GB 12264-1990
Replaced
YY/T 0772.4-2022
Active
Industry standards-Medicine
YY/T 0772.4-2022 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 4:Oxidation index measurement method
YY/T 0772.4-2022 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 4:Oxidation index measurement method
Basic Information
Standard Code:
YY/T 0772.4-2022
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:
2022-08-17
Implement Date:
2023-09-01
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(SAC/TC 110)
Pages:
16 pages
Scope
本文件规定了超高分子量聚乙烯相对氧化程度的测试方法。
本文件适用于外科植入物用超高分子量聚乙烯。
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、苏州微创关节医疗科技有限公司、帝斯曼(中国)有限公司、大博医疗科技股份有限公司、史赛克(北京)医疗器械有限公司、施乐辉医用产品国际贸易(上海)有限公司
Drafting Persons:
姜熙、张旺、付瑞芝、张娜、郭增越、孙嘉怿、李晓云、俞天白、李炫、王慧萍、曾达、林志雄、张海明、张松伟、李晨曦、郝瑞星
Replace the following standards
YY/T 0772.4-2009
Referenced Standards
GB/T 19701.2-2005 Implants for surgery Ultra-high molecular weight polyethylene—Part 2:Moulded forms
GB/T 19701.2-2016 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2:Moulded forms
GB/T 21461.1-2008 Plastics—Ultra-high-molecular-weight polyethylene(PE-UHMW)moulding and extrusion materials—Part 1:Designation system and basis for specifications
GB/T 21461.1-2023 Plastics—Ultra-high-molecular-weight polyethylene (PE-UHMW)moulding and extrusion materials—Part 1:Designation system and basis for specifications
GB/T 21461.2-2008 Plastics—Ultra-high-molecular-weight polyethylene(PE-UHMW)moulding and extrusion materials—Part 2:Preparation of test specimens and determination of properties
GB/T 21461.2-2023 Plastics—Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials—Part 2:Preparation of test specimens and determination of properties
GB/T 19701.2-2024 Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 2:Moulded forms
Adopt standards
ISO 5834-4:2019
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