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YY/T 0519-2022: Dentistry - Testing of adhesion to tooth structure
YY/T 0519-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.10
CCS C 33
Replacing YY/T 0519-2009
Dentistry - Testing of adhesion to tooth structure
(ISO/TS 11405:2015, MOD)
ISSUED ON: JULY 01, 2022
IMPLEMENTED ON: JULY 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 Sampling ... 8
5 Test method ... 8
Appendix A (Informative) Test methods for measuring bond strength ... 20
Appendix B (Informative) Tensile bond strength test method ... 22
Appendix C (Informative) Micro-tensile bond strength test method ... 24
Appendix D (Informative) Shear bond strength test method (I) ... 25
Appendix E (Informative) Shear bond strength test method (II) ... 28
Bibliography ... 30
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) ℃ to (37±2) ℃ (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.
5.2.4.3 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.
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.
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) ℃ and stored in water at (37±2) ℃ 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.