YY/T 1937-2024 English PDF

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YY/T 1937-2024: Customized removable denture
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1937-2024	449	Add to Cart	4 days	Customized removable denture	Valid

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Basic data

Standard ID: YY/T 1937-2024 (YY/T1937-2024)
Description (Translated English): Customized removable denture
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Word Count Estimation: 22,234
Date of Issue: 2024-07-08
Date of Implementation: 2025-07-20
Issuing agency(ies): State Drug Administration

YY/T 1937-2024: Customized removable denture

---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 Customized removable dentures Released on 2024-07-08 2025-07-20 Implementation The State Drug Administration issued

Table of Contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Classification and naming 4 5 Structure 4 6 Requirements 5 7 Sample preparation 7 8 Test methods 9 9 Inspection Rules 12 10 Marking and accompanying documents12 11 Packaging, transportation and storage 13 Appendix A (Normative) Requirements for custom removable denture models 14 Appendix B (Informative) Customized removable denture metal internal quality inspection method 15 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, Instruments and Equipment (SAC/TC99). This document was drafted by. West China School of Stomatology, Sichuan University, and Peking University School of Stomatology. The main drafters of this document are. Yue Li, Yu Haiyang, Zheng Liwei, Hu Xiaoyang, Zheng Gang, Lin Hong, Yan Chunxi, Bai Wei, Zhang Na, Dong Bo, Zhou Min.

Introduction

The main technical indicators of this document are determined based on actual clinical usage. In theory, the laboratory tests in the appendix to this document also need to consider the following factors. functionality, durability and tear resistance, the development of new materials The impact of these factors on the environment and the activities of users as part of the assessment process. Needs to be constantly replenished. Since this document stipulates that the raw materials used in customized removable dentures must have obtained a medical device product registration certificate, this document will no longer involve Evaluation of biocompatibility. There are many methods for testing the internal quality of metals. Appendix B of this document lists other methods for testing the internal quality of metals for reference. However, these methods have their own limitations when used for internal quality inspection of customized denture metal. With the development of metal internal quality inspection methods, new inspection methods may be replaced by new inspection methods. Customized removable dentures

1 Scope

This document specifies the requirements for custom-made removable dentures and describes the corresponding test methods. This document applies to custom-made removable dentures.

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 9937-2020 Dental terminology GB 17168-2013 Metal materials for fixed and removable restorations in dentistry YY 0270.1-2011 Dental base polymers Part 1.Denture base polymers YY 0300-2009 Artificial teeth for dental restoration YY/T 0462-2018 Dental plaster products YY/T 1702-2020 Additive manufacturing of dental fixed and removable restorations using laser selective melting of metal materials

3 Terms and definitions

The terms and definitions defined in GB/T 9937-2020 and the following apply to this document. 3.1 Customized denture customizeddenture Denture manufacturers use dental materials to carry out restoration design and production according to the patient model and the requirements of the design sheet. Medical institutions provide restorations that can restore the morphology, function and aesthetics of patients' tooth defects, edentulous spaces and missing teeth. Note. Includes customized fixed dentures and customized removable dentures. 3.2 Restoration Dental medical devices used to restore or replace missing tooth structure, teeth or oral tissue. 3.3 It is used to repair the patient's tooth defects or missing teeth, using the natural teeth and the mucosa and bone tissue covered by the base as support, using the retainer and base The restoration is well-retained and can be removed and put on by the patient. Note. Includes removable partial dentures and complete dentures. 3.4 A removable denture that replaces only some of the teeth in one arch, but not all of them. 3.5 Complete denture Removable dentures for maxillary or mandibular edentulous patients. ......

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