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Dentistry. Brazing materials
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YY/T 0912-2015
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Basic data | Standard ID | YY/T 0912-2015 (YY/T0912-2015) | | Description (Translated English) | Dentistry. Brazing materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 10,110 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Quoted Standard | YY/T 0528-2009; ISO 1942; ISO 6344-1; ISO 7405; ISO 10993-1 | | Adopted Standard | ISO 9333-2006, IDT | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies performance requirements and test methods for the preparation of metal prostheses brazing material. |
YY/T 0912-2015: Dentistry. Brazing 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 brazing material)
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
Dentistry brazing material
(ISO 9333.2006, IDT)
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard uses the translation method identical with ISO 9333.2006 "Dentistry brazing material."
Correspondence between the consistency of the standards of international documents and normative references of the following documents.
--- GB/T 9258.1-2000 Coated abrasives - Grain size analysis - Part 1. Grain size (idtISO 6344-1.
1998)
--- GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)]
--- GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
(ISO 10993-1.2009, IDT)
--- YY/T 0268-2008 Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing (ISO 7405.
2008, NEQ)
--- YY/T 0528-2009 Dental metallic materials corrosion test methods (ISO 10271.2001, IDT)
Please note that some of the content of this standard may involve patents. The standard release mechanism should not bear the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the National Standardization Technical Committee materials and oral appliances and equipment (SAC/TC99) centralized.
Drafting of this standard. National Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Zheng Gang, Li Yuan, Yuan Shen slope, Sun Zhihui.
Dentistry brazing material
1 Scope
This standard specifies performance requirements and test methods for the preparation of metal prostheses brazing material.
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.
YY/T 0528-2009 Dental metallic materials corrosion test methods (ISO 10271.2001, IDT)
ISO 1942 oral vocabulary (Dentistry-Vocabulary)
ISO 6344-1 coated abrasive grit size analysis - Part 1. Grain size (Coatedabrasives-Grainsize
analysis-Part 1. Grainsizedistributiontest)
ISO 7405 Dental Oral Biological evaluation of medical devices Science Unit 1. Evaluation and testing (Dentistry-Preclinical
evaluationofbiocompatibilityofmedicaldevicesusedindentistry-Testmethodsfordentalmaterials)
ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing (Biologicalevaluationofmedical
devices-Part 1. Evaluationandtesting)
3 Terms and Definitions
As defined in ISO 1942 and the following terms and definitions apply to this document.
3.1
Brazing material brazingmaterial
In the process of dental alloys connected by brazing to form a dental prosthesis and prosthetic devices filled alloy material.
3.2
Precious metals noblemetal
Gold, platinum, palladium, ruthenium, iridium, osmium, and rhodium.
3.3
Base metal basemetal
All metal elements except precious metals and silver.
4 Requirements
4.1 Chemical composition
4.1.1 Marked components
The manufacturer shall declare all the content is more than 1.0% (mass fraction) of components and should be identified in accordance with 8c) regulations, accurate to 0.1% (mass
Volume fraction). The content of greater than 0.1% (mass fraction), but the composition is less than 1.0% (mass fraction), the manufacturer shall 8c) provisions
Marked its name or element symbol.
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