YY/T 0826-2011Dental temporary polymer-based crown and bridge materials (English PDF)
牙科临时聚合物基冠桥材料
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 0826-2011 is the English-translated version of 牙科临时聚合物基冠桥材料.
YY/T 0826-2011 is the Chinese pharmaceutical industry standard for the polymer-based materials used to make temporary dental crowns and bridges.
It classifies these materials and sets the requirements for them together with the test methods that suit each requirement, covering the setting behaviour and the working time, the flexural strength, the water sorption and solubility, the colour stability, the dimensional accuracy and the information supplied with the material. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY/T 0826-2011
National Standard of the People's Republic of China
- ICS
- 11.060.10
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
This standard does not include the possible biological hazards qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards when, see Khao YY/T 0268 "Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing." This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the temporary dental crown and bridge materials, polymer-based classification and requirements, but also provides them with the appropriate test standard requirements Test methods.
This standard applies to clinical tooth after preparation, pre permanent repair for protection after preliminary temporary abutments with polymer-based crown and bridge materials.
This standard does not apply to laboratory making prostheses with permanent polymer-based crown and bridge materials (see YY 0710-2009), does not apply to Direct dental restoration used in crowns, veneers or repair of polymer-based materials, and those materials in posterior bearing region (see YY 1042).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. Laboratory use specifications and test methods GB/T 6682-2008 Analysis
YY 0710-2009 dentistry polymer based crown and bridge materials
YY 1042-2011 dentistry polymer-based repair materials
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Polymer-based temporary crown and bridge material
From a monomer, an inorganic filler and/or polymer filler powder or paste and liquid ingredients, suitable for making temporary veneers or fronts after polymerization When the crown; or a polymer based bulk materials, the need for clinical use machining molding for temps or temporary crown.
NOTE: polymerization by adding an initiator and catalyst (self-curing materials) and/or by external energy activated [by heat (thermosetting materials), the visible Light (light-curable materials) and/or ultraviolet light activated].
Category 4 This standard is referred to in the provisional classification of the polymer-based crown and bridge materials are as follows.
--- I type. the need for crown and bridge material molded polymeric clinical use;
--- II type. the need for crown and bridge material machining shaping clinical use.
The standard system will be activated by the polymerization I type polymer-based temporary crown and bridge material is divided into the following types.
--- Category 1. Polymer-based crown and bridge materials by mixing the initiator and catalyst cured (self-curable material);
--- Class 2. Polymer-based crown and bridge materials by external activation energy curable (external energy activated materials), such as heating and/or visible Or ultraviolet light;
--- Group 1. initiator polymer-based crown and bridge materials free of visible or UV-sensitive;
--- Two groups. initiator polymer based crown and bridge materials containing visible or UV-sensitive;
--- Three categories. initiator and catalyst, and initiator polymer based crown and bridge materials polymerization (dual cure material) by an external energy.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
YY 0710-2009 — Dentistry - Polymer-based crown and bridge materials
YY 1042-2011 — Dentistry—Polymer-based restorative materials
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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