YY 0271.1-2016Dentistry—Water-based cements - Part 1: Powder/liquid acid-base cements (English PDF)
牙科学水基水门汀第1部分:粉/液酸碱水门汀
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
July 29, 2016
Implementation date
June 1, 2018
Scope
YY 0271.1-2016 is the English-translated version of 牙科学水基水门汀第1部分:粉/液酸碱水门汀.
YY 0271.1-2016 is the Chinese pharmaceutical industry standard for the powder and liquid acid-base water-based cements used in dentistry for permanent cementation, for bases and linings and for repair.
It is the first part of the YY 0271 series and sets the technical requirements and the test methods for them, covering the setting time and the film thickness, the compressive strength, the acid erosion and the solubility, the opacity and the colour, with the limits fixed separately for each intended use.
It applies to cements mixed by hand and to capsules mixed mechanically, and it does not apply to resin-modified water-based cements. Issued on 29 July 2016, it applies from 1 June 2018.
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Document preview — YY 0271.1-2016
National Standard of the People's Republic of China
- ICS
- 11.060.10
- Classification
- C 33
- Replacing
- YY 0271.1-2009
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- Introduction
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 5 material
- 6 Sample preparation
- 7 sampling
- 8 requirements
- 9 Packaging, identification and information provided by the manufacturer
- Appendix A (informative) Chemical composition and application of dental cements
- Appendix B (normative) Test for net cure time
- Appendix C (normative) Test of film thickness (only for cementing cements)
- Appendix D (normative) Test for compressive strength
- Appendix E (normative appendix) Test of acid etching
- Appendix F (informative) Test of optical properties (optical properties) (only for the repair of polyalkenylate glass cements)
- Appendix G (normative) Test for optical properties (color) (only for polyacrylate glass cements for repair)
- Appendix H (Normative Appendix) Test for Acid Soluble Arsenic Content and Lead Content
- Appendix I (normative appendix) X-ray resistance test Reference
Foreword
The technical content of this standard is mandatory.
YY 0271 "Dental Water-based Water Pavilion" consists of two parts.
- Part 1. powder/liquid acid and alkali;
- Part 2. Resin modified. This part is part 1 of YY 0271.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0271.1-2009 "Dental Water-based Cementing Part 1. Powder/Acid-Base Alkaline".
The main technical changes in this section and YY 0271.1-2009 are as follows.
--- increase the X-ray resistance of the test and requirements;
- the requirements of the manual reconcile the requirements of the requirements of the cement and the cements of the cement factory, --- increase the opacity of the test and requirements;
--- increase the color of the test and requirements;
- arsenic content test method based on the "by the People's Republic of China Pharmacopoeia (2005 edition) in the method" to "in accordance with the ISO 2590 method (Arbitration Act) or by the People's Republic of China Pharmacopoeia (2010 edition) method of testing arsenic content ";
- laboratory analysis of water, from "deionized water or distilled water" to ISO 9917-1.:2007 ISO 3696. 1987, Level 3 water;
--- Added reference.
This part of the modified use of ISO 9917-1.:2007 "dental water-based cement Pavilion Part 1. powder/liquid acid alkali cement." The main differences between this section and ISO 9917-1.:2007.
- delete 8.5a in ISO 9917-1.:2007) and its contents;
- Appendix F is split into Appendix F and Appendix G, Appendix F becomes informative, and the serial numbers of the appendix are extended in sequence;
The test method of arsenic content has increased the content of the method according to the method of the Pharmacopoeia of the People's Republic of China (2010 edition).
In this part of the normative reference to the international documents have a consistent correspondence between the following documents.
Analysis of laboratory water specifications and test methods (ISO 3696. 1987, MOD); GB/T 6682-2008;
Determination of color stability of dental materials (ISO 7491.:2000, IDT) YY/T 0631-2008.
Introduction
This section does not contain qualitative and quantitative requirements for the assessment of biological hazards. When evaluating possible biological or toxicological hazards, Use ISO 7405 and ISO 10993-1.
1 Scope
This part of YY 0271 specifies the technical requirements for permanent cementing, bottoms/lining and repair of dental powder/liquid acid base And test methods. This part of YY 0271 is also suitable for hand-blended water-based cements or mechanically tuned capsules.
This section sets limits for each performance as it is intended for use as a cement, bottom or lining or repair material. Headquarters Points do not apply to resin-modified water-based cement.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
ISO 2590 General method for the determination of arsenic content Diethyldithiocarbamate photometric method (Generalmethodforthe determinationofarsenic-silverdiethyldithiocarbamatephotometricmrthod) A period of time from the time of reconciliation (if required), during which time the engine can be operated and has no adverse effect on its performance.
ISO 3665.:1996 Photography-Intra-oraldentalra-diographicfilm-Specification
ISO 3696 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specification andtestmethods)
ISO 7491 Determination of color stability of dental materials (Dentalmaterials-Determination ofcolourstability)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Reconciliation time
The components meet the part of the time required for adequate mixing.
3.2 Working hours
A period of time from the time of reconciliation (if required), during which time the engine can be operated and has no adverse effect on its performance.
3.3 Net cure time
The time required for the end of the self-tuning time to reach the material in accordance with the parameters and conditions specified in Appendix A.
Note. Based on the purpose of this part of YY 0271, taking into account the different mixing time difference between the different cement, the net curing time is from the end of the reconciliation time Timing.
4 Classification
4.1 Chemical classification
The chemical composition of dental cement and its application is given in Appendix A. For the purposes of this section, dental fittings are based on chemical composition
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 2590 · ISO 3665 · ISO 3696 · ISO 7491
Similar standards
Editions of YY 0271.1
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0271.1-2016 | Dentistry—Water-based cements - Part 1: Powder/liquid acid-base cements | current edition | Current |
| YY 0271.1-2009 | Dentistry—Water-based cements - Part 1: Powder/liquid acid-base cements | previous edition | Superseded |
This page sells the current edition, YY 0271.1-2016. Earlier editions are listed for reference only.
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Related Standards
YY 0271.2-2024 — Dentistry - Water-based cements - Part 2: Resin-modified cements
YY 0271.2-2016 — Dentistry - Water-based cements - Part 2: Resin-modified cements
YY 0271.1-2009 — Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
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