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

This standard specifies the classification, requirements and testing methods of polymer-based adhesives for fluid restoratives (in liquid form) for dental restorations. This standard applies to fluid polymer-based adhesives used in the bonding of restoratives or restoration materials to teeth and between restoration materials.

YY/T 0518-2009
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.10
C 33
Dental polymer based adhesives for restoratives
ISSUED ON: DECEMBER 30, 2009
IMPLEMENTED ON: JUNE 01, 2011
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Classification ... 5
4 Requirements ... 6
5 Sampling ... 7
6 Test method ... 7
7 Packaging, labeling, information provided by the manufacturer ... 13 References ... 15
Dental polymer based adhesives for restoratives
1 Scope
This standard specifies the classification, requirements and testing methods of polymer-based adhesives for fluid restoratives (in liquid form) for dental restorations.
This standard applies to fluid polymer-based adhesives used in the bonding of restoratives or restoration materials to teeth and between restoration materials. This standard does not include polymer-based luting materials in YY 1042 "Dental science - Resin-based filling, restorative and luting materials". 2 Normative references
The provisions in following documents become the provisions of this Standard through reference in this Standard. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard; however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB 6682 Water for analytical laboratory use - Specification and test methods YY 1042 Dentistry - Resin-based filling, restorative and luting materials 3 Classification
3.1 According to the curing method, it is divided into the following three types: Type I: Materials that cure at room temperature (self-coagulating materials) through initiators and catalysts.
Type II: Materials that are cured by external energy sources such as light (external energy activation materials).
Type III: Materials that can be cured by external energy and have a self- coagulation mechanism (dual curing materials).
See YY/T 0268.
5 Sampling
Take a sufficient amount of samples from the same batch of products to
complete all tests and the necessary repeated tests.
6 Test method
Unless otherwise specified, all tests shall be carried out under the conditions of temperature (23 ± 2) °C and relative humidity (50 ± 5)%. If it is stored in cold storage, it shall be placed in the test environment at least 24 hours in advance. The water used in the test is grade III water (GB 6682).
6.1 Appearance
Use a pipette or the drop port of the packaging bottle, to add a drop of sample on the slide. If visual observation shows that the droplets can flow and spread, the material texture is uniform, without visible impurities, it meets the requirements of 4.1.
6.2 Film thickness
When 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 It provide a mechanical testing machine with a crosshead running speed of (0.75 ± 0.30) mm/min.
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, which has a precision of 0.01 mm;
6.3.1.7 Loading device with counterweight; the counterweight mass is 1 kg. 6.3.2 Teeth preparation and storage
P - The maximum load applied, N;
d - Bonding diameter, mm.
6.3.4.3 Results judgment:
a) In 10 specimens, if 8 or more than 8 of them have a measured bonding strength greater than or equal to the provisions of 4.3.1, it meets the requirements of the standard;
b) In 10 specimens, if more than 6 of them have measured bonding strength less than 4.3.1, it does not meet the standard requirements;
c) If it is different from the above, the test must be repeated. If 10 or more of the 12 test specimens in the repeated test have a measured bonding
strength greater than or equal to 4.3.1, it meets the requirements of the standard, otherwise they will be deemed not to meet the requirements of the standard.
6.3.5 Tensile bonding strength
6.3.5.1 Preparation of bonding columns (metal, ceramic, resin)
The bonding column uses the pre-formed column as provided by the
manufacturer with the same composition as the product to be tested. The diameter of the bonding column is 3 mm or 4 mm (accurate to 0.01 mm). One end is drilled, whilst the other end is the bonding surface. According to the requirements of the manufacturer, the bonding surface of various types of columns is processed (such as sandblasting, acid etching, silane treatment, etc.). Use running water to rinse it, to ensure that the bonding surface is clean and free of impurities.
6.3.5.2 Preparation of porcelain blocks
Use the ceramic block (10 mm x 10 mm x 3 mm) provided by the manufacturer with the same composition as the product to be tested. Process the bonding surface of the ceramic block according to the requirements of the manufacturer (such as acid etching, silane treatment, etc.). Use running water to rinse it, 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 porcelain block prepared in 6.3.5.2) under running water for 10 s. Use oil-free gas to blow off the visible water on the surface. Treat the tooth surface according to the instructions; rinse with running water; gently blow it by the oil-free gas, to reach the dryness specified in the instructions. Apply a single-sided tape with a circular hole which has a diameter of 3 mm ~ 4 mm to the surface of the treated tooth (or porcelain 6.4 Sensitivity of type II and III adhesives to ambient light
Perform test according to the method of 7.9 in YY 1042-2003; the result shall meet the requirements of 4.4.
6.5 Working hours of type I and III materials
Perform test according to the method of 7.7 in YY 1042-2003; the result shall meet the requirements of 4.5.
6.6 Curing time of type I and III materials
Perform test according to the method of 7.8 in YY 1042-2003; the result shall meet the requirements of 4.6.
7 Packaging, labeling, information provided by the
manufacturer
7.1 Packaging
The material shall be packed in a container or capsule. The container or capsule in direct contact with the material shall have a protective effect on the material and have no adverse effect on its performance.
To protect containers and capsules, it may use outer packaging.
7.1.1 Outer packaging
Each outer package shall 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 shall clearly indicate the following information: