GB 12264-1990
Replaced
YY/T 0924.2-2024
Active
Industry standards-Medicine
YY/T 0924.2-2024 Joint replacements—Components for partial and total knee joint prostheses—Part 2:Articulating surfaces made of metal,ceramic and plastics materials
YY/T 0924.2-2024 Joint replacements—Components for partial and total knee joint prostheses—Part 2:Articulating surfaces made of metal,ceramic and plastics materials
Basic Information
Standard Code:
YY/T 0924.2-2024
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:
2024-07-08
Implement Date:
2025-07-20
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:
12 pages
Scope
本文件规定了按YY/T 0924.1中分类的部分和全膝关节假体的关节面表面粗糙度的要求。
本文件适用于关节置换植入器械部分和全膝关节假体部件金属、陶瓷及塑料关节面表面粗糙度的评价。
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、国家药品监督管理局医疗器械技术审评检查大湾区分中心、大博医疗科技股份有限公司、苏州微创关节医疗科技有限公司
Drafting Persons:
李楠、李文娇、董双鹏、王颖、闵玥、孙嘉怿、张坤、卢敏琪、曾达、俞天白
Replace the following standards
Referenced Standards
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
GB/T 10610-1998 Geometrical product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
GB/T 10610-2009 Geometrical Product Specifications(GPS)—Surface texture:Profile method—Rules and procedures for the assessment of surface texture
YY/T 0924.1-2014 Implants for surgery—Components for partial and total knee joint prostheses—Part 1:Classification, definitions and designation of dimensions
Adopt standards
ISO 7207-2:2011+AMD 1:2016+AMD 2:2020
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced