YY/T 0518-2009Dental polymer based adhesives for restoratives (English PDF)
牙科修复体用聚合物基粘接剂
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0518-2009 is the English-translated version of 牙科修复体用聚合物基粘接剂.
YY/T 0518-2009 is the Chinese pharmaceutical industry standard for the polymer based adhesives used with fluid dental restorative materials, those supplied in liquid form.
It classifies these adhesives and sets the requirements for them together with the test methods, covering the bond strength to enamel and to dentine, the film thickness, the working and setting behaviour, the water sorption and the shelf life, and the information supplied with the product. Issued on 30 December 2009, it has applied since 1 June 2011.
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Document preview — YY/T 0518-2009
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- Introduction4
- 1 Scope5
- 2 Normative references5
- 3 Classification5
- 4 Requirements6
- 5 Sampling7
- 6 Test method7
- 7 Packaging, labeling, information provided by the manufacturer13
- References15
Introduction
This standard recommends the testing method of polymer-based adhesives for dental restorations with fluidity. Among them, the testing method of the bonding strength includes a stretching method and a shearing method. Depending on the use of the product, it may select one or two methods testing.
If an adhesive can be bonded to both enamel and dentin, enamel and dentin bonding tests shall be performed, respectively.
If the instructions stipulate that there is a bonding effect between the adhesive and various restoration materials, it shall follow the types of restorative materials as specified in the instruction manual (resin, ceramic, metal), to perform the shearing or tensile bonding strength test between the teeth (dentin and / or enamel) and restorative materials (such as. resin, ceramic, metal), or between restorative materials (such as. resin-resin, ceramic-metal, etc.).
This standard does not contain qualitative and quantitative requirements for possible biological hazards. However, it is recommended that when evaluating possible biological hazards, please refer to YY/T 0268 "Dentistry - Biological evaluation of medical devices used in dentistry - Part 1: Evaluation and test".
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.
4 Requirements
4.1 Appearance
When tested according to the 6.1, the adhesive shall be a free-flowing liquid with uniform texture and no visible impurities.
4.2 Film thickness
When tested according to the 6.2, the thickness of the film shall not exceed 25 µm.
4.3 Bonding strength
This standard recommends the use of shearing or tensile method to test the bonding strength. The manufacturer can choose one of them according to the characteristics of the product.
4.4 Sensitivity of type II and III adhesives to ambient light
When tested according to the 6.4, the material shall maintain physical uniformity.
4.5 Working hours of type I and II materials
When tested according to the 6.5, the shortest working time shall not be less than 60 s.
4.6 Curing time of type I and II materials
When tested according to the 6.6, the longest curing time of the type I and III materials shall not exceed 10 min.
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).
6.2 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.
6.3.2 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 with running water to remove soft tissues; use a low-speed saw to remove the root of the tooth under water cooling, to prepare for use.
6.3.4 Shear bonding strength
6.3.4.1 Bonding procedure
The tooth surface in the tooth cup is rinsed by running water for 10 s, meanwhile gently blown by oil-free gas, until there is no visible water at surface. Treat and dry the tooth surface according to the instructions to the extent specified in the instructions. Apply a single-sided adhesive tape which has a round hole with a diameter of 3 mm to the surface of the treated tooth; apply the pretreatment agent and adhesive in the holes in sequence according to the instructions and Unit.
6.3.4.3.3 Testing
The shear strength test is carried out on a universal testing machine. The shear test equipment is placed between the two parallel benches of the testing machine. The upper bench moves the cutting blade downward to apply a shearing effect to the specimen. When the upper bench is in contact with the cutting knife, it shall ensure that there is no impact on the specimen. The cutting speed is (0.75 ± 0.30) mm/min.
6.3.5.5 Results judgment
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
7.3 The Chinese markings shall comply with the provisions of national laws and regulations.
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.
7.1.1 Outer packaging
Each outer package shall clearly indicate the following information.
7.1.2 Inner packaging
All inner packaging shall clearly indicate the following information.
7.2 Product's instruction manual
The product's instruction manual shall be accompanied by at least the following information. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
YY 1042-2003 — Dentistry - Polymer-based filling, restorative and luting materials
YY 1042-2011 — Dentistry—Polymer-based restorative materials
YY 1042-2023 — Dentistry - Polymer-based restorative materials
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