YY/T 0270.2-2011Dentistry—Base polymers - Part 2: Orthodontic base polymers (English PDF)
牙科学 基托聚合物 第2部分:正畸基托聚合物
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 0270.2-2011 is the English-translated version of 牙科学 基托聚合物 第2部分:正畸基托聚合物.
YY/T 0270.2-2011 is the Chinese pharmaceutical industry standard for the orthodontic base polymers and copolymers used to make the base of an active or passive orthodontic appliance.
It is the second part of the YY/T 0270 series and sets the requirements for these materials and the test methods by which compliance is determined, and it fixes what the packaging, the labelling and the instruction manual supplied with the material must contain. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY/T 0270.2-2011
National Standard of the People's Republic of China
- ICS
- 11.060.10
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
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)
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
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
By an external source, such as the energy of visible light to initiate polymerization products.
3.5 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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 1942 · ISO 3696 · ISO 7491 · ISO 8601
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