 6.1, the adhesive should be a free flowing liquid with uniform texture and no visible impurities.
4.2 Film thickness
According to the test of 6.2, the thickness of the film should not exceed 25mm.
4.3 Bond strength
This standard recommends the use of shearing or stretching to detect the bonding strength. The manufacturer can choose one of them according to the characteristics of the product.
4.3.1 Shear bond strength
According to 6.3.4 test, between the materials (metal, resin, ceramics, etc.) and human or bovine teeth (enamel, dentin), restorative materials (resin and tree
Grease, metal and ceramic, etc.) the shear bonding strength should not be less than the manufacturer's specified value.
4.3.2 Tensile bond strength
According to the 6.3.5 test, between the material (metal, resin, ceramics, etc.) and human or bovine teeth (enamel, dentin), the restoration materials (resin and resin
The tensile bonding strength between metal and ceramics should not be less than the manufacturer's specified value.
4.4 Sensitivity of E and Melon Adhesives to Ambient Light
According to the 6.4 test, the material should maintain physical uniformity.
4.5 Working hours of Class I and Class I materials
According to 6.5 test, the shortest working time should not be less than 60s.
4.6 Curing time of Class I and EI materials
According to 6.6 test, the longest curing time for materials of class I and class I should not exceed 10 min.
4.7 Biocompatibility
See YY/T 0268.
5 Sampling
Take a sufficient amount of samples from the same batch of products to complete all tests and repeat the necessary tests.
6 Test method
Unless otherwise specified, all tests should be carried out at a temperature (23 ± 2) ° C and a relative humidity (50 ± 5)%. If it is refrigerated
The stored materials should be placed in the test environment at least 24 hours in advance. •
The water used in the test was all Grade 3 water (GB 6682).
6.1 Appearance
Using a pipette or the drip port of the packaging bottle, drop a drop of sample on the slide. Visual observation, the droplets can flow and spread, and the material texture
Uniform, no visible impurities. Then meet the requirements of 4.1.
6.2 Film thickness
Determined according to 7.5 in YY 1042-2003, it shall meet the requirements of 4.2.
6.3 Bonding strength
6.3.1 Equipment and appliances
6.3.1.1 A mechanical testing machine with a crosshead running speed of (0.75 ± 0.30) mm/min is available.
6.3.1.2 Low speed saw;
6.3.1.3 polishing machine;
6.3.1.4 polyester film;
6.3.1.5 Slides;
6.3.1.6 Caliper, accuracy 0.01mm;
6.3.1.7 Loading device with counterweight, counterweight mass lkg.
6.3.2 Teeth preparation and storage
Choose adult anterior teeth or molars without caries or root canal treatment, or 10 bovine mandibular incisors under 5 years of age. Wash under running water to remove soft
To organize, use a low-speed saw to remove the root of the tooth under water cooling and set aside.
Note. The storage period of spare human teeth or bovine teeth is 4
C water is six months, and water needs to be changed regularly during storage to prevent tooth deterioration; half a year in a refrigerator below 5'C. Teeth beyond the storage period cannot be used.
6.3.3 Preparation of samples
Embed the crown with super-hard gypsum or self-setting resin in a tooth fixture (dental cup) with a diameter of 20 mm and a height of 14 mm (Figure 1). Exposed
The cheek (lip) surface of the crown is slightly above the edge of the metal cup. The tooth surface should be kept moist during embedding. Place the tooth cup in the polishing mold (Figure
2) The hole is kept perpendicular to the working surface of the polishing machine. The tooth surface is researched by P300.P500 water sandpaper in turn
Grinding, and finally polished with P600 water sandpaper to obtain a dentinal or dentin plane with a diameter greater than 3mm. The resulting plane is under 2 times magnifying glass
Observation should be flat and smooth.
6.3.4 Shear bond strength
6.3.4.1 Bonding procedure
The tooth surface in the tooth cup was rinsed under running water for 10s, and gently blown with oil-free gas until the surface visible water was removed. According to the instructions
It is required to treat and dry the tooth surface to the degree specified in the instructions. Apply a single-sided tape with a round hole with a diameter of 3 mm to the process
Tooth surface
Necessary). Measure the diameter of the composite resin column with a caliper, and then store the sample in (37 ± 2) ° C water for (24 ± l) h. The test piece is taken from the water
After that, the test should be carried out immediately.
6.3.4.2 Shear strength test
6.3.4.2.1 Appliances
A shear knife with a horizontal cutting edge was used, and the width of the cutting edge was 1 mm (Figure 6).
6.3.4.2.2 Fixing of bonded samples
When fixing the bonding sample, the selected force direction should be consistent with the movement direction of the cutting knife, and ensure that the straight edge of the cutting knife is as close to the bonding
The interface will not touch objects other than the composite resin pillar during the test.
6.3.4.3.3 Detection
The shear strength test is carried out on the universal testing machine, and the shear test instrument is placed between the two parallel tables of the testing machine, and the upper table
Move the shearing knife downward to apply shear to the sample. When the upper table is in contact with the shearing knife, it should ensure that there is no impact on the sample. Shear rate
The degree is 0.75mm/min.
6.3.4.3 Judgment of results.
a) Of the 10 samples, 8 or more than 8 have a measured adhesive strength greater than or equal to the provisions of 4.3.1, which meets the requirements of the standard
b) Of the 10 samples, the measured value of more than 6 of the bonding strength is less than the provisions of 4.3.1, it does not meet the standard requirements;
c) If it is different from the above, the test must be repeated. 10 or more of the 12 samples in the repeated test
If the setting value is greater than or equal to 4.3.1, then it meets the requirements of the standard, otherwise it is considered that it does not meet the requirements of the standard.
6.3.5 Tensile bond strength
6.3.5.1 Preparation of bonding columns (metal, ceramic, resin)
The bonding column uses the pre-formed column provided by the manufacturer with the same composition as the tested product. The diameter of the bonding column is 3mm or 4mm (accurate to
0.01mm), one end is drilled, and the other end is the bonding surface
Silane treatment, etc.). Rinse with running water to ensure that the bonding surface is clean and free of impurities.
6.3.5.2 Preparation of porcelain blocks
Use the ceramic block provided by the manufacturer with the same composition as the product to be inspected.
Treat the bonding surface (such as acid etching, silane treatment, etc.). Rinse with running water to ensure that the bonding surface is clean and free of impurities.
6.3.5.3 Bonding procedure
Rinse the tooth specimen prepared in 6.3.3 (or the ceramic block prepared in 6.3.5.2) under flowing water for 10 s, and blow off the surface with oil-free gas
Visible water. Treat the tooth surface according to the instructions, rinse with running water, and gently blow without oil gas to reach the dryness specified in the instructions.
Apply a single-sided tape with a circular hole with a diameter of 3mm to 4mm to the surface of the treated tooth (or porcelain block)
Apply pretreatment agent and adhesive in sequence. Take the bonding column prepared in 6.3.5.1 and align it with the round hole, place it on the tooth (or porcelain block), and the two bonding surfaces should be tight.
Keep the long axis of the bonding column at 90 ° to the surface of the tooth (or porcelain block), and apply a 1kg mass weight to the bonding column for 10s. H, HI type material solid
At the time of irradiation, the light source is irradiated from different angles close to the bonding surface. After curing, the sample is placed according to the time required by the instructions. Then place the sample in
(37 ± 2) ° C water storage for 24h; or after 37hC water 2 0h ~ 24h, transfer to 5 ° C and 5 5 ° C water bath and circulate 500 cycles, in each
Stay at least 20s at a temperature, and the transfer time between two water baths should not exceed 3s. The test piece shall be tested immediately after being removed from the water.
6.3.5.4 Tensile strength test
The bonding assembly is placed in the tensile fixture of the testing machine, and the tensile load is applied by the metal wire passing through the hole of the bonding column, and the loading speed is (0.75 0.30) mm/min.
6.3.5.5 Results judgment.
a) Of the 10 samples, 8 or more than 8 of which the measured value of bonding strength is greater than or equal to 4.3.2 shall comply with the standard requirements;
b) Of the 10 samples, more than 6 of which have a measured adhesive strength less than 4.3.2, do not meet the standard requirements;
c) If it is different from the above, the test must be repeated. 10 or more of the 12 samples in the repeated test
If the measured value is greater than or equal to the requirements of 4.3.2, it meets the requirements of the standard, otherwise it is considered that the requirements of the standard are not met.
7 6.4 Sensitivity of n-type and HI-type adhesives to ambient light
According to the method of 7.9 in YY 1042-2003, the result should meet the requirements of 4.4.
6.5 Working hours of Class I and IE materials
According to the method of 7.7 in YY 1042-2003, the result should meet the requirements of 4.5.
6.6 Curing time of Class I and DI materials
According to the method of 7.8 in YY 1042-2003, the result should meet the requirements of 4.6.
7 Packaging, identification and information provided by the manufacturer
7.1 Packaging
The material should be packaged in a container or capsule. The container or capsule that is in direct contact with the material should have a protective effect on the material and have no adverse effect on its performance.
To protect containers and capsules, outer packaging can be used.
7.1.1 Outer packaging
Each outer package should clearly indicate the following information.
a) Product name and/or trade name;
b) Name and address of the manufacturer;
c) curing method;
d) Recommended storage conditions;
e) Net mass (g) or net volume (mL);
f) Date of production or batch number;
g) validity period;
7.1.2 Inner packaging
All inner packaging should clearly indicate the following information.
a) Product name and/or trade name;
b) Prod...