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YY 0621-2025 English PDF

YY 0621: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY 0621-2025RFQ ASK 3 days (Dentistry - Compatibility test of metal-ceramic and ceramic-ceramic systems) Valid
YY 0621.1-2016199 Add to Cart 3 days Dentistry. Compatibility testing. Part 1: Metal-ceramic systems Valid
YY 0621-2008559 Add to Cart 3 days Metal-ceramic dental restorative systems Obsolete


Basic data

Standard ID: YY 0621-2025 (YY0621-2025)
Description (Translated English): (Dentistry - Compatibility test of metal-ceramic and ceramic-ceramic systems)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Date of Issue: 2025-06-18
Date of Implementation: 2028-07-01
Older Standard (superseded by this standard): YY 0621.1-2016, YY/T 0621.2-2020
Issuing agency(ies): National Medical Products Administration

YY 0621.1-2016: Dentistry. Compatibility testing. Part 1: Metal-ceramic systems

---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.
Dentistry.Compatability testing.Part 1. Metal-ceramic systems ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standard YY 0621.1-2016/ISO 9693-1..2012 Replacing YY 0621-2008 Dental Matching Test Part 1. metal - ceramic systems Part 1. Metal-ceramicsystems (ISO 9693-1..2012, IDT) 2016-01-26 release 2018-01-01 implementation State Food and Drug Administration issued

Foreword

The technical content of this standard is mandatory. YY 0621 "Dental Matching Test" is divided into two parts. - Part 1. Metal - ceramic systems; Part 2. Ceramic - ceramic systems. This part is part 1 of YY 0621. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part of the part of the replacement YY 0621-2008 "dental metal porcelain repair system." This section is the main change compared with YY 0621-2008 for the following reasons. YY 0621-2008 "dental metal porcelain repair system" in the dental metal and dental ceramic material content, have been based on ISO 22674 and ISO 6872 to GB 17168-2013 "Dental fixation and active prostheses and metal materials for dental instruments" And GB 30367-2013 "Dental Ceramics", this part of this standard only retains the metal-ceramic horses in YY 0621-2008 The content of sex. This part uses the translation method equivalent to ISO 9693-1..2012 "Dental Matching Test Part 1. Metal - Ceramic Systems". Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This part is headed by the National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC99). This part is responsible for the drafting unit. State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center, Nanjing Medical University College of Medicine. This part of the main drafters. Bai Wei, Lin Hong, Sun Zhihui, Zheng Gang, Chen Yaming. This part of the previous release is. --- YY 0621-2008. YY 0621.1-2016/ISO 9693-1..2012

Introduction

This part deals with dental metal materials and ceramics for the production of dental metal-ceramic restorations. The requirements for metallic materials are made by GB 17168 gives the requirements for ceramic materials given by GB 30367. YY 0621.1-2016/ISO 9693-1..2012 Dental Matching Test Part 1. metal - ceramic systems

1 Scope

YY 0621 this part of the provisions of the dental repair by testing the metal and ceramic composite structure, to determine the match between the two test Test method. The performance requirements of this section apply to metal and ceramic materials that are used together, and are not intended for use solely with metal or ceramic material.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all revisions) applies to this document. GB 17168-2013 Metal materials for dental fixation and activity restoration (ISO 22674..2006, IDT) GB 30367-2013 Dental Ceramics (ISO 6872..2008, IDT) ISO 1942 Dentalistry Vocabulary (Dentistry-Vocabulary)

3 Terms and Definitions

The terms and definitions defined in ISO 1942, GB 30367 and GB 17168 apply to this document.

4 requirements

4.1 Biocompatibility This section does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended that, in assessing possible biological hazards, reference ISO 10993-1 and ISO 7405. 4.2 Properties of metal-ceramic systems The peel strength of the metallic material and at least one specified ceramic material should be greater than 25 MPa. Ceramic material with at least one finger The peel strength of the metal material should be greater than 25MPa. The test is carried out according to 6.4.

5 sampling

5.1 Metal materials The sample size should be sufficient to meet the requirements of 6.4.2 for the preparation of the test sample. The samples taken should be of the same batch, unused metal material. YY 0621.1-2016/ISO 9693-1..2012
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