YY/T 0826-2011 English PDF

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YY/T 0826-2011: Dental temporary polymer-based crown and bridge materials
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0826-2011	229	Add to Cart	3 days	Dental temporary polymer-based crown and bridge materials	Valid

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Basic data

Standard ID: YY/T 0826-2011 (YY/T0826-2011)
Description (Translated English): Dental temporary polymer-based crown and bridge materials
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Word Count Estimation: 10,112
Date of Issue: 2011-12-31
Date of Implementation: 2013-06-01
Quoted Standard: GB/T 6682-2008; YY 0710-2009; YY 1042-2011
Regulation (derived from): State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the temporary dental crown and bridge materials, polymer-based classification and requirements, but also with the provisions of these standards require a corresponding test methods. This standard applies to clinical tooth preparation, before a permanent fix for the protection of temporary abutments after preparation of polymer-based crown and bridge materials. This standard does not apply to laboratory-fabricated restorations with a permanent polymer-based crown and bridge materials (see YY 0710-2009), does not apply directly used in dentistry crown, veneer or polymer-based materials and repair those used for posterior teeth bearing area of ??the material (see YY 1042).

YY/T 0826-2011: Dental temporary polymer-based crown and bridge materials

---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.
Dental temporary polymer-based crown and bridge materials ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Polymer-based dental temporary crown and bridge materials Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

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. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee materials and oral appliances and equipment (SAC/TC99) centralized. This standard is mainly drafted by. Peking University School of Stomatology, medical equipment and test center. Units involved in the drafting of this standard. Nisshin Dental Materials (Kunshan) Co., Ltd., 3M China Limited. Drafters of this standard. Shen Xi Wei, Bai Wei, Lin Hong, Yun Xiao Fei, Li Yuan. Polymer-based dental temporary crown and bridge materials

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 temporarypolymer-basedcrownandbridgematerial 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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