GB 12264-1990
Replaced
GB/T 24627-2023
Active
National standards
GB/T 24627-2023 Wrought nickel-titanium shape memory alloys for surgical implants
GB/T 24627-2023 Wrought nickel-titanium shape memory alloys for surgical implants
Basic Information
Standard Code:
GB/T 24627-2023
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:
2023-12-28
Implement Date:
2025-01-01
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:
16 pages
Scope
本文件规定了用于制造外科植入物,名义成分(质量分数)为54.5%~57.0%镍的镍-钛记忆合金棒材、板材和管材的化学、物理、机械和冶金要求。
注1: 用于制造其他医疗器械的镍钛记忆合金材料也参照本文件,使用方评估其适用性。
本文件适用于直径或厚度为5.5 mm~94.0 mm的轧制产品。
注2: 轧制产品不限定最终的形状、最终的表面状态或产品的最终性能。
注3: 冷加工管材成品参照YS/T 1136。
Development Information
Drafting Units:
有研医疗器械(北京)有限公司、天津市医疗器械质量监督检验中心、有研亿金新材料有限公司、江阴佩尔科技有限公司、西安思维智能材料有限公司、深圳市药品检验研究院(深圳市医疗器械检测中心)、先健科技(深圳)有限公司、西安华创新材料有限公司、上海沙烁新材料有限公司
Drafting Persons:
王振强、张宝祥、李立宾、李佳、陈庆福、杨晓康、杨涵、胡君源、牛中杰、袁志山、王江波、侯智超、廖赞、李君涛、张凯、文娜、刘洪伟、周小宵
Replace the following standards
Referenced Standards
YS/T 1064-2015 Terminology for nickel-titanium shape memory alloys
ASTM E1409
ASTM E1447
ASTM E1941
GB/T 228.1-2010 Metallic materials—Tensile testing—Part 1:Method of test at room temperature
GB/T 228.1-2021 Metallic materials—Tensile testing—Part 1:Method of test at room temperature
GB/T 4698.7-1996 Sponge titanium, titanium and titanium alloys—Determination of nitrogen content—Distillation—Nessler reagent spectrophotometric method
GB/T 4698.7-2011 Methods for chemical analysis of titanium sponge,titanium and titanium alloys—Determination of oxygen and nitrogen content
GB/T 4698.14-1996 Sponge titanium, titanium and titanium alloys—Determination of carbon content—Combustion coulometric method
GB/T 4698.14-2011 Methods for chemical analysis of titanium sponge,titanium and titanium alloys—Determination of carbon content
GB/T 4698.15-1996 Sponge titanium, titanium and titanium alloys—Determination of hydrogen content—Vacuum heating gas chromatographic method
GB/T 4698.15-2011 Methods for chemical analysis of titanium sponge,titanium and titanium alloys—Determination of hydrogen content
GB/T 6394-2002 Metal-methods for estimating the average grain size
GB/T 6394-2017 Determination of estimating the average grain size of metal
GB/T 16597-1996 Analytical methods of metallurgical products General rule for X-ray fluorescence spectrometric methods
GB/T 16597-2019 Analytical methods of metallurgical products—General rule for X-ray fluorescence spectrometric methods
GB/T 18876.1-2002 Standard practice for determining the metallographical constituent and inclusion content of steels and other metals by automatic image analysis—Part 1:Determining the inclusion or second-phase constituent content of steels and other metals by automatic image analysis and stereology
GB/T 18876.1-2024 Standard practice for determining the metallographical constituent and inclusion content of steels and other metals by automatic image analysis—Part 1:Determining the inclusion or second-phase constituent content of steels and other metals by automatic image analysis and stereology
GB/T 23614.1-2009 Methods for chemical analysis of titanium nickel shape memory alloy—Part 1:Determination of nickel content—Dimethylglyoxime precipitate separation-EDTA complex-zinc chloride back titration
YS/T 970-2014 Phase change temperature measuring method for nickel-titanium shape memory alloys
YY/T 0641-2008 Standard test method for transformation temperature of nickel—Titanium alloys by thermal analysis
YY/T 1771-2021 Standard test method for determination of transformation temperature of nickel-titanium shape memory alloys by bend and free recovery
YS/T 970-2024
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