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YY/T 0825-2011: Dentistry. Products for external tooth bleaching
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0825-2011 | English | 329 |
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Dentistry. Products for external tooth bleaching
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YY/T 0825-2011
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Standard similar to YY/T 0825-2011 YY 1042 YY/T 0823 YY/T 0824 YY/T 0826 Basic data | Standard ID | YY/T 0825-2011 (YY/T0825-2011) | | Description (Translated English) | Dentistry. Products for external tooth bleaching | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 14,199 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 7408-2005; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5; YY/T 0528-2009; YY/T 0632-2008; GB/T 9258.1 | | 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 outside of the teeth bleaching product requirements and test methods. These products dentist or dental professionals (clinic teeth bleaching products) or through a dentist or dental professionals to guide consumers (professional home teeth bleaching products) used in the oral cavity. This standard also specifies requirements for packaging, labeling and instructions for use requirements. This standard does not apply the following tooth bleaching products: ISO 11609 in the contents specified, by mechanical means (e. g., stain removal) or a repair method using, for example, veneer or crown, etc., to change the color of natural teeth, with bleach with the product the auxiliary or additional materials (such as pallets material) and appliances or devices (such as lights). This standard is not the teeth bleaching products made ??biosafety regulations. | YY/T 0825-2011: Dentistry. Products for external tooth bleaching---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.Products for external tooth bleaching
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
Dentistry tooth bleaching products outside
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
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. Distribution of this document
Institutions do not assume the responsibility to identify 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. Nanchang Yang Pu Technology Co., Ltd.
The main drafters of this standard. Zheng Rui, Lin Hong, Zhang Dianyun, Wangyi Nong, Xu Yongxiang.
Introduction
Outer tooth bleaching products used in dentistry is used to change the color of natural teeth, making it lighter or white products. Such products directly
In the mouth of the outer surface of the tooth. This standard provides for the use of chemical methods outside the natural teeth bleaching product requirements and tests
method.
Evaluation of dental bleaching effect needs further research and data collection, this standard does not provide for the teeth to be bleached effect.
Appendix B of this standard informative appendix, providing the user with an evaluation method for reference.
Dentistry tooth bleaching products outside
1 Scope
This standard specifies the requirements and test methods for their teeth whitening products. These products through the dentist or dental professionals (consultation
In the oral cavity chamber with the teeth bleaching products) or to guide consumers through the dentist or dental professionals (professional home teeth bleaching products)
use. This standard also provides for the packaging, labeling and instructions for use requirements.
This standard does not apply following tooth bleaching products.
--- ISO 11609 as specified in content;
--- By mechanical means (for example, remove stains) or using repair methods, such as veneers or crowns, etc., change the natural color of the teeth;
Auxiliary or additional material (such as tray material) and appliances or devices (such as lights) --- and bleaching products used together.
This standard does not provide for bio-safety tooth bleaching products.
NOTE. to use GB/T 16886.1 and YY/T 0268 evaluation of biological safety tooth bleaching products.
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.
GB/T 7408-2005 data elements and interchange formats - Information interchange the date and time notation
GB/T 9937 (all parts) oral vocabulary
YY/T 0528-2009 Dental metallic materials corrosion test
Determination of YY/T 0632-2008 peroxide tooth bleaching material content
GB/T 9258.1 coated abrasives Analysis Part 1 abrasive particle size. Grain size
3 Terms and Definitions
GB/T 9937 defined by the following terms and definitions apply to this document.
3.1
Bleaching bleaching
By chemical methods or a combination of ancillary remove original or acquired colored stains from natural teeth.
3.2
Professional home use professionalhomeuse
By a dental professional prescription, and under the dentist or dental professional close supervision in the family to use.
Category 4
4.1 Summary
Their teeth whitening products can be divided into two types.
a) professional use;
b) professional and home use.
Note. the outer tooth bleaching products can be used alone or in combination with additional methods.
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