YY 0271.2-2016 English PDF (YY0271.2-2016)

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YY 0271.2-2016: Dentistry - Water-based cements - Part 2: Resin-modified cements
YY 0271.2-2016
Dentistry - Water-based cements - Part 2. Resin-modified cements
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
YY 0271.2-2016/ISO 9917-2.2010
Replacing YY 0271.2-2009
Dentistry water-based cement
Part 2. Resin modified cement
Part 2. Resin-modifiedcements
(ISO 9917-2.2010, IDT)
Released on.2016-07-29
2018-06-01 implementation
State Food and Drug Administration issued
Content
Foreword III
Introduction V
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and application 2
4.1 Classification 2
4.2 Application 2
5 Requirements 2
5.1 Material 2
5.2 Working hours 2
5.3 Curing time - only for Class 1 and Class 3 cement 2
5.4 Film thickness - only for cemented cement (see 4.2) 2
5.5 Flexural strength 2
5.6 X-ray resistance 2
5.7 Color and color stability - only for repairing cement 3
6 sampling 3
7 Test conditions and sample preparation 3
7.1 Test conditions 3
7.2 Harmonic method 3
7.3 Appearance requirements 3
8 Packaging, labeling and information provided by the manufacturer 4
8.1 Packing 4
8.2 Identification and instruction manual 4
Appendix A (Normative) Test of working time and curing time 6
Appendix B (Normative) Film thickness test - only for cemented cement 8
Appendix C (Normative) Test for Flexural Strength 10
Appendix D (Normative) X-ray resistance test 14
Appendix E (Normative) Test for color and color stability - only for repair and cementing 17
Reference 18
YY 0271.2-2016/ISO 9917-2.2010
Foreword
The full technical content of this standard is mandatory.
YY 0271 "Dental Science Water-based Cement" is divided into two parts.
--- Part 1. Powder/liquid acid and alkali cement;
--- Part 2. Resin modified cement.
This part is the second part of YY 0271.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0271.2-2009 "Dental Water-Based Cement Part 2. Photocuring Cement".
Compared with YY 0271.2-2009, the main changes in this section are as follows.
---The standard name was changed from "Dental Water-Based Cement Part 2. Light-Cured Cement" to "Dental Science Water-Based Cement" No. 2
Part. Resin modified cements;
--- Added standard introduction;
--- Changed Chapter 1 "Scope";
--- Changed Chapter 2 "Regulatory References";
--- Added the terminology of the term "terms and definitions" in Chapter 3, changed the definition of "cure time", and deleted the "initial hardening time"
definition;
--- Changed Chapter 4 "Classification";
--- Increased the requirements and test methods for 5.2 "working hours";
--- Added 5.4 "film thickness" requirements and test methods;
--- Added Table 1 "Dental Cement Requirements";
--- Added Table 2 "Requirements for Identification and Instruction Manual";
--- Appendix C added the test of flexural strength Figure C.2, exemplifying another mold for preparing flexural strength specimens;
--- Appendix digital DX radiation resistance test has been added to the digital device method;
--- Removed the "initial hardening time" requirements and test methods;
--- Removed the "cure depth" requirements and test methods;
--- Removed the requirements and test methods for "opacity".
This section is equivalent to ISO 9917-2.2010 "dental science water-based cement part 2. resin modified cement".
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
---GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD);
---GB/T 7408-2005 Data element and exchange format information exchange date and time representation (ISO 8601.2000,
IDT);
---GB/T 9937 (all parts) Oral vocabulary (all parts) (ISO 1942, IDT);
---YY/T 0631-2008 Determination of colour stability of dental materials (ISO 7491.2000, IDT).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Devices (SAC/TC99).
This section drafted by. State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center, Minnesota Mining Manufacturing
YY 0271.2-2016/ISO 9917-2.2010
(Shanghai) International Trade Co., Ltd., Rijin Dental Materials (Kunshan) Co., Ltd.
The main drafters of this section. Li Yuan, Yuan Shenpo, Zhang Xiaohui, Xu Zhengguo, Zhang Dianyun, Min Min, Shen Xizhen, Lin Hong, Zheng Gang.
The previous versions of the standards replaced by this section are.
---YY 0271.2-2009.
YY 0271.2-2016/ISO 9917-2.2010
introduction
This part of YY 0271 specifies the requirements and test methods for resin modified cements. The curing of these cements is caused by acid-base reaction
It is completed together with the polymerization reaction. The polymer-based component of the reaction can be activated by mixing different components or by external energy.
The test method used in this part of the YY 0271 standard should be as close as possible to ISO 4049 (YY 1042-2011/ISO 4049.2009, MOD)
Consistent with the ISO 9917-1 (YY 0271.1-2016/ISO 9917-1, IDT) standard.
This section of YY 0271 does not contain qualitative and quantitative requirements for product biological hazards, but is recommended for assessing possible biological risks.
When it is harmful, please refer to GB/T 16886.1 "Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management" and
YY/T 0268 "Evaluation and Test of Unit 1 of Biological Evaluation of Dental Medical Devices for Dentistry".
YY 0271.2-2016/ISO 9917-2.2010
Dentistry water-based cement
Part 2. Resin modified cement
1 Scope
This part of YY 0271 specifies the requirements and test methods for dental resin modified cements for cementing, underlaying or lining and repair.
law. These cements are water-based materials that cure by multiple reactions including acid-base reactions and polymerization reactions.
For example, traditional polyalkate glass ionomer cements are usually made up of ion-dissolving aluminosilicate glass and polyalkenoic acid in water.
The reaction is generated in the environment. The cements referred to in this part of YY 0271 are usually capable of curing by this water-based acid-base reaction, but in addition
It can also be cured by polymerization.
Note. Manufacturers and inspection agencies should pay close attention to the closely related international standards ISO 4049 (YY 1042-2011/ISO 4049.2009, MOD) and ISO 9917-1
(YY 0271.1-2016/ISO 9917-1, IDT). The most appropriate international standards mentioned above should be considered when evaluating any particular product.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
ISO 1942 (all parts) Oral vocabulary (Dentistry-Vocabulary)
ISO 3665.1996 Technical specification for dental radiographic film in photography (Photography-Intra-oraldentalra-
diographicfilm-Specification)
ISO 3696 Analytical Laboratory Water Specifications and Test Methods (Waterforanalyticallaboratoryuse-Specification)
Andtestmethods)
ISO 7491 De...