GB 12264-1990
Replaced
GB/T 23101.4-2023
Active
National standards
GB/T 23101.4-2023 Implants for surgery—Hydroxyapatite—Part 4:Determination of coating adhesion strength
GB/T 23101.4-2023 Implants for surgery—Hydroxyapatite—Part 4:Determination of coating adhesion strength
Basic Information
Standard Code:
GB/T 23101.4-2023
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2023-11-27
Implement Date:
2024-12-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
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:
12 pages
Scope
本文件描述了预期用于外科植入物金属基体部件羟基磷灰石涂层的粘结强度试验方法。
注：检测实验室能力的要求见GB/T 27025—2019。
本文件适用于预期用于外科植入物金属基体部件羟基磷灰石涂层的粘结强度试验方法。
Development Information
Drafting Units:
史赛克(北京)医疗器械有限公司、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、四川大学、广东省医疗器械质量监督检验所、苏州微创关节医疗科技有限公司、大博医疗科技股份有限公司、北京纳通医疗科技控股有限公司、国合通用测试评价认证股份公司、苏州鼎安科技有限公司、施乐辉医用产品国际贸易(上海)有限公司
Drafting Persons:
张海明、张松伟、赵丙辉、王智杰、史新立、闵玥、韩丹、丁金聚、高进涛、李铮、邓翔、袁暾、刘珍珍、俞天白、李炫、曾达、彭海韵、董骧、李梅、翟亚楠、李成林、李亚东、李亚军、李晨曦、郝瑞星
Same series standard
Replace the following standards
Referenced Standards
ISO 5832-3
GB 4234.1-2017 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel
GB/T 16825.1-2002 Verification of static uniaxial testing machines—Part 1:Tension/compression testing machines—Verification and calibration of the force-measuring system
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
GB/T 16825.1-2022 Metallic materials—Calibration and verification of static uniaxial testing machines—Part 1:Tension/compression testing machines—Calibration and verification of the force-measuring system
GB/T 23101.3-2010 Implants for surgery—Hydroxyapatite—Part 3:Chemical analysis and characterization of crystallinity and phase purity
GB/T 23101.3-2023 Implants for surgery—Hydroxyapatite—Part 3:Chemical analysis and characterization of crystallinity ratio and phase purity
GB 4234.1-2026 Implants for surgery—Metallic materials—Part 1:Wrought stainless steel
Adopt standards
ISO 13779-4:2018
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