YY/T 0809.2-2020 Active Industry standards-Medicine

YY/T 0809.2-2020 Implants for surgery—Partial and total hip joint prostheses—Part 2:Articulating surfaces made of metallic,ceramic and plastics materials

YY/T 0809.2-2020 Implants for surgery—Partial and total hip joint prostheses—Part 2:Articulating surfaces made of metallic,ceramic and plastics materials

Publish Date: 2020-09-27 Implement Date: 2021-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0809.2-2020

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: 2020-09-27

Implement Date: 2021-09-01

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骨科植入物分技术委员会(SAC/TC 110/SC 1)

Pages: 9 pages

Scope

YY/T 0809的本部分规定了具有球臼结构的各类全髋和部分髋关节假体关节面的要求，包括：
a)YY/T 0809.1-2010中分类a)中部分髋关节置换术用金属及陶瓷股骨假体部件的球度及表面粗糙度要求；
b)YY/T 0809.1-2010中分类a)中连接到股骨部件的塑料内表面和连接到生理髋臼的金属或陶瓷外表面双极股骨头球度及表面粗糙度要求；
c)YY/T 0809.1-2010中分类b)中塑料髋臼部件的球度及表面粗糙度要求和尺寸公差；
d)YY/T 0809.1-2010中分类c)中全髋关节假体金属或陶瓷股骨部件的球度及表面粗糙度要求和尺寸公差。
本部分适用于具有球臼结构的各类全髋和部分髋关节假体关节面。

Development Information

Drafting Units:

天津市医疗器械质量监督检验中心、国家药品监督管理局医疗器械技术审评中心、北京纳通科技集团有限公司、苏州微创关节医疗科技有限公司、萨摩医疗科技(北京)有限公司

Drafting Persons:

李楠、董双鹏、付瑞芝、郭晓磊、甄珍、赵文文、李仁耀、石薇、俞天白、梁芳慧

Word Count: 16 Thousand words Pages: 9 pages

Same series standard

YY/T 0809.12-2020 Implants for surgery—Partial and total hip joint prostheses—Part 12:Deformation test method for acetabular shells YY/T 0809.13-2020 Implants for surgery—Partial and total hip joint prostheses—Part 13:Determination of resistance to torque of head fixation of stemmed femoral components

Replace the following standards

YY/T 0809.2-2010 Implants for surgery—Partial and total hip joint prostheses—Part 2:Articulating surfaces made of metallic,ceramic and plastics materials

Referenced Standards

GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture YY/T 0809.1-2010 Implants for surgery—Partial and total hip joint prostheses—Part 1:Classification and designation of dimensions GB/T 3505-2000 Geometrical product specifications (GPS)—Surface texture:Profile method—Terms, definitions and surface texture parameters GB/T 3505-2009 Geometrical Product Specifications (GPS)—Surface texture:Profile method—Terms,definitions and surface texture parameters

Adopt standards

ISO 7206-2:2011 ISO 7206-2:2011/AMD 1:2016

Related Standards

GB 12264-1990 Replaced

GB 12264-1990 Artificial heart-lung machine Silicon rubber pump tube

Publish Date: 1990-01-08

GB 12279-1990 Replaced

GB 12279-1990 Cardiac valve prostheses general technical specification

Publish Date: 1990-03-26

GB 12417-1990 Replaced

GB 12417-1990 The general technological conditions of surgical metal implant

Publish Date: 1990-07-17

GB/T 13461-1992 Replaced

GB/T 13461-1992 Synthetic resin blow knee prostheses

Publish Date: 1992-06-01

GB/T 14191-1993 Replaced

GB/T 14191-1993 Terminology for prosthetics and orthotics

Publish Date: 1993-02-25

GB 14722-1993 Replaced

GB 14722-1993 Endoskeletal above knee prosthesis

Publish Date: 1993-12-04