YY/T 0518-2009 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0518-2009 | English | 150 |
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Dental polymer based adhesives for restoratives
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YY/T 0518-2009: Dental polymer based adhesives for restoratives---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0518-2009
PHARMACEUTICAL INDUSTRY STANDARD
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
Foreword
This standard was proposed by the China Food and Drug Administration.
This standard shall be under the jurisdiction of the National Standardization
Technical Committee for Dental Materials and Devices (SAC/TC 99).
Drafting organization of this standard. Peking University School of Stomatology,
Dental Medical Device Inspection Center.
Participated drafting organization 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.
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".
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.
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. mm Unit. mm
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
7.1 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.
7.3 The Chinese markings shall comply with the provisions of national
laws and regulations.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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