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YY 0271.2-2024: Dentistry - Water-based cements - Part 2: Resin-modified cements
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Dentistry - Water-based cements - Part 2: Resin-modified cements
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Dentistry - Water-based cements - Part 2: Resin-modified cements
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Basic data | Standard ID | YY 0271.2-2024 (YY0271.2-2024) | | Description (Translated English) | Dentistry - Water-based cements - Part 2: Resin-modified cements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 26,220 | | Date of Issue | 2024-09-29 | | Date of Implementation | 2027-10-15 | | Older Standard (superseded by this standard) | YY 0271.2-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements for resin-modified cements used for bonding, padding or lining, repair and tooth post and core production, and specifies the corresponding test methods. This standard is applicable to resin-modified water-based cements that are cured by a combination of multiple reactions (including acid-base reactions and polymerization reactions). For example, traditional polyalkenoate glass ionomer cements are usually generated by the reaction of ion-releasing aluminosilicate glass and polyalkenoic acid in a water environment. The cements covered by this standard can usually be cured by water-based acid-base reactions, and can also be cured by polymerization reactions. | YY 0271.2-2024: Dentistry - Water-based cements - Part 2: Resin-modified cements---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.060.10
CCSC33
Pharmaceutical Industry Standards of the People's Republic of China
YY 0271.2-2024/ISO 9917-2.2017
Replaces YY 0271.2-2016
Dental water-based cement
Part 2.Resin modified cements
Part 2.Resin-modified cements
(ISO 9917-2.2017, IDT)
Released on 2024-09-29
Implementation on October 15, 2027
The State Drug Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and application 2
4.1 Classification 2
4.2 Application 2
5 Requirement 2
5.1 Materials 2
5.2 Working hours 2
5.3 Curing time - only applicable to Class 1 and Class 3 cements
5.4 Film thickness - only applicable to cementitious cement 3
5.5 Flexural strength 3
5.6 X-ray opacity 3
5.7 Color and color stability---Applicable only to repair cement 3
6 Sampling 3
7 Test conditions and sample preparation 3
7.1 Test conditions 3
7.2 Blending Method 4
7.3 Appearance requirements 4
8 Packaging, labelling and information provided by the manufacturer 4
8.1 Packaging 4
8.2 Labeling and Instructions for Use 4
Appendix A (Normative) Tests for working time and curing time 7
Appendix B (normative) Film thickness test --- only applicable to cementing cement 9
Appendix C (normative) Flexural strength test 11
Appendix D (Normative) X-ray radiopacity test 15
Appendix E (normative) Tests for color and color stability - only applicable to restoration (except for tooth post and core materials) and cementation
Cement 17
Reference 18
YY 0271.2-2024/ISO 9917-2.2017
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is part 2 of YY 0271 Water-based cements in dentistry. YY 0271 has been published in the following parts.
--- Part 2.Resin modified cements.
This document replaces YY 0271.2-2016 "Water-based cements in dentistry Part 2.Resin-modified cements" and
Compared with YY 0271.2-2016, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Tooth post and core fabrication was added to the “Scope” (see Chapter 1);
--- Added tooth post and core production in “Application” (see 4.2);
--- Added "Note" for gelation explanation in "Materials" (see 5.1);
--- Changed the requirements for "film thickness" (see 5.4, 5.4 of the.2016 edition);
--- Changed the requirements for “X-ray radiopacity” and referenced YY/T 1646-2019 (see 5.6, 5.6 of the.2016 edition).
This document is equivalent to ISO 9917-2.2017 "Water-based cements in dentistry - Part 2.Resin-modified cements".
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Instruments (SAC/TC99).
The previous versions of this document and the documents it replaces are as follows.
---First issued in.2009 as YY 0271.2-2009, first revised in.2016, and this is the second revision.
YY 0271.2-2024/ISO 9917-2.2017
Introduction
YY 0271 "Water-based cement in dentistry" is intended to consist of two parts.
--- Part 1.Powder/liquid acid-base cements;
--- Part 2.Resin modified cements.
The curing of resin-modified cement is accomplished by acid-base reaction and polymerization reaction.
It is activated by mixing the components or by external energy.
This document does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended to refer to
GB/T 16886.1 and YY/T 0268.
YY 0271.2-2024/ISO 9917-2.2017
Dental water-based cement
Part 2.Resin modified cements
1 Scope
This document specifies the requirements for resin-modified cements used for cementation, underlayment or lining, restoration and post and core fabrication of teeth.
This document is applicable to resin-modified water-based...
Door tinge.
For example, traditional polyalkenoate glass ionomer cements are usually made of ion-releasing aluminosilicate glass and polyalkenoic acid in water.
The cements covered in this document are usually cured by water-based acid-base reactions and can also be cured by polymerization reactions.
Curing.
Note. Manufacturers and inspection agencies should pay attention to the closely related international standards ISO 4049 (YY 1042-2023/ISO 4049.2019, MOD) and ISO 9917-1
(YY 0271.1-2016/ISO 9917-1.2007, MOD). The most appropriate of the above standards should be considered when evaluating any particular product.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 6682 Specifications and test methods for water used in analytical laboratories (GB/T 6682-2008, ISO 3696.1987, MOD)
GB/T 9258.1 Abrasive particle size analysis for coated abrasives Part 1.Particle size composition (GB/T 9258.1-2000,
ISO 6344-1.1998, IDT)
GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942.2009, MOD)
YY/T 0631 Determination of color stability of dental materials (YY/T 0631-2008, ISO 7491.2000, IDT)
YY 0271.1-2016 Water-based cements for dentistry Part 1.Powder/liquid acid-base cements (ISO 9917-1.2007, MOD)
YY/T 1646-2019 Test method for X-ray radiopacity of materials in dentistry (ISO 13116.2014, IDT)
ISO 8601 (all parts) Data elements and interchange formats - Information interchange - Representation of dates and times
Note. GB/T 7408 (all parts) Date and time information interchange representation [ISO 8601 (all parts)]
3 Terms and definitions
The terms and definitions defined in GB/T 9937 and the following apply to this document.
3.1
Mixing time
The working time required for the components to be thoroughly mixed.
NOTE. Cement within the scope of this document includes single component cements that require mixing and those that do not require mixing.
[Source. YY 0271.1-2016, 3.1, modified]
YY 0271.2-2024/ISO 9917-2.2017
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