Foreword
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard was proposed by National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of SAC/ TC99 National Technical Committee on Dental Materials and Equipment of Standardization Administration of China.
Introduction
This standard recommends testing methods for fluid dental polymer based adhesives for restoratives Note that the testing methods of bond strength include tensile method and shear method, and either or a combination of them may be selected according to the purpose of the product.
If an adhesive may be bonded to both the enamel and the dentin, bonding tests shall be carried out with enamel and dentin separately.
If an adhesive is bonding between various restorative materials according to the instructions, bond strength tests with shear or tensile method shall be conducted between the teeth (dentin and/or enamel) and the restorative materials (such as resin, ceramic, and metal) or between restorative materials (such as resin-resin, and ceramic-metal) according to the types of restorative materials (resin, ceramic, metal, etc.) specified in the instructions.
This standard does not contain qualitative or quantitative requirements for possible biological hazards, but it is recommended to refer to YY/T 0268 Dentistry - Biological evaluation of medical devices used in dentistry - Part 1: Evaluation and test when evaluating possible biological hazards.
Dental polymer based adhesives for restoratives
1 Scope
This standard specifies the classification, requirements and testing methods of fluid (in liquid form) dental polymer based adhesives for restoratives.
This standard is applicable to fluid polymer based adhesives used for bonding between restoratives or restorative materials with teeth and between restorative materials.
This standard does not include polymer based luting materials specified in YY 1042 Dentistry - Polymer-based filling, restorative and luting materials.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition applies.
GB 6682 Water for analytical laboratory use - Specification and test methods
YY 1042 Dentistry - Polymer-based filling, restorative and luting materials
3 Classification
3.1 Dental polymer based adhesives for restoratives are divided into three classes according to the setting method:
Class I: Materials whose setting is effected by initiator and activator at room temperature (self-curing materials).
Class II: Materials whose setting is effected by application of energy from an external source, such as light (external energy-activated materials).
Class III: Materials that are cured by the application of external energy, and also have a self-curing mechanism present (dual-cure materials).
4 Requirements
4.1 Appearance
When determined in accordance with 6.1, the adhesive shall be a flowing liquid with uniform texture and free of visible impurities.
4.2 Film thickness
When tested in accordance with 6.2, the film thickness shall be no more than 25 μm.
4.3 Bond strength
This standard recommends using shear or tensile method to test the bond strength, and the manufacturer may choose either according to the product characteristics.
4.3.1 Shear bond strength
When tested in accordance with 6.3.4, the shear bond strength between the material (metal, resin, ceramics, etc.) and human/bovine teeth (enamel and dentin), and that between restorative materials (resin-resin, metal-ceramics, etc.) shall not be smaller than the value specified by the manufacturer.
4.3.2 Tensile bond strength
When tested in accordance with 6.3.5, the tensile bond strength between the material (metal, resin, ceramics, etc.) and human/bovine teeth (enamel and dentin), and that between restorative materials (resin-resin, metal-ceramics, etc.) shall not be smaller than the value specified by the manufacturer.
4.4 Sensitivity of Classes II and III adhesives to ambient light
When tested in accordance with 6.4, the materials shall maintain physical homogeneity.
4.5 Working time of Classes I and III materials
When tested in accordance with 6.5, the working time of the materials shall not be less than 60 s.
4.6 Setting time of Classes I and III materials
When tested in accordance with 6.6, the setting time of Classes I and III materials shall not exceed 10 min.
4.7 Biocompatibility
Refer to YY/T 0268.
Foreword i
Introduction i
1 Scope
2 Normative references
3 Classification
4 Requirements
5 Sampling
6 Test methods
7 Packaging, marking and information provided by the manufacturer
Bibliography
