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YY/T 1819-2022: Dentistry - Diaphragm for orthodontic aligner
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| YY/T 1819-2022 | English | 259 |
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Dentistry - Diaphragm for orthodontic aligner
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YY/T 1819-2022
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Basic data | Standard ID | YY/T 1819-2022 (YY/T1819-2022) | | Description (Translated English) | Dentistry - Diaphragm for orthodontic aligner | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Word Count Estimation | 12,195 | | Issuing agency(ies) | State Drug Administration | YY/T 1819-2022: Dentistry - Diaphragm for orthodontic aligner---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 - Diaphragm for orthodontic aligner
ICS 11.060.10
CCSC33
People's Republic of China Pharmaceutical Industry Standard
Diaphragms for orthodontic appliances
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
Please note that some content of this document may be patented. Publication of this document
Institutions should not be held responsible for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Dental Materials and Devices (SAC/TC99).
This document is drafted by. Peking University School of Stomatology Oral Medical Device Inspection Center, Shanghai Times Angel Medical Device Co., Ltd.
The main drafters of this document. Yuan Shenpo, Lin Hong, Huang Lei, Zheng Yikan, Xu Yongxiang, Zhang Dianyun.
Introduction
The diaphragms for orthodontic appliances are mostly thermoplastic polymers, which are processed by heating and pressure on the patient's model to make orthodontic appliances.
Orthodontic treatment.
The diaphragm for orthodontic appliances is used to make orthodontic appliances, usually a single orthodontic appliance is used for about 2 weeks, and the whole set of orthodontic appliances is used for orthodontic appliances.
The use time of the device is 1 to 2 years.
This document does not apply to the performance evaluation of orthodontic appliances. Nor does it represent an orthodontic appliance made with a diaphragm that complies with this document
The clinical treatment effect is effective.
This document does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended that when evaluating possible biological hazards, refer to
GB/T 16886.1 and YY/T 0268.
Diaphragms for orthodontic appliances
1 Scope
This document specifies the performance requirements and experimental methods of diaphragms for orthodontic appliances, as well as packaging and labeling information.
This document applies to diaphragms for orthodontic appliances.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 1040.3-2006 Determination of Tensile Properties of Plastics Part 3.Test Conditions for Films and Sheets
GB/T 5478 Test method for rolling wear of plastics
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
GB/T 9937 dental terminology
GB/T 33047.1-2016 Thermogravimetric method (TG) of plastic polymers - Part 1.General
QB/T 1130-1991 Test method for right-angle tearing properties of plastics
3 Terms and Definitions
The terms and definitions defined in GB/T 9937 and the following apply to this document.
3.1
orthodontic aligner
A device for the treatment of malocclusion, which can generate force to change the deformed jaw, misplaced teeth and periodontal supporting tissue to facilitate
Dental and maxillofacial normal growth and development.
3.2
grindingwheel
A small grinding wheel or a wheel with sandpaper used to abrade the material.
3.3
wearabrasivewear
Loss of material contact surface due to the scraping action of the grinding wheel.
4 Requirements
4.1 Appearance
The outer surface should be smooth and free from visible impurities, stains, cracks, cracks, blisters, sharp edges, burrs, pores, scratches and other defects.
4.2 Odour
There should be no irritating odor.
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