YY/T 1715-2020 Active Industry standards-Medicine

YY/T 1715-2020 Implants for surgery—Ceramic materials based on yttria-stabilized tetragonal zirconia(Y-TZP)

Publish Date: 2020-06-30 Implement Date: 2021-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1715-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2020-06-30

Implement Date: 2021-06-01

Publisher: 国家药品监督管理局

Technical Committee: 全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)

Pages: 14 pages

Scope

本标准规定了外科植入物用生物相容和生物稳定的氧化钇稳定四方氧化锆（氧化钇四方氧化锆多晶体，Y-TZP）陶瓷骨替代材料的要求和相应的测试方法。
本标准适用于外科植入物用氧化钇稳定四方氧化锆(Y-TZP)陶瓷材料。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、清华大学核能与新能源技术研究院、北京固圣生物科技有限公司

Drafting Persons:

马春宝、安俊波、田杰谟、王晨、张琳、曹小刚

Word Count: 28 Thousand words Pages: 14 pages

Referenced Standards

GB/T 16825.1-2008 Verification of static uniaxial testing machines—Part 1:Tension/compression testing machines—Verification and calibration of the force-measuring system ISO 3611 ISO 13383-1 ISO 17561 ISO 20501 ISO 22214 GB/T 6003.1-1997 Test sieves of metal wire cloth GB/T 6003.1-2012 Test sieves—Technical requirements and testing—Part 1:Test sieves of metal wire cloth GB/T 6003.1-2022 Test sieves—Technical requirements and testing—Part 1:Test sieves of metal wire cloth GB/T 6569-1986 Testing method for flexural strength of high performance ceramics GB/T 6569-2006 Fine ceramics(advanced ceramics,advanced technical ceramics)—Test method for flexural strength of monolithic ceramics at room temperature GB/T 16534-1996 Test method for Vickers hardness of high performance ceramics GB/T 16534-2009 Fine ceramics(advanced ceramics,advanced technical ceramics)—Test method for hardness of monolithic ceramics at room temperature GB/T 25995-2010 Test methods for density and apparent porosity of fine ceramics

Adopt standards

ISO 13356:2015

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