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YY/T 0519-2022Dentistry—Testing of adhesion to tooth structure (English PDF)

牙科学 与牙齿结构粘接的测试

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 1, 2022

Implementation date

July 1, 2023

Scope

YY/T 0519-2022 is the English-translated version of 牙科学 与牙齿结构粘接的测试.

YY/T 0519-2022 is the Chinese pharmaceutical industry standard for testing the adhesion of dental materials to tooth structure.

It describes two methods for measuring bond strength, in tension and in shear, a method for measuring the gap at the margin of a filling, a method for microleakage and further specific bond strength methods, and it guides the selection, storage and handling of the enamel and dentine substrates on which such tests are run, since the substrate governs the result as much as the adhesive does.

It is used by manufacturers of adhesives and restorative materials and by the laboratories that compare them. It replaces YY/T 0519-2009, was issued on 1 July 2022 and has applied since 1 July 2023.

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Document preview — YY/T 0519-2022

National Standard of the People's Republic of China

Replacing
YY/T 0519-2009

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword3
  • Introduction5
  • 1 Scope6
  • 2 Normative references6
  • 3 Terms and definitions6
  • 4 Sampling8
  • 5 Test method8
  • Appendix A (Informative) Test methods for measuring bond strength20
  • Appendix B (Informative) Tensile bond strength test method22
  • Appendix C (Informative) Micro-tensile bond strength test method24
  • Appendix D (Informative) Shear bond strength test method (I)25
  • Appendix E (Informative) Shear bond strength test method (II)28
  • Bibliography30

Foreword

This document was drafted in accordance with the rules given in GB/T 1.1-2020, Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents.

This document replaces YY/T 0519-2009 Dental materials - Testing of adhesion to tooth structure. Compared with YY/T 0519-2009, in addition to structural adjustments and editorial changes, the main technical changes are as follows:

-- Add description of testing between different laboratories (see 5.2.1);

-- Change 0.5% chloramine trihydrate T to 1.0% chloramine trihydrate T (see 5.2.2.4; 5.2.2.4 of the 2009 edition);

-- Change relative humidity (50±5) % to relative humidity (50±10) % (see 5.2.2.6; 5.2.2.6 of the 2009 edition);

-- Change (23±2) °C to (37±2) °C (see 5.4.5; 5.4.5 of the 2009 edition);

-- Add shear bond strength test method (II) (see Appendix E).

This document uses the redrafting method to modify and adopt ISO/TS 11405:2015 Dentistry - Testing of adhesion to tooth structure.

The technical differences between this document and ISO/TS 11405:2015 and their reasons are as follows:

-- Regarding the normative references, this document makes adjustments with technical differences to adapt to our country's technical conditions. The specific adjustments are as follows:

- Use GB/T 6682 which modifies and adopts the international standard to replace ISO 3696;

- Use GB/T 9258.1 which is identical to the international standard to replace ISO 6344;

- Use GB/T 9937 which modifies and adopts the international standard to replace ISO 1942;

- Use YY 0302.1 which modifies and adopts the international standard to replace ISO 3823-1;

- Remove ISO 14155.

-- In 5.2.1, add "... For shear tests, the load can be applied to a clearly defined area and position of the sample, ensuring that the sample is in the correct Dentistry - Testing of adhesion to tooth structure

1 Scope

This document describes two types of test methods for measuring bond strength (tensile and shear), a test method for measuring edge gaps around fillers, a test method for microleakage and some specific test methods for measuring bond strength.

This document is intended to guide the selection, storage and handling of substrates and gives various test methods for testing the quality of the adhesion between oral restorative materials and tooth structure (i.e., enamel and dentin).

This document does not apply to requirements for bonding materials and their properties.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 6682-2008, Water for analytical laboratory use - Specification and test methods (ISO 3696:1987, MOD)

GB/T 9258.1-2000, Coated abrasives - Grain size analysis - Part 1: Grain size distribution test (idt ISO 6344-1:1998)

GB/T 9937, Dentistry - Vocabulary (GB/T 9937-2020, ISO 1942:2008, MOD)

YY 0302.1-2010, Dental rotary instruments - Burs - Part 1: Steel and carbide burs (ISO 3823-1:1997, MOD)

3 Terms and definitions

For the purpose of this document, the following terms and definitions, as well as those given in GB/T 9937, apply.

3.1 Adhere

To form the state of adherence.

The test apparatus shall ensure alignment between the substrate and the bonding material, i.e., the applied tensile force shall be at an angle of 90° (perpendicular) to the ground adherend surface. The connection between the test apparatus and the crosshead of the universal testing machine can be made by a universal joint, chain or rope.

5 Test method

5.2.4.4 Bonding materials that can form films/thin layers and preformed columnar bonded materials When a preformed column is used as the bonding material, paste a piece of adhesive tape that does not react with the adhesive on the surface of the ground test tooth, and the tape shall have a hole with the same size as the contact area of the preformed column.

5.2.4.3 Bonding materials and/or paste-like bonded materials

If the adhesive is to be used together with the bonded material in film form and paste form, or if the bonding material in paste form is used by itself, it is very important to limit the bonding area. This can be accomplished by a material fixture, which has sharp edges that contact the tooth surface and can stabilize the bonding material on the tooth surface prior to curing. For light-curing bonding or bonded materials, the fixture shall provide an adequate passage for the curing light (i.e., the fixture is made of partially or fully light-transmissive material).

When the material fixture can be used multiple times, it is necessary to apply release agents on its inner surface, avoiding applying it on the edge of the fixture. Place the fixture firmly on the tooth in the correct position and fill the fixture slightly overfilled with bonding or bonded materials. Ensure that the material fixture is properly aligned and in contact with the tooth surface during the material curing process. The placement of the material fixture shall be completed within the working time of the bonding material specified by the manufacturer.

If the manufacturer specifies a composite resin for use with an adhesive, all tests shall be performed using that composite resin.

Apply a thin layer of bonding material on the tooth surface in the hole on the tape, and put the bonded column into the hole to contact with the bonding material in the hole.

Accurately fix the position of the column, and after alignment, apply a 10 N pressure to the top of the column for 10 seconds. The entire process from application of the material to fixing of the column shall be completed within the working time specified by the manufacturer. Remove the tape after curing without applying any undesirable stress on the bonded sample. See also 5.2.5.3.2.

5.2.4.5 Storage of samples

The samples shall be prepared at (23±2) °C and stored in water at (37±2) °C before testing. Under normal circumstances, storage in water for 24 hours is sufficient to determine whether the material is moisture-resistant. In accelerated aging tests, hot and cold cycles between 5 °C and 55 °C can be used. Long term storage in water demonstrates the durability of the adhesion.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.

Referenced standards

Editions of YY/T 0519

EditionTitleRevisionStatus
YY/T 0519-2022Dentistry—Testing of adhesion to tooth structurecurrent editionCurrent
YY/T 0519-2009Dentistry—Testing of adhesion to tooth structureprevious editionSuperseded

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