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

Publish Date: 2023-12-28 Implement Date: 2025-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 25 Thousand words Pages: 16 pages

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

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