|
US$449.00 ยท In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1936-2024: Customized fixed prosthesis
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1936-2024 | English | 449 |
Add to Cart
|
4 days [Need to translate]
|
Customized fixed prosthesis
| Valid |
YY/T 1936-2024
|
PDF similar to YY/T 1936-2024
Basic data | Standard ID | YY/T 1936-2024 (YY/T1936-2024) | | Description (Translated English) | Customized fixed prosthesis | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 22,247 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Issuing agency(ies) | State Drug Administration | YY/T 1936-2024: Customized fixed prosthesis---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 fixed 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 Categories 2
5 Naming Rules 2
6 Requirement 2
7 Preparation of samples 5
8 Test methods 6
9 Inspection Rules 9
10 Marking and accompanying documents10
11 Packaging, transportation and storage 11
Appendix A (Normative) Requirements for custom fixed denture models 12
Appendix B (Informative) Customized fixed denture metal internal quality inspection method 13
Reference 14
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. West China School of Stomatology, Sichuan University, and Peking University School of Stomatology.
The main drafters of this document are. Yu Haiyang, Yue Li, Zheng Liwei, Yu Na, Hu Xiaoyang, Lin Hong, Zheng Gang, Yan Chunxi, Bai Wei, Zhang Na, Ren Wei,
Zhou Min.
Introduction
The main technical indicators of this document are determined based on long-term clinical experience.
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 fixed dentures must have obtained a medical device product registration certificate, this document will no longer involve
Evaluation of biocompatibility.
Considering that some denture manufacturers currently produce custom fixed dentures, the crown and bridge base (including metal base and zirconia base)
The crown and bridge base is shipped as the final product, therefore, this document incorporates the requirements for the crown and bridge base.
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 fixed dentures
1 Scope
This document specifies the requirements for custom-made fixed dentures and describes the corresponding test methods.
This document is applicable to customized fixed dentures and crown and bridge bases (including metal bases and zirconia bases) shipped as products.
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
GB 30367-2013 Dental ceramic materials
YY 0300-2009 Artificial teeth for dental restoration
YY/T 0462-2018 Dental plaster products
YY 0621.1-2016 Dental matching test Part 1.Metal-ceramic system
YY/T 0621.2-2020 Dental matching test Part 2.Ceramic-ceramic system
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.
Providing medical institutions with restorations that can restore the morphology, function and aesthetics of patients' tooth defects, edentulous 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 fixed in the patient's mouth by bonding or other retention forces. Once the restoration is put in, the patient cannot take it off by himself.
Dentures.
3.4
fixed bridge
Use the natural teeth near and far from the missing teeth as abutments to repair one or more missing natural teeth in the dentition defect and restore its anatomical shape.
and physiological function of fixed dentures.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1936-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 1936-2024_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 1936-2024_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1936-2024_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+ countriesQuestion 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.
|