HOME Cart(0) Quotation About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (19 Oct 2025)

YY/T 1932-2024 English PDF

US$449.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1932-2024: Dentistry - Dental splint bracketless orthodontic aligner
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1932-2024	English	449	Add to Cart	4 days [Need to translate]	Dentistry - Dental splint bracketless orthodontic aligner	Valid	YY/T 1932-2024

PDF similar to YY/T 1932-2024

Standard similar to YY/T 1932-2024

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

Basic data

Standard ID	YY/T 1932-2024 (YY/T1932-2024)
Description (Translated English)	Dentistry - Dental splint bracketless orthodontic aligner
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C33
Classification of International Standard	11.060.10
Word Count Estimation	22,286
Date of Issue	2024-07-08
Date of Implementation	2025-07-20
Issuing agency(ies)	State Drug Administration

YY/T 1932-2024: Dentistry - Dental splint bracketless 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.
ICS 11.060.10 CCSC33 Pharmaceutical Industry Standards of the People's Republic of China Dental diaphragm bracketless orthodontic appliance Released on 2024-07-08 2025-07-20 Implementation The State Drug Administration issued

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 2 4.1 General 2 4.2 Physical and chemical properties 2 4.3 Other requirements 3 5 Test methods 3 5.1 Test conditions 3 5.2 Appearance 3 5.3 Color 4 5.4 Odor 4 5.5 Coverage 4 5.6 Edge thickness 4 5.7 Fit 4 5.8 3D printed dental model size 4 5.9 Appliance size 6 5.10 Clamping force 7 5.11 pH 9 5.12 Total heavy metal content (measured in lead) 9 5.13 Evaporation residue 9 5.14 Reducing substances (oxidizable substances) 9 6 Information for Users 9 6.1 General requirements 9 6.2 Instructions for use 9 6.3 Label 10 Appendix A (Normative) Standard 3D printing model and clamping force test fixture model 11 A.1 Standard 3D printing model 11 A.2 Clamping force test fixture model 14 References 16

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 for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Instruments (SAC/TC99). This document was drafted by. Oral Medical Device Testing Center, Peking University School of Stomatology, Shanghai Angelalign Medical Devices Co., Ltd., Sichuan Medical Device Biomaterials and Products Inspection Center Co., Ltd. The main drafters of this document are. Bai Wei, Li Huamin, Huang Lei, Zheng Yikan, Lin Hong, Cheng Dongqin and Wu Minhua.

Introduction

Diaphragm-type bracketless orthodontic appliances are made of thermoplastic polymer diaphragms, which are processed by heating and pressurizing on the patient's tooth model. Used for orthodontic treatment of patients' dental deformities. Since the membrane type bracketless orthodontic appliance is usually made on a 3D printed dental model, this document only In addition to stipulating the general requirements for brackets and orthodontic appliances, it also sets requirements for 3D printed dental models that affect their quality. This document does not include qualitative and quantitative test methods for demonstrating that materials do not present an unacceptable biological risk, such as the assessment of such biological Risks can be referred to GB/T 16886.1 and YY/T 0268. This document does not include regulations on the monitoring of the entire medical-engineering interaction process of diaphragm-type bracketless orthodontic appliances and the determination of indicators and acceptance conditions. Dental diaphragm bracketless orthodontic appliance

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 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.

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1932-2024_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1932-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1932-2024_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1932-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.