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YY 0270.1-2011 English PDF (YY0270.1-2011)

YY 0270.1-2011 English PDF (YY0270.1-2011)

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YY 0270.1-2011: Dentistry. Base polymers. Part 1: Denture base polymers

YY 0270.1-2011
Dentistry.Base polymers.Part 1. Denture base polymers
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
YY 0270.1-2011/ISO 20795-1.2008
Replacing YY 0270-2003, YY 0768-2009
Dentistry base polymer
Part 1. Denture base polymer
(ISO 20795-1.2008, IDT)
Published on.2011-12-31
2013-06-01 implementation
State Food and Drug Administration released
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Category 3
5 Requirements 3
5.1 Unpolymerized material 3
5.2 Aggregated material 3
6 sampling 5
7 sample preparation 5
7.1 Test environment 5
7.2 Step 6
7.3 Special equipment 6
8 Test method 6
8.1 Visual inspection 6
8.2 Packing plasticity 6
8.3 color 8
8.4 Color stability 8
8.5 Polishing properties, translucency, void free, ultimate flexural strength and flexural modulus of elasticity 10 8.6 Determination of fracture toughness by modified bending test 13
8.7 Bonding to synthetic polymer teeth 17
8.8 Residual methyl methacrylate monomer 18
8.9 Water absorption and dissolution value 22
9 Requirements for labels, signs, packaging and instructions provided by the manufacturer 23 9.1 Packing 23
9.2 Markings for outer packaging and containers 24
9.3 Product Instruction Manual 24
Appendix A (Normative) High-pressure liquid chromatography for MMA content 26 Reference 28
YY 0270.1-2011/ISO 20795-1.2008
Foreword
All technical content in this section is mandatory.
YY 0270 "Dental Base Polymer" includes the following two parts.
---Part 1. Denture base polymer;
--- Part 2. Orthodontic base polymer.
This part is the first part.
This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY 0270-2003 "dental denture base polymer" and YY 0768-2009 "dental denture base set Compound impact strength test, compared with YY 0270-2003 and YY 0768-2009, the main technical changes are as follows. --- Added 5.2.10 to enhance the maximum stress intensity factor performance requirements of the impact resistant material and the content of the test method; --- Added 5.1.11, the performance requirements of the total fracture work and the content of the test method; --- In this part, replace the YY 0768-2009 "dental denture base" with "8.6, using the improved bending test to measure fracture toughness" Compound impact strength test.
This section uses the translation method equivalent to ISO 20795.1.2008 "Dental Science Base Polymers Part 1. Denture Base Polymerization And ISO 20795.1.2008/Cor.1.2009 "Dental Base Polymers Part 1. Denture Base Polymer Technology Errata 1". This section has made the following editorial changes.
---Delete ISO Preface and ISO Introduction;
--- Remove ISO 1.2, increase 9.3n) the main components of the material and its content. The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows. ---GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD); ---GB/T 7408-2005 Data element and exchange format information exchange date and time representation (ISO 8601.2004, IDT);
---GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)];
---YY 0300-2009 Artificial teeth for dental restoration (ISO 22112.2005, MOD); ---YY/T 0631-2008 Determination of the colour stability of dental materials (ISO 7491.2000, IDT). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Devices (SAC/TC99). This section drafted by. Peking University School of Stomatology Oral Medical Device Testing Center. The main drafters of this section. Lin Hong, Zhang Dianyun, Zheng Rui, He Mingming, Zheng Gang, Xu Yongxiang. The previous versions of the standards replaced by this section are.
---ZBC33020-1988;
---YY 0270-1995, YY 0270-2003;
---YY 0768-2009.
YY 0270.1-2011/ISO 20795-1.2008
introduction
For many years, methacrylate-based polymer materials have been widely used in the manufacture of denture bases in dental restorations. With repair With the development of therapeutic techniques, some performance-enhancing materials, such as impact-resistant materials, have appeared on the market. This standard does not contain qualitative and quantitative requirements for biohazard, but when evaluating possible biological or toxicological hazards, it is recommended Refer to GB/T 16886 and YY/T 0268.
YY 0270.1-2011/ISO 20795-1.2008
Dentistry base polymer
Part 1. Denture base polymer
1 Scope
1.1 This section classifies denture base polymers and copolymers, specifies requirements, and specifies the tests to be used to determine compliance. The method of inspection, and the requirements for the packaging, marking of the product and the instructions for use of the applied materials. This section applies to the system The denture base polymers of the impact-resistant materials of the manufacturer's declaration also specify their respective requirements and test methods. 1.2 Examples of denture base polymers referred to in this section are as follows. a) polyacrylates;
b) polyacrylates containing substituents;
c) polyvinyl esters;
d) polystyrene;
e) rubber modified polymethacrylates;
f) polycarbonates;
g) polysulfones;
h) polydimethacrylates;
i) polyacetal polyoxymethylene;
j) Copolymers or mixtures of the polymers listed in a) to i).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. YY/T 0631-2008 Determination of colour stability of dental materials (ISO 7491.2000, IDT) ISO 463.2006 Product geometry specification (GPS) Design and metrology characteristics of mechanical measuring instruments for dimensional measuring equipment [GeometricalProductSpecifications(GPS)-Dimensionalmeasuringequipment-Designandmetro- Logicalcharacteristicsofmechanicaldialgauges]
ISO 1942 oral vocabulary (Dentistry-Vocabulary)
ISO 3696 Analytical Laboratory Water Specifications and Test Methods (Waterforanalyticallaboratoryuse-Specification) Andtestmethods)
ISO 8601 data element and exchange format information exchange date and time representation (Dataelementsandinterchange formats-Informationinterchange-Representationofdatesandtimes)
ISO 22112.2005 Dentistry-Artificaltefordfordalalprostheses
3 Terms and definitions
The following terms and definitions defined by ISO 1942 apply to this document. 3.1
Self-setting material autopolymerizablematerials
The polymerization is initiated by a chemical method, and the polymerization product can be completed without a temperature of 65 ° C or higher. YY 0270.1-2011/ISO 20795-1.2008
3.2
Capsule-packed material capsulatedmaterial
The container is provided with two or more components separated from each other, and when used, the components of the material are mixed directly from the container Take out and use.
3.3
Denture denture
Artificial substitutes for missing teeth and their adjacent tissues also include accessory parts that make them optimal for function. 3.4
Denture base denturebase
A part of the denture is placed on the soft tissue and the artificial tooth is mounted on it. 3.5
Thermosetting material heat-polymerizablematerials
The temperature needs to be above 65 °C to complete the polymerization product. 3.6
Inner packaging immediatecontainer
A container that is in direct contact with the denture base material.
3.7
Liquid liquid
It can be mixed with polymer particles to form a boxable plastic dough-like or flowing resin matrix monomer liquid for making a denture base. 3.8
Powder powder
It can be mixed with a monomer liquid to form a polymer particle having a plastic dough-like or flowing resin matrix for making a denture base. 3.9
Outer packaging
A container with a label, or a package with other containers inside.
3.10
Packing
(for dentures) (pressure, casting, injection technique) filling the denture base cavity to form the denture base process.
3.11
Initial boxing time initialpackingtime
The denture base material is from the end of the blending or other operation to the time when the material initially reaches the consistency of the package. 3.12
Final boxing time finalpackingtime
After reaching the initial loading time, the denture base material can maintain the final time of packing consistency. 3.13
Processing
The process of preparing a solid denture base and/or sample by polymerization or injection molding. 3.14
Thermoplastic thermoplastic, adj
The hard polymer material can be softened and shaped by heating, and can be restored to a hardened state after cooling. 3.15
Translucent translucency
A material body allows light to pass through, but diffuses the light, rendering the object unable to present a clearly visible state on the other side. YY 0270.1-2011/ISO 20795-1.2008
4 classification
The denture base polymers referred to in this section are classified as follows. ---1 type. thermosetting material;
● Class 1. powder and liquid;
● Class 2. plastic paste;
---2 type. self-setting material;
● Class 1. powder and liquid;
● Class 2. powder and liquid of castable resin;
---3 type. thermoplastic billet or powder;
---4 type. light curing material;
---5 type. microwave curing material.
5 requirements
5.1 Unpolymerized materials
5.1.1 Liquid component
5.1.1.1 General performance
The liquid should consist of a monomer material that matches the powder. 5.1.1.2 Uniformity
Visual observation (8.1.1), there should be no precipitation or impurities in the liquid. 5.1.2 Solid components
Visual inspection (8.1.1), there should be no foreign impurities in the solid and semi-solid components. 5.1.3 Packing plasticity
At the initial packaging time recommended by the manufacturer, the test shall be carried out in accordance with 8.2 for Type 1 Type 1 and Type 2 Class 1 materials, and the material shall be extruded into the mold (8.2.2.1). The number of holes with a depth of not less than 0.5 mm (see 8.2.4.2) shall be at least 2. In the final boxing time (see 8.2.4.3) for type 1 type 1 and type 1 type 2 Testing with Type 5 materials should also meet the above requirements.
5.2 Polymerized materials
5.2.1 Biocompatibility
This section does not contain qualitative and quantitative requirements for biohazard, but when evaluating possible biological or toxicological hazards, it is recommended to According to GB/T 16886.1 and YY/T 0268.
5.2.2 Surface characteristics
5.2.2.1 Dentures prepared in accordance with 8.4.3, 8.8.2.2 and 8.9.3, using the manufacturer's recommended method of processing and contact with materials The base specimen shall have a smooth, smooth hard surface (see 8.1.1). 5.2.2.2 Color stability samples, residual methyl methacrylate monomer samples and samples for water absorption and dissolution tests shall retain their shape after processing. YY 0270.1-2011/ISO 20795-1.2008
Shape and no visible deformation (see 8.1.1).
5.2.2.3 Polished according to 8.5.1.4, the surface of the sample shall be smooth and shiny. 5.2.3 Formability
The test specimens prepared according to the manufacturer's instructions (see 8.5.1.4) for all types of denture base polymers should be clearly removed from the mold. (see 8.5.1.4).
5.2.4 Color
According to the 8.3 test, according to the observation and comparison in 8.1.1, the color of the test strip should be consistent with the manufacturer's statement. Manufacturers should provide color plates.
The colored denture base polymer should be translucent (see 5.2.6 and 8.5.2) and the colorant and/or fiber uniform. (Transparent) colorless denture base polymers should be colorless and transparent. 5.2.5 Color stability
According to the 8.4 test, according to 8.1.1, the color of the sample should only be slightly changed. 5.2.6 Translucency
According to the test of 8.5.2.3, the shadow of the illuminated opaque disc should be visible through the specimen. 5.2.7 No porosity
According to the sample prepared in 8.5.3.3, there should be no porosity by visual observation (see 8.1.1). 5.2.8 Ultimate flexural strength
According to the test of 8.5.3.5, the ultimate flexural strength of type 1, type 3, type 4 and type 5 polymers shall not be less than 65 MPa, and type 2 polymers shall be Not less than 60MPa (see Table 1).
5.2.9 Flexural modulus of elasticity
According to the test of 8.5.3.5, type 1, type 3, type 4 and type 5 polymers, the flexural modulus of the polymer after processing shall not be lower than 2000MPa, type 2 polymer should not be less than 1500MPa (see Table 1).
5.2.10 Maximum stress intensity factor of impact resistant materials
For materials that the manufacturer claims to enhance the impact resistance, according to 8.6 test, the maximum stress intensity factor should be no less than 1.9MPam1/2 (see Table 2).
5.2.11 Total work of fracture
For materials that the manufacturer claims to have impact resistance, the total fracture work should be no less than 900 J/m2 according to 8.6 (see Table 2). 5.2.12 Bonding to synthetic polymer teeth
Denture base polymers for use with synthetic polymer teeth should meet one of the following requirements. a) The denture base polymer shall be capable of bonding to synthetic polymer teeth conforming to ISO 22112 bonding requirements in accordance with 8.7; b) If there is a problem with the bond, the manufacturer's instructions should give information on the special handling of the bond [see 9.3k)]. 5.2.13 Residual methyl methacrylate monomer
Prepare the sample in accordance with 8.8 and test it in accordance with the following regulations (see Table 1). YY 0270.1-2011/ISO 20795-1.2008
The maximum residual methyl methacrylate content of Type 1, Type 3, Type 4 and Type 5 denture base polymers should be 2.2% (mass fraction).
The maximum residual methyl methacrylate monomer content of the Type 2 denture base polymer should be 4.5% (mass fraction). If the manufacturer claims that the residual methyl methacrylate monomer content of the product is lower than the above requirements [see 9.3m)], the residual monomer content The measured value shall not be higher than 0.2% (mass fraction) of the manufacturer's stated value (ie the measured value is not greater than the sum of the manufacturer's stated value and 0.2%). 5.2.14 Water absorption value
The prepared sample shall be tested according to 8.9. The increase in the mass per unit volume of the polymer (water absorption) shall not exceed 32 μg/mm3 (see Table 1).
5.2.15 Dissolution value
The prepared sample was tested according to 8.9, and the mass loss per unit volume of the type 1, type 3, type 4 and type 5 polymers was dissolved. The solution should not exceed 1.6 μg/mm3; the type 2 should not exceed 8.0 μg/mm3 (see Table 1). Table 1 Summary of requirements in 5.2.8, 5.2.9, 5.2.13, 5.1.14 and 5.2.15 Claim
Flexural performance
Extreme scratch
Curve strength σ
MPa
Minimum
Flexural flexibility
Modulus E
MPa
Minimum
Residual methacrylic acid
Methyl ester monomer
Percentage of quality score
maximum
Water absorption value
Wsp
Gg/mm3
maximum
Dissolution value
Wsl
Gg/mm3
maximum
1,3,4,5 type 65.2000 2.2 32 1.6
Type 2 60 1500 4.5 32 8.0
Table 2 Additional requirements for impact resistance materials described in 5.2.10 and 5.21.1 Claim
Fracture toughness
Maximum stress intensity factor Kmax
MPam1/2
Minimum
Total work of fracture Wf
J/m2
Minimum
Impact resistance material 1.9 900
6 sampling
A sufficient amount of material is drawn from one or several retail packages for the specified tests, including the necessary repeated tests allowed. If For several packages, all materials should be the same lot number.
7 sample preparation
7.1 Test environment
Except as otherwise specified in this section or the manufacturer, all samples shall be prepared and tested at (23 ± 2) ° C, relative humidity (50 ± 10) The environment is carried out in %.
YY 0270.1-2011/ISO 20795-1.2008
7.2 Steps
Except as otherwise provided in this section, the materials used in the preparation of the test specimens shall be made using the equipment and methods recommended by the manufacturer's instructions (see 9.3). Preparation, operation and processing.
Samples prepared by blending two or more components are required, and each sample or test strip should be prepared separately. 7.3 Special equipment
Special equipment specified by the manufacturer for material processing shall be provided by the manufacturer. 8 test methods
8.1 Visual inspection
8.1.1 Visual observation
Visual inspection, the sample shall comply with the requirements of 5.1.1.2, 5.1.2, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.6, 5.2.7 and Chapter 9. [Check color (5.2.4) and color stability (5.2.5) according to YY/T 0631]. 8.1.2 Expression of results
Report whether the liquid component meets the requirements (see 5.1.1.2). Report whether the solid components meet the requirements (see 5.1.2).
Report whether the surface of the denture base sample is smooth, hard and shiny (see 5.2.2.1), and whether the sample meets the requirements. Report whether the molded specimen retains its shape, is free of deformation, and the specimen meets the requirements (see 5.2.2.2). Report whether the surface of the polished sample is smooth and shiny, and the test piece meets the requirements (see 5.2.2.3). Report whether the edge of the sample is clear and the test piece meets the requirements (see 5.2.3). Report whether the materials meet the requirements for labels, signs, packaging and instructions for use (see Chapter 9). 8.2 Packing plasticity
8.2.1 Materials
8.2.1.1 Polyethylene or polyester film. thickness is 0.035mm~0.050mm, length and width are about 50mm×50mm. 8.2.1.2 Glass plate. (60 ± 5) mm × (60 ± 5) mm × (5 ± 1) mm.
8.2.2 Appliances
8.2.2.1 Brass mold with holes. The dimensions are shown in Figure 1. The hole diameter should be (0.75 ± 0.05) mm. 8.2.2.2 Counterweight, (50 ± 1) N.
8.2.2.3 Dial indicator, in accordance with ISO 463, or linear gauge with an accuracy of 0.01 mm with probe. The probe can enter the brass mold hole Inside, measure the depth of the material that is forced into the hole. 8.2.3 Test conditions
Unless otherwise stated by the manufacturer, the perforated brass mold (8.2.2.1) and the glass plate (8.2.1.2) shall be placed under the conditions specified in 7.1. 8.2.4 Steps
8.2.4.1 General conditions
After the materials were mixed, the tests were carried out as shown in Table 3. See 3.11 and 3.12 boxing time definitions. YY 0270.1-2011/ISO 20795-1.2008
The unit is mm
Note. The dimensional deviation is ±1mm when not specified.
Figure 1 Perforated brass mold for boxing plastic test
Table 3 Test s...

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