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YY/T 0621.2-2020: Dentistry--Compatibility testing - Part 2: Ceramic-ceramic systems
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Dentistry--Compatibility testing - Part 2: Ceramic-ceramic systems
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YY/T 0621.2-2020
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Basic data | Standard ID | YY/T 0621.2-2020 (YY/T0621.2-2020) | | Description (Translated English) | Dentistry--Compatibility testing - Part 2: Ceramic-ceramic systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 12,178 | | Date of Issue | 2020 | | Date of Implementation | 2021-03-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance requirements and test methods for evaluating the compatibility of ceramic-ceramic materials for dental restorations by testing the composite structure of the two. The requirements of this standard apply to ceramic materials used in combination with ceramics of different compositions, but not to ceramic materials used alone. This standard replaces YY 0621-2008 "Dental Metal-Porcelain Restoration System". | YY/T 0621.2-2020: Dentistry--Compatibility testing - Part 2: Ceramic-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--Compatibility testing--Part 2. Ceramic-ceramic systems
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0621-2008
Dentistry matching test
Part 2. Ceramic-ceramic system
(ISO 9693-2..2016, IDT)
Published on February 25, 2020
2021-03-01 implementation
Issued by the State Drug Administration
Foreword
YY 0621 "Dental Science Matching Test" is divided into 2 parts.
--- Part 1. Metal-ceramic system;
--- Part 2. Ceramic-ceramic system.
This part is part 2 of YY 0621.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Together with YY 0621.1, this part replaces YY 0621-2008 "Dental Metal Porcelain Restoration System".
The relationship between this part and YY 0621-2008. the original YY 0621-2008 "Dental metal porcelain restoration system" is a metal-ceramic body
Department of content. There is no reference to ceramic-ceramic matching. YY 0621-2008 about dental metal and dental ceramic materials,
It has been converted to GB 17168-2013 "Metal Materials for Dental Surgery and Restoration" according to ISO 22674 and ISO 6872 respectively
And GB 30367-2013 "Dental Science Ceramic Materials"; YY 0621.1 only retains the metal-ceramic matching in YY 0621-2008
The content; and this part is not related to the original YY 0621-2008, ceramic-ceramic matching content.
This part uses the translation method to be equivalent to ISO 9693-2..2016 "Dental Science Matching Test Part 2. Ceramic-Ceramic System"
Compared with ISO 9693..1999, the main changes in this part are as follows.
This part retains the determination of the thermal expansion coefficient of ceramic materials in ISO 9693..1999, and adds the matching test of ceramic-ceramic materials.
Peel/sprouting crack test and thermal shock test.
The documents in China that have a consistent correspondence with the normatively cited international documents in this section are as follows.
--- GB/T 9937 (all parts) oral vocabulary (ISO 1942, IDT);
--- GB 30367-2013 Ceramic materials for dentistry (ISO 6872..2008, IDT).
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee on Dental Materials and Devices (SAC/TC99).
This section was drafted by. Peking University School of Stomatology, Stomatological Medical Device Inspection Center, Liaoning Altron Biomaterials Co., Ltd.
The main drafters of this section. Bai Wei, Zhou Yongsheng, Lin Hong, Wu Yang, He Lingling, Li Jialing.
The previous versions of the standard replaced by this part are released as follows.
--- YY 0621-2008.
Introduction
Dental porcelain and base porcelain are suitable for preparing all-ceramic restorations. If functioning as a denture structure, the two
Matching under heat load is very important.
This section gives the requirements and test methods for evaluating the risks associated with chewing force and oral environment.
Dentistry matching test
Part 2. Ceramic-ceramic system
1 Scope
This part of YY 0621 stipulates the evaluation of the matching of the two by testing the composite structure of ceramic-ceramic materials for dental restoration
Requirements and test methods.
The requirements of this part apply to ceramic materials used in combination with ceramics of different compositions, but not to ceramics used alone
material.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
ISO 1942 Dentistry-Vocabulary
ISO 6872..2015 Dentistry-Ceramicmaterials
ISO 7405 Dentistry-Evaluation of biocompatibility of medical devices
usedindentistry)
ISO 10993 Biological evaluation of medical devices
3 Terms and definitions
The terms and definitions defined by ISO 1942 and ISO 6872..2015 and the following apply to this document.
3.1
Facing porcelain (ceramicveneer)
The entire structure of the sintered ceramic layer applied on the ceramic substrate.
3.2
Conditioning
The process of treating the base porcelain to increase its adhesion to the facing porcelain.
3.3
Liner
Applied to ceramic substrates, after sintering under appropriate time and temperature conditions, it can improve the aesthetics of the ceramic and/or increase the decorative porcelain and base
The bonding between the bottom porcelain surfaces.
4 requirements
4.1 Biocompatibility
This section does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended to refer to when evaluating possible biological hazards
ISO 10993 and ISO 7405.
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