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YY/T 1932-2024Dentistry - Bracketless orthodontic aligner (English PDF)

牙科学膜片式无托槽正畸矫治器

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

July 8, 2024

Implementation date

July 20, 2025

Scope

YY/T 1932-2024 is the English-translated version of 牙科学膜片式无托槽正畸矫治器.

YY/T 1932-2024 is the Chinese standard "Dentistry - Bracketless orthodontic aligner". Its scope clause reads: This document specifies the performance requirements, tests and Evaluation methods, labeling and product instruction manual information.

This document applies to diaphragm-type bracketless orthodontic appliances. Note. In order to avoid confusion, "diaphragm-type bracketless orthodontic appliance" in this document is referred to as "appliance". Its clauses include terms and definitions.

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Document preview — YY/T 1932-2024

National Standard of the People's Republic of China

ICS: 11.060.10
Classification: C33

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Requirement
4.1 General
4.2 Physical and chemical properties
4.3 Other requirements
5 Test methods
5.1 Test conditions
5.2 Appearance
5.3 Color
5.4 Odor
5.5 Coverage
5.6 Edge thickness
5.7 Fit
5.8 3D printed dental model size
5.9 Appliance size
5.10 Clamping force
5.11 pH
5.12 Total heavy metal content (measured in lead)
5.13 Evaporation residue
5.14 Reducing substances (oxidizable substances)
6 Information for Users
6.1 General requirements
6.2 Instructions for use
6.3 Label
Appendix A (Normative) Standard 3D printing model and clamping force test fixture model
References

1 Scope

This document specifies the performance requirements, tests and

Evaluation methods, labeling and product instruction manual information.

This document applies to diaphragm-type bracketless orthodontic appliances.

Note. In order to avoid confusion, "diaphragm-type bracketless orthodontic appliance" in this document is referred to as "appliance".

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to

This document.

GB/T 6682 Specifications and test methods for water used in analytical laboratories

GB/T 9937 Dental terminology

GB/T 14233.1-2022 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods

GB/T 24762-2009 Product geometry technical specification (GPS) Image measuring instrument acceptance test and re-test

YY/T 1819 Diaphragms for orthodontic appliances in dentistry

3 Terms and definitions

The terms and definitions defined in GB/T 9937 and the following apply to this document.

3.1

A series of custom-made braces made of thermoplastic polymer membranes, which are worn on the teeth and the membranes rebound to shift the teeth, thereby achieving

Removable orthodontic appliances for treating dental malocclusion.

3.2

3D-printeddentalmodel

A model made of resin material through additive manufacturing (3D printing) with the same shape as the patient's jaw shape. Used as a diaphragm for hot pressing

Molding mold.

3.3 Initial holding force

The initial pressure applied to the diaphragm-type bracketless orthodontic appliance specimen using a pressure-generating fixture.

3.4

A continuous pressure is applied to the specimen of the diaphragm-type bracketless orthodontic appliance using a pressure-generating fixture.

3.5 Anti-stain property

The ability of diaphragm-type bracketless orthodontic appliances to resist staining when in contact with colored drinks or foods.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1691|YY/T 1692|YY/T 1702|YY/T 1937|YY/T 1936

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