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US$594.00 · In stock Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0270.2-2011: Dentistry. Base polymers. Part 2: Orthodontic base polymers Status: Valid
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Dentistry. Base polymers. Part 2: Orthodontic base polymers
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YY/T 0270.2-2011
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Basic data | Standard ID | YY/T 0270.2-2011 (YY/T0270.2-2011) | | Description (Translated English) | Dentistry. Base polymers. Part 2: Orthodontic base polymers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 30,331 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | YY 0270.1-2011; ISO 1942; ISO 3696; ISO 7491; ISO 8601 | | Adopted Standard | ISO 20795-2-2010, IDT | | 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 applies to the production of active/passive orthodontic appliances orthodontic denture base polymers and copolymers, and provides for its requirements. Also provides for determining compliance with these requirements for test methods. Meanwhile, the accompanying material provides product packaging, marking and instructions were provided. |
YY/T 0270.2-2011: Dentistry. Base polymers. Part 2: Orthodontic base polymers---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.Base polymers.Part 2. Orthodontic base polymers
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
Dentistry denture base polymer
Part 2. Orthodontic denture base polymer
(ISO 20795-2.2010, IDT)
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 Category 2
5 Requirement 2
5.1 unpolymerized material 2
5.2 polymeric material 2
Sampling 4 6
7 specimen and sample preparation 4
7.1 Test Environment 4
7.2 Step 5
7.3 Special equipment 5
Test Method 8 5
8.1 Compliance Checking 5
8.2 Color 5
8.3 polished performance, non-porous, ultimate flexural strength and flexural modulus of elasticity of 5
8.4 with improved bend fracture toughness test measured 8
8.5 residual methyl methacrylate monomer 11
8.6 plasticizer, if applicable 16
8.7 absorption and dissolution 18
Claim 9 labels, signs, packaging and instructions 20
9.1 Packaging 20
Logo and packaging containers 21 9.2
9.3 Manufacturer's Manual 21
Appendix A (normative) high pressure liquid chromatography (HPLC) measured MMA content 23
References 25
Foreword
YY 0270 "dentistry denture base polymer" is divided into two parts.
--- Part 1. denture base polymer;
--- Part 2. Orthodontic denture base polymer.
This is Part 2.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 20795-2.2010 "dentistry denture base polymers - Part 2. Orthodontic denture Poly
Thereof. "
Consistency correspondence between this part of international documents and normative references of our files are as follows.
--- 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 8601.2004,
IDT)
--- GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)]
--- YY 0270.1-2011 dentistry denture base polymers - Part 1. denture base polymers (ISO 20795-1.2008,
IDT)
--- YY measurement/T 0631-2008 dental materials color stability (ISO 7491.2000, IDT)
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 part is proposed by the State Food and Drug Administration.
The oral part of the National Standardization Technical Committee materials and appliances and equipment (SAC/TC99) and focal points.
This part mainly drafted by. Peking University School of Stomatology, medical equipment and test center.
This section involved in the drafting unit. Sichuan biomaterials and medical devices products inspection center (Sichuan University).
The main drafters of this section. Zheng Gang, Zhang Dianyun, Xu Yongxiang, Lin Hong, Wang Yaning, Deng Xiang, He Ming Ming, Zhang.
Introduction
Over the years, methacrylic polymer materials are widely used in the production of active and passive removable orthodontic appliance. These removable orthodontic
Appliance orthodontic treatment mainly for children. There are some potential problems with the production method of orthodontic appliance polymer part by polymerizing
Process and polymer/monomer ratio impact, removable orthodontic appliance of the polymer portion of the performance to be worse than the use of traditional boxing heating
Aggregation made of denture base polymer. Compared with the heat-curable denture base polymer materials, orthodontic appliance residual monomer content
And other impurities more and more dangerous. In addition, high monomer content of the polymer/monomer ratio may result in increased shrinkage of the polymer.
ISO 20795 does not include qualitative and quantitative requirements for biological hazards, but it is strongly recommended to assess possible biological or
When toxicological hazards, referring to GB/T 16886 and YY/T 0268.
Dentistry denture base polymer
Part 2. Orthodontic denture base polymer
1 Scope
This section applies to the production of active/passive orthodontic appliance orthodontic denture base polymers and copolymers, and sets out its requirements.
Also specifies the test method for determination of compliance with these requirements. Meanwhile, the companion material provide product packaging, labeling and instruction manual
It has been stipulated.
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 0270.1-2011 dentistry denture base polymers - Part 1. denture base polymers (ISO 20795-1.2008, IDT)
ISO 1942 oral vocabulary (Dentistry-Vocabulary)
ISO 3696 for analytical laboratory use specifications and test methods (Waterforanalyticallaboratoryuse-Specification
andtestmethods)
ISO 7491 Determination of color stability of dental materials (Dentalmaterials-Determinationofcolourstability)
ISO 8601 Data elements and interchange formats - Information interchange the date and time notation (Dataelementsandinterchange
formats-Informationinterchange-Representationofdatesandtimes)
3 Terms and Definitions
As defined in ISO 1942 and the following terms and definitions apply to this document.
3.1
Self-curing material autopolymerizablematerials
Initiating polymerization by a chemical method, without heating to a temperature above 65 deg.] C to complete the polymerization of the material.
3.2
Duisu technology builduptechnique
sprayontechnique
On the working model gradually filling liquid and powder until a desired shape.
3.3
Packaging immediatecontainer
Direct contact with (orthodontic) base material in the container.
3.4
Photo-curable polymer lightactivatedpolymers
By an external source, such as the energy of visible light to initiate polymerization products.
3.5
Liquid liquid
After mixing the polymer particles, a monomer capable of forming a liquid or doughy plasticity fluidity of the resin mixture, for making orthodontic
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