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Basic data | Standard ID | YY 0710-2025 (YY0710-2025) | | Description (Translated English) | (Dentistry - Polymer-based crown and veneer materials) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2028-07-01 | | Older Standard (superseded by this standard) | YY 0710-2009 | | Issuing agency(ies) | National Medical Products Administration | YY 0710-2009: Dentistry. 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.
Dentistry.Polymer-based crown and bridge materials
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
Dentistry - Polymer-based crown and bridge materials
(ISO 10477.2004, MOD)
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
All the technical contents of this standard is mandatory.
This revised standard adopts ISO 10477.2004 "Dentistry polymer based crown and bridge materials."
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 is based on ISO 10477.2004 redrafted, and ISO 10477.2004 technical differences have been incorporated into the text, and they
Covered by the terms of the margin identified by a single vertical line.
The main differences between the standard and the international standard and the reasons are as follows.
ISO 1562 and ISO 8891 --- Normative references ISO 22674 has been replaced by this standard, the ISO 1562 and
Delete ISO 8891, an increase of ISO 22674 standard;
--- Normative references in ISO 3696. 1987 to modify the use of the standard of standard GB/T 6682-2008 "points
Analysis of laboratory water specifications and test methods ";
--- 7.7 bond strength, increased 7.7.2 and 7.7.2.1 ~ 7.7.2.5 Tier 2 content, while increasing the 5, to the original method
7.7.1 Method 1, the remaining provisions of resolution successively postponed;
--- References in the corresponding part of the international standards to national standards.
This standard was proposed by the State Food and Drug Administration.
This standard by the National Standardization Technical Committee of Dental Materials and Devices and equipment.
This standard is drafted by. State Food and Drug Administration, Peking University Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Lin Hong, Sun Zhihui, Li Yuan, Cheng Gang, Zheng Rui, Zhang Yan.
Dentistry - Polymer-based crown and bridge materials
1 Scope
This standard specifies the polymer-based crown and bridge materials classification and requirements, but also provides the appropriate test methods and standards requirements.
This standard applies to crown and bridge material in a polymeric matrix laboratory production and metal surface or out of contact before a permanent crown or veneer.
This standard also applies to manufacturers claimed that without the aid of a metal retaining projection or grid on the base material to the metal base material bonding
Polymer-based crown and bridge materials.
This standard does not apply to direct dental restoration used in crowns, veneers or repair of polymer-based materials, does not apply to those used in posterior teeth
Material bearing area.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 4340.1-1999 Vickers hardness test - Part 1. Test method (eqv ISO 6507-1.1997)
GB/T 6682-2008 analytical laboratory use specifications and test methods (ISO 3696. 1987, MOD)
GB/T 7408-2005 data elements and interchange formats - Information interchange dates and times (ISO 8601.2000, IDT)
GB/T 9258.1-2000 coated abrasive grit size analysis - Part 1. Grain size (idt ISO 6344-1.1998)
YY/T 0631-2008 Determination of color stability of dental materials (ISO 7491.2000, IDT)
ISO 22674 Dentistry fixed and repairing metal material
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
From a monomer, an inorganic filler and/or polymer powder and filler in a liquid or pasty ingredients. Suitable for making permanent veneers or crowns before the polymerization.
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].
3.2
Polymer-based crown and bridge material is colored and slightly translucent, used to simulate the appearance of natural dentin.
3.3
Covering the dentine, the enamel simulate natural appearance of translucent, light colored polymer-based crown and bridge materials.
3.4
Darker colored and slightly translucent polymer based crown and bridge materials, its color to simulate the appearance of natural tooth dentin neck.
3.5
For covering the metal beneath the darker colored polymer-based crown and bridge materials.
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