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YY 1042-2023: PDF in English

YY 1042-2023 YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.060.10 CCS C 33 Replacing YY 1042-2011 Dentistry - Polymer-based Restorative Materials 牙科学 聚合物基修复材料 (ISO 4049.2019, MOD) ISSUED ON. NOVEMBER 22, 2023 IMPLEMENTED ON. DECEMBER 1, 2026 Issued by. National Medical Products Administration Table of Contents Foreword... 3 Introduction... 5 1 Scope... 6 2 Normative References... 6 3 Terms and Definitions... 7 4 Classification... 7 4.1 Type... 7 4.2 Class... 8 5 Requirements... 8 5.1 Physical and Chemical Properties... 8 5.2 Shade of Restorative Materials... 10 5.3 Color Stability after Irradiation and Water Absorption... 10 5.4 Radio-opacity... 10 6 Sampling... 11 7 Test Methods... 12 7.1 General Reagent --- Water... 12 7.2 Test Environment... 12 7.3 Inspection... 12 7.4 Specimen Preparation... 12 7.5 Measurement of Film Thickness of Luting Materials... 13 7.6 Working Time of Class I and Class III Restorative Materials (except luting materials) ... 16 7.7 Working Time of Class I and Class III Luting Materials... 19 7.8 Curing Time of Class I and Class III Materials... 19 7.9 Ambient Light Sensitivity of Class II Materials... 21 7.10 Curing depth of Class II Materials (except luting materials)... 22 7.11 Flexural Strength... 24 7.12 Water Absorption Value and Dissolution Value... 28 7.13 Shade and Color Stability after Irradiation and Water Absorption... 32 7.14 Radio-opacity... 34 8 Packaging, Marking, Instructions and Information Provided by the Manufacturer. 34 8.1 Packaging... 34 8.2 Marking and Instructions for Use... 34 8.3 Declaration of Components... 38 Bibliography... 39 Dentistry - Polymer-based Restorative Materials 1 Scope This document specifies the requirements for dental polymer-based restorative materials. This type of material, which is provided in a form suitable for mechanical mixing, manual blending, or intra-oral and extra-oral activation by external energy, is mainly used for direct or indirect restoration and luting of teeth. The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and restorative devices, such as. inlays, onlays, veneers, crowns and bridges. This document does not cover polymer-based luting materials containing adhesive components (see ISO/TS 16506). This document does not cover dental polymer-based materials used to prevent dental caries (see YY 0622), core materials or veneer materials used on metal bases (see YY 0710). 2 Normative References The contents of the following documents constitute indispensable clauses of this document through normative references in the text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 6682-2008 Water for Analytical Laboratory Use - Specification and Test Methods (ISO 3696.1987, MOD) GB/T 9937 Dentistry - Vocabulary (GB/T 9937-2020, ISO 1942.2009, MOD) YY/T 0631 Dental Materials - Determination of Color Stability (YY/T 0631-2008, ISO 7491.2000, IDT) YY/T 1599 Dentistry - Test Method for Polymerization Shrinkage of Polymer-based Restorative Materials - Laser Ranging Method YY/T 1646-2019 Dentistry - Test Method for Determining Radio-opacity of Materials (ISO 13116.2014, IDT) ISO 8601-1.2019 Date and Time - Representations for Information Interchange - Part 1.Basic Rules NOTE. GB/T 7408-2005 Data Elements and Interchange Formats - Information Interchange - Representation of Dates and Times (ISO 8601.2000, IDT) ISO 8601-2.2019 Date and Time - Representations for Information Interchange - Part 2. Type II. other polymer-based restorative materials and luting materials, except Type I. 4.2 Class Dental polymer-based restorative materials are divided into the following three classes. ---Class I. materials that are cured by mixing initiators and accelerators (self-curing materials). ---Class II. materials that are cured by activation by external energy sources, such as. blue light or heating (see Item 9 and Item 20 in Table 4 for “external energy activated” materials). It can be divided into the following two groups. 1) Group 1.materials that require energy activation in the oral cavity. 2) Group 2.materials that require energy activation outside the oral cavity. After curing is completed, the materials are luted into place. The manufacturer may claim that some materials belong to both Group 1 and Group 2. At this time, this type of material shall simultaneously satisfy the requirements of both groups. NOTE. Class II luting materials only belong to Group 1. ---Class III. materials that are cured by external energy and have a self-curing mechanism (dual curing materials). 5 Requirements 5.1 Physical and Chemical Properties 5.1.1 General requirements If the manufacturer provides multiple shades of restorative materials, each shade, including the opaque shade, shall be able to satisfy the various requirements of the materials for ambient light sensitivity (5.1.7) and curing depth (5.1.8), shade (5.2) and color stability (5.3) in the corresponding type and class. If the material provided can be “pigmented” or “mixed” in accordance with the user’s requirements, then, the material shall comply with the requirements when used alone and after being tinted or blended with the colorant in the maximum recommended proportion (see Item 19 in Table 4). The curing depth (5.1.8) of the luting materials does not need to be tested. Unless the manufacturer claims that the material has color stability, luting materials do not need to be tested for color stability (5.3). For the other requirements in 5.1, and 5.4, only a representative shade of the restorative materials shall be tested. The representative shade shall be that of a material classified as “universal” by the manufacturer, or, if in the absence of such classification, then, the shade “A3” of Vita1) color classification shall be taken as the representative shade. However, if the manufacturer claims that other colors have higher radio-opacity (see 5.4 and Item 28 in Table 4), then, this claim shall be tested. Performance requirements are summarized in Table 1, Table 2 and Table 3. 5.1.2 Film thickness of luting materials Carry out the test in accordance with 7.5.The film thickness of the luting materials shall not be 10 m greater than the manufacturer’s claimed value, and in no case shall the film thickness be greater than 50 m (primary requirement). 5.1.3 Working time of Class I and Class III restorative materials (except luting materials) Carry out the test in accordance with 7.6.The working time of working time of Class I and Class III restorative materials (except luting materials) shall be  90 s. 5.1.4 Working time of Class I and Class III luting materials Carry out the test in accordance with 7.7.The materials shall be able to form a thin layer. During the formation of the thin layer, there shall be no perceptible change in its uniformity. 5.1.5 Curing time of Class I materials When carry out the test in accordance with 7.8, the curing time of Class I restorative materials (except luting materials) shall be  5 min. When carrying out the test in accordance with 7.8, the curing time of Class I luting materials shall be  10 min. 5.1.6 Curing time of Class III materials When carrying out the test in accordance with 7.8, the curing time of Class III materials shall be  10 min. 5.1.7 Ambient light sensitivity of Class II materials When carrying out the test in accordance with 7.9, the materials shall maintain physical uniformity. 5.1.8 Curing depth of Class II materials (except luting materials) First requirement. when carrying out the test in accordance with 7.10, among Class II restorative materials (except luting materials), the curing depth of materials indicated by the manufacturer as shading shall be  1 mm, and the curing depth of other restorative materials shall be  1.5 mm. 1) Vita is a trade name of Vita Zahnfabrik, H Rauter GmbH & CoK G, Postfach 1338, D-79704 Bad Saeckingen, Germany. The information is provided only for the convenience of users of this document and does not constitute a clause of this document. batch number, including the sample required for repeated tests if necessary. The sufficient amount is 50 g. 7 Test Methods 7.1 General Reagent --- Water The test water shall comply with Grade-2 water specified in GB/T 6682-2008. 7.2 Test Environment Unless otherwise specified by the manufacturer, all specimen preparation and tests shall be conducted in environment of (23  2) C. At any time, the relative humidity shall be controlled at greater than 30% and less than 70%. If the material is refrigerated, it shall reach (23  2) C before testing. The determination of the working time (see 7.6) and curing time (see 7.8) of Class III materials shall be carried out under conditions without radiation activation. These materials can be activated by both natural and artificial light sources in the environment. In order to control the material from being activated, the test should be conducted in a dark chamber, and any artificial light should be filtered through a yellow filter. 7.3 Inspection Conduct visual inspection to verify the compliance with the stipulations of Chapter 8. 7.4 Specimen Preparation The specimens of Class II and Class III materials shall be prepared in accordance with the external energy source specified or recommended for the material under test in the manufacturer’s instructions for use (see Item 20 in Table 4). In addition, ensure that the external energy source is in a satisfactory working condition (see YY 0055 for guidance). In accordance with the manufacturer’s instructions for use and the test environment specified in 7.2, blend the materials or prepare specimens through other methods. For tests that require the specimen to be completely cured during the tests (7.11 ~ 7.14), it is of great importance to ensure that the specimen taken out from the mold is uniform. When carrying out visual inspection without a magnifying glass, there shall be no cracks, cavities, discontinuities or bubbles in the specimen. Some polymer-based materials, especially certain luting materials, have a chemical affinity for base metals, making it difficult to remove the specimen from the metal mold. Therefore, attention shall be paid to the information provided by the manufacturer (see Item 26 in Table 4) regarding this property. If the manufacturer claims that the material has this property, then, the molds for preparing the specimens shall be made of non-metallic materials, for example, high- 1---polyethylene tube; 2---polyamide block; 3---stainless steel tube; 4---thermocouple cone measuring probe. Figure 3 -- Measuring Instrument for Working Time and Curing Time (see 7.6 and 7.8) The instrument is composed as follows. a high-density polyethylene (or similar material) tube (1) is installed on a polyamide or similar material block (2). A stainless steel tube (3) is inserted into the hole of the polyamide block. A stable thermocouple (4) is installed in the stainless steel tube. Tube (1) has a length of 8 mm, an inner diameter of 4 mm and a wall thickness of 1 mm. The diameter of the connecting part between the polyamide block (2) and the tube (1) is 4 mm, and the height is 2 mm. The combination of the two forms a specimen tank with a height of 2 mm and a diameter of 4 mm. In order to facilitate the removal of the specimen after the test, the top of the thermocouple (4) is made into a cone shape and embedded 1 mm into the bottom of the specimen tank. The tolerance of the above dimensions is  0.1 mm. The thermocouple is wire is made of a material (for example, copper / constantan) with a diameter of (0.20  0.05) mm and can indicate the temperature change during the curing process of the specimen, and the temperature measurement accuracy is 0.1 C. Connect the thermocouple to an instrument that records temperature (for example, a voltmeter or recorder), and this instrument can record temperature to this accuracy. 7.6.1.2 Timer, with an accuracy of 1 s. 7.6.2 Steps In accordance with the manufacturer’s instructions (see Table 4), prepare the test material and start timing from blending. Maintain the specimen tank in an environment of (23  1) C. 30 s after the start of blending, put the blended material into the specimen tank and record the temperature T0 of the material. Maintain the instrument (7.6.1.1) at (23  1) C and continuously record the temperature of the material, until the temperature exceeds the maximum value. Figure 4 shows a typical recording curve. Once the material is placed in the specimen tank, the temperature immediately rises slightly to T1, then, drops, until it stabilizes at T0, then, the temperature starts to rise again. The point, at which, the temperature starts to rise, indicates the start of the curing reaction, that is, the end of the working time. From (T0  0.1) C, draw a horizontal baseline, and the time corresponding to the intersection of the horizontal baseline and the rising section of the curve is the working time tw. The test result is closely related to temperature, and small temperature changes within the allowed temperature range may cause the test result to differ by a few seconds. The time from the start of blending to the start of temperature rise is recorded as working time tw. more results < 90 s, then, the material does not comply with the requirements of 5.1.3. 7.7 Working Time of Class I and Class III Luting Materials 7.7.1 Instruments 7.7.1.1 2 glass slides. 7.7.1.2 Timer, with an accuracy of 1 s. 7.7.2 Steps 60 seconds after the blending is completed, place a spherical material mass of about 30 mg on the first glass slide (7.7.1.1), and immediately place the second glass slide on the material and squeeze it with a shearing action, so that the material forms a thin layer. Visually observe whether the material is physically uniform. NOTE. in this test, if the material has begun to cure, as the thin layer forms, cracks and voids will appear in the specimen. For rapidly curing materials, the increased viscosity may hinder the formation of the thin layer. Repeat the above-mentioned test 2 more times. Use new samples for each test. Record the results of 3 tests. 7.7.3 Result determination Conduct visual observation. If all three specimens can maintain physical uniformity and form a thin layer, then, the material complies with the requirement of 5.1.4. 7.8 Curing Time of Class I and Class III Materials 7.8.1 Instrument for determining the curing time of Class I and Class III restorative materials Thermocouple test equipment, see the provisions of 7.6.1.1. 7.8.2 Instrument for determining the curing time of Class I and Class III luting materials Thermocouple test equipment, see the provisions of 7.6.1.1.Except that the length of tube (1) is modified into 6 mm, so the height of the specimen tank formed is 4 mm, other dimensions are the same as those specified in 7.6.1.1. 7.8.3 Steps Except that the test instrument (7.8.1) is maintained in an environment with a temperature of (37  1) C, the rest are the same as those specified in 7.6.2. Measure the time from the start of blending, until the temperature reaches the maximum value b) If 3 or more measured times exceed the times specified for the corresponding materials in Table 2 or Table 3, then, the material does not with the requirement of 5.1.5 or 5.1.6. c) If only 3 times do not exceed the times specified for the corresponding materials in Table 2 or Table 3, then, re-perform the test. In the second test, if one or more times exceed the times specified for the corresponding materials in Table 2 or Table 3, then, the material does not comply with the requirement of 5.1.5 or 5.1.6. 7.9 Ambient Light Sensitivity of Class II Materials NOTE. the purpose of this test is to determine whether the material remains operable when placed in the mouth and exposed to ambient light and dental operating light. 7.9.1 Instruments 7.9.1.1 Xenon lamp, or equivalent light source, and equipped with ultraviolet filter, with a color temperature of 5,000 K ~ 7,000 K. The ultraviolet filter is made of borosilicate glass, with light transmittance < 1% below 300 nm, and > 90% above 370 nm. With reference to YY/T 1120, the optimal color temperature of the dental operating light is 4,500 K ~ 6,400 K. Xenon lamp spectral emissions may change over time, so periodic inspection or replacement is recommended. 7.9.1.2 Neutral density filter, which does not change the wavelength distribution of xenon lamp. A neutral density filter (ND filter) is a light-reducing filter that reduces the intensity of light emitted from a xenon lamp without significant adjustments to distance and voltage. ND filters were originally intended for cameras and are easily available. 7.9.1.3 2 glass slides / coverslips. 7.9.1.4 Illuminance meter, capable of measuring illumination of (2,900  200) lx, with an accuracy of  100 lx. 7.9.1.5 Height-adjustable workbench. 7.9.1.6 Non-reflective (matte) black cover, which is used to cover the illuminance meter. NOTE. it can prevent the reflected light from the light receiving unit of the illuminance meter from interfering with the observation of the specimen. 7.9.1.7 Timer, with an accuracy of 1 s. 7.9.2 Steps In a dark chamber, place the light receiving unit of the illuminance meter (7.9.1.4) under the xenon lamp (7.9.1.1) with the ultraviolet filter inserted. After turning on the xenon lamp, allow sufficient time for it to reach a stable color temperature. By one of the methods described in a), b) or c) below, adjust the illuminance to (2,900  200) lx, otherwise, any combination of these procedures may be used. a) Adjust the distance between the xenon lamp (7.9.1.1) and the light receiving unit of the illuminance meter (7.9.1.4), then, use the height-adjustable workbench (7.9.1.5) to place the specimen at this unit. b) Reduce the voltage of the xenon light source equipment. c) Use the neutral density filter (7.9.1.2). NOTE. if voltage adjustment is adopted, then, ensure that the color temperature remains within the specified range. Use the non-reflective black cover (7.9.1.6) to cover the light receiving unit of the illuminance meter. Place a material mass of approximately 30 mg on a glass slide (7.9.1.3), then, move it to the top of the light receiving unit of the illuminance meter and expose it under irradiation light for (60  5) s. Remove the glass slide carrying the specimen from the irradiation area and immediately use a second slide to compress the material in a shearing motion, so as to form a thin layer. Visually observe whether the material texture is physically uniform. In this test, if the material has begun to cure, when the thin layer forms, discontinuities and voids will appear in the specimen. Comparing the specimen with an unirradiated specimen is conducive to observation. Then, repeat the above-mentioned test for 2 more times, using a new specimen each time. Record the results of the 3 tests. 7.9.3 Result determination Conduct visual observation. If the material of the 3 specimens can maintain physical uniformity, then, the material complies with the requirement of 5.1.7. 7.10 Curing depth of Class II Materials (except luting materials) 7.10.1 Instruments 7.10.1.1 Stainless steel mold, used to prepare cylindrical specimens with a length of 6 mm and a diameter of 4 mm. If the manufacturer’s claimed curing depth exceeds 3 mm, then, the length of the mold shall be at least 2 mm longer than twice the claimed curing depth. To facilitate the removal of the specimen, a mold release agent that does not interfere with the If the 3 values of the tested opaque restorative material are all  1.0 mm, and the 3 values of all other materials are  1.5 mm, then, it is deemed that this material complies with the primary requirement of 5.1.8. If the 3 values are not 0.5 mm less than the value claimed by the manufacturer, then, the material complies with the second requirement of 5.1.8. 7.11 Flexural Strength 7.11.1 Instruments 7.11.1.1 Mold, which is used to prepare specimens with specifications (25  2) mm  (2.0  0.1) mm  (2.0  0.1) mm, for example, stainless steel mold. Mold release agent (7.10.1.1) may be used. A suitable mold is shown in Figure 6.For the preparation of metal-affinity materials, see Paragraph 4 of 7.4. 7.11.1.2 2 metal plates, each large enough to cover the mold. For Class II and Class III materials, glass slides shall be used during the polymerization process. 7.11.1.3 Small screw clamp, capable of applying pressure to the metal plate during specimen preparation. Errors generated during the specimen preparation process have a greater impact on the results of this test. For example, when preparing specimens of high-viscosity materials that are difficult to fill, it is easier to mix air bubbles or cause discontinuities in the specimen. If it is difficult to prepare satisfactory specimens from this type of material, then, it is recommended to use an instrument capable of applying a pressure load of 1,000 kg to the metal plate instead of the small screw clamp. 7.11.1.4 Thin film, which can transmit irradiated light and has a thickness of (50  30) m, for example, polyester. 7.11.1.5 White filter paper. 7.11.1.6 Water bath, which can maintain the temperature at (37  1) C. 7.11.1.7 External energy source (used for Class II and Class III materials), the energy source recommended by the manufacturer for the material under test (see Item 20 in Table 4). 7.11.1.8 Micrometer, with an accuracy of at least 0.005 mm. than the limits in Table 1, then, the material does not comply with the requirement of 5.1.9. 7.12 Water Absorption Value and Dissolution Value 7.12.1 Instruments 7.12.1.1 The inner diameter of the mold is (15.0  0.1) mm in diameter and (1.0  0.1) mm in depth, which is used to prepare specimen discs. Split ring molds or “gasket” molds are suitable. For the preparation of materials with affinity for metals, see Paragraph 4 of 7.4. In order to facilitate the removal of the specimen from the mold, a mold release gent that does not interfere with the curing reaction may be used, for example, a hexane solution containing 3% polyvinyl ether wax. 7.12.1.2 Thin film, which can transmit irradiated light, for example, polyester with a thickness of (50  30) m. 7.12.1.3 2 metal plates, large enough to cover the mold. For Class II and Class III materials, use glass sides during the polymerization process. 7.12.1.4 2 desiccators filled with freshly dried silica gel in accordance with the silica gel manufacturer’s instructions. After each constant weight (after each weighing sequence), use re- dried silica gel to replace the original silica gel. 7.12.1.5 External energy source (used for Class II and Class III materials), the energy source recommended by the manufacturer for the material under test (see Item 20 in Table 4). 7.12.1.6 Thermostatic box, the temperature can be maintained at (37  2) C. 7.12.1.7 Analytical balance, with an accuracy of 0.05 mg, satisfying the required measuring range of the test. 7.12.1.8 Micrometer, with an accuracy of at least 0.005 mm. 7.12.1.9 Mold clamp. 7.12.1.10 Plastic tweezers. In order to avoid contaminating the specimen, tweezers shall be used to pick up the specimen throughout the test. 7.12.1.11 Manual dust removal balloon or oil-free air compressor with a nozzle. 7.12.1.12 Timer, with an accuracy of 1 s. 7.12.2 Specimen preparation ......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.