YY/T 1819-2022Dentistry-Diaphragm for orthodontic aligner (English PDF)
牙科学 正畸矫治器用膜片
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 18, 2022
Implementation date
June 1, 2023
Scope
YY/T 1819-2022 is the English-translated version of 牙科学 正畸矫治器用膜片.
YY/T 1819-2022 is the Chinese pharmaceutical industry standard for the thermoplastic sheet from which clear orthodontic aligners are formed.
It sets the performance requirements and the test methods for the sheet, covering the identification of the polymer, the thickness and its uniformity, the transparency and colour, the mechanical behaviour in tension and the stress relaxation that governs how long a force is held, the behaviour after thermoforming, the water absorption and the biological evaluation, together with the packaging and the information that must be given with it. Issued on 18 May 2022, it has applied since 1 June 2023.
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Document preview — YY/T 1819-2022
National Standard of the People's Republic of China
- 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
- 4 Requirements
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.
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
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1040.3-2006Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets
- GB/T 5478Plastics -- Test method for wear by rolling
- GB/T 6682Water for analytical laboratory use - Specification and test methods
- GB/T 9937Dentistry - Vocabulary
- GB/T 33047.1-2016Plastics - Thermogravimetry (TG) of polymers - Part 1: General principles
QB/T 1130-1991
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Related Standards
GB/T 1040.3-2006 — Plastics -- Determination of tensile properties -- Part 3: Test conditions for films and sheets
GB/T 5478-2008 — Plastics -- Test method for wear by rolling
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
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