GB/T 24627-2023 (GB/T24627-2023, GBT 24627-2023, GBT24627-2023) & related versions
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Wrought nickel-titanium shape memory alloys for surgical implants
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GB/T 24627-2023
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GBT 24627-2023
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| GB 24627-2009 | English | 125 |
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Standard specification for wrought Nickel-Titanium shape memory alloys for medical devices and surgical implants
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GB 24627-2009
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GB 24627-2009
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GB/T 24627-2023: Nickel-titanium shape memory alloy processing materials for surgical implants
ICS 11:040:40
CCSC35
National Standards of People's Republic of China
Replace GB 24627-2009
Nickel-titanium shape memory alloy processing materials for surgical implants
Published on 2023-12-28
Implemented on 2025-01-01
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Table of contents
Preface III
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Product Categories 2
5 Ordering information 3
6 Materials and Manufacturing 3
7 chemical composition 3
8 Phase transition temperature 5
9 Organizational Structure 5
10 Mechanical properties 5
11 Special requirements 6
12 Report 6
13 Quality Control Procedure 6
Appendix A (Informative) Principle Explanation 7
Appendix B (informative) Biocompatibility 8
Reference 9
Preface
This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents"
Drafting:
This document replaces GB 24627-2009 "Nickel-titanium shape memory alloy processing materials for medical devices and surgical implants" and is consistent with GB 24627-
Compared with:2009, in addition to structural adjustments and editorial changes, the main technical changes are as follows:
---Changed the scope of application of the standard (see Chapter 1, Chapter 1 of the:2009 edition);
---Added terms and definitions (see Chapter 3);
---Changed the mass fraction requirements for carbon, oxygen, and nitrogen in product chemical composition analysis (see 7:1,:2009 version of 7:1);
---Changed the allowable deviation of the phase transition temperature As (see 8:3,:2009 version of 8:3);
---Added product status requirements for microstructure (see 9:1);
---Added metallurgical micro-cleanliness product status requirements and refined judgment conditions (see 9:2);
---The mechanical property test method has been changed and the tensile test condition requirements have been added (see 10:5,:2009 version of 10:5):
Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:
This document is proposed by the National Medical Products Administration:
This document is under the jurisdiction of the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110):
This document was drafted by: Youyan Medical Devices (Beijing) Co:, Ltd:, Tianjin Medical Device Quality Supervision and Inspection Center, Youyan Yijinxin
Materials Co:, Ltd:, Jiangyin Pell Technology Co:, Ltd:, Xi'an Siwei Intelligent Materials Co:, Ltd:, Shenzhen Institute of Drug Control (Shenzhen Medical
Medical Equipment Testing Center), Lifetech Technology (Shenzhen) Co:, Ltd:, Xi'an Hua Innovation Materials Co:, Ltd:, and Shanghai Shashuo New Materials Co:, Ltd:
The main drafters of this document: Wang Zhenqiang, Zhang Baoxiang, Li Libin, Li Jia, Chen Qingfu, Yang Xiaokang, Yang Han, Hu Junyuan, Niu Zhongjie, Yuan Zhishan,
Wang Jiangbo, Hou Zhichao, Liao Zan, Li Juntao, Zhang Kai, Wen Na, Liu Hongwei, Zhou Xiaoxiao:
The previous versions of this document and the documents it replaces are as follows:
---First published in:2009 as GB 24627-2009;
---This is the first revision:
Nickel-titanium shape memory alloy processing materials for surgical implants
1 Scope
This document specifies nickel-titanium memory alloy rods with a nominal composition (mass fraction) of 54:5% to 57:0% nickel for use in the manufacture of surgical implants:
Chemical, physical, mechanical and metallurgical requirements for materials, plates and tubes:
Note 1: Nickel-titanium memory alloy materials used in the manufacture of other medical devices also refer to this document, and the user evaluates its applicability:
This document applies to rolled products with a diameter or thickness of 5:5mm~94:0mm:
Note 2: Rolled products do not limit the final shape, final surface condition or final performance of the product:
Note 3: For finished cold-processed pipes, refer to YS/T 1136:
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document:
GB/T 228:1 Tensile testing of metallic materials Part 1: Room temperature test methods
GB/T 4698:7 Chemical analysis method for titanium sponge, titanium and titanium alloys - Determination of oxygen and nitrogen content
GB/T 4698:14 Determination of carbon content by chemical analysis method for titanium sponge, titanium and titanium alloys
GB/T 4698:15 Determination of hydrogen content by chemical analysis method of titanium sponge, titanium and titanium alloys
GB/T 6394 Method for determination of average grain size of metals
GB/T 16597 General principles for analysis of metallurgical products by X-ray fluorescence spectrometry
GB/T 18876:1 Standard test for determination of metallographic structure, inclusion content and grade in steel and other metals using automatic image analysis
Methods Part 1: Image Analysis and Stereological Determination of Inclusion or Second Phase Structure Content in Steel and Other Metals
GB/T 23614:1 Methods for chemical analysis of titanium-nickel shape memory alloys Part 1: Determination of nickel content Precipitation and separation of diacetyl oxime
EDTA complex zinc chloride back titration method
YS/T 970 Determination method of phase transformation temperature of nickel-titanium shape memory alloy
YS/T 1064-2015 Nickel titanium shape memory alloy terminology
YY/T 0641 Standard method for measuring phase transformation temperature of NiTi alloys by thermal analysis
YY/T 1771 Bending-free recovery method to test the phase transition temperature of nickel-titanium shape memory alloy
ASTME1409 Test Method for Determination of Oxygen and Nitrogen Content in Titanium and Titanium Alloys by Inert Gas Melting Technique
ASTME1447 Test method for determination of hydrogen content in titanium and titanium alloys by inert gas melt heat conduction method
ASTME1941 Test method for determination of carbon content in refractory and reactive metals and their alloys
3 Terms and definitions
The terms and definitions defined in YS/T 1064-2015 and the following apply to this document:
3:1
ingot
Cast metal used for processing rolled products:
......
GB 24627-2009
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 36
Standard specification for wrought Nickel-Titanium
shape memory alloys for medical devices and surgical
implants
ISSUED ON: NOVEMBER 15, 2009
IMPLEMENTED ON: DECEMBER 01, 2010
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Term ... 5
4 Product classification ... 5
5 Ordering information ... 6
6 Manufacturing ... 6
7 Chemical composition ... 6
8 Phase transition temperature ... 8
9 Metallurgical structure ... 8
10 Mechanical performance requirements ... 9
11 Special requirements ... 10
12 Certificate ... 10
13 Quality control procedure ... 10
14 Keywords ... 10
Appendix A (Informative) Explanation of principles ... 11
Appendix B (Informative) Biocompatibility ... 12
Appendix C (Informative) Mechanical and chemical analysis methods
recommended by national standards ... 14
Standard specification for wrought Nickel-Titanium
shape memory alloys for medical devices and surgical
implants
1 Scope
1.1 This standard specifies the chemical, physical, mechanical and
metallurgical requirements of nickel-titanium memory alloy bars, plates and
tubes which have a nominal composition (mass fraction) of 54.5% ~ 57.0%
nickel for the manufacture of medical devices and surgical implants.
1.2 For rolled products with a diameter or thickness of 6 mm ~ 130 mm, this
standard refers to the requirements under annealing conditions.
1.3 The data in this standard adopts the International System of Units (SI).
2 Normative references
The provisions in following documents become the provisions of this Standard
through reference in this Standard. For the dated references, the subsequent
amendments (excluding corrections) or revisions do not apply to this Standard;
however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
GB/T 6394 Metal - Methods for estimating the average grain size
YY/T 0287 Medical devices - Quality management systems - Requirements
for regulatory purposes (YY/T 0287-2003, ISO 13485:2003, IDT)
YY/T 0641 Standard test method for transformation temperature of nickel -
Titanium alloys by thermal analysis
ASTM E 4 Standard practices for force verification of testing machines
ASTM E 8 Standard test methods for tension testing of metallic materials
ASTM E 1019 Standard test methods for determination of carbon, sulfur,
nitrogen, and oxygen in steel, iron, nickel, and cobalt alloys
ASTM E 1097 Standard guide for direct current plasma emission
5 Ordering information
Inquiries or orders according to this standard shall include the following
information:
a) Quantity: Weight, length or number of pieces;
b) Alloy composition: Expressed in phase transition temperature (see
Chapter 8);
c) Shape: Bar, plate or pipe (see Chapter 4);
d) Status (see 6.3 and 10.1);
e) Mechanical properties: If applicable under special conditions (see Chapter
10);
f) Surface state (see 6.4);
g) Applicable size: Including diameter, thickness, width and length (exact
length, arbitrary length or integer multiples of a given length) or
identification number;
h) Special inspection: Such as chemical analysis of finished rolled products;
i) Special requirements (see Chapter 11).
6 Manufacturing
6.1 The material shall be made of ingots containing nickel and titanium without
other added elements.
6.2 The material shall be smelted in vacuum or inert gas, in order to control the
metallurgical purity and alloy chemical composition.
6.3 Bar, plate and pipe products shall be delivered in hot or cold worked,
annealed or other heat treatment conditions according to the requirements of
the purchase order.
6.4 The surface state can be processed with oxide layer, descaling, pickling,
sandblasting, machining, polishing, mechanical polishing or electrolytic
polishing.
7 Chemical composition
7.1 The chemical composition of the alloy shall meet the requirements of Table
According to the test method of GB/T 6394, the average grain size (G) of the
product shall not be coarser than Grade 4.
9.2 Micro-cleanliness
For all rolled products, the maximum allowable size of loose and non-metallic
inclusions (such as Ti4Ni2Ox and TiC) particles is 39.0 μm. When observing after
magnifying 400 to 500 times, in any field of view, loose and non-metallic
inclusions shall be below 2.8% (area percentage). The evaluation of porosity
and non-metallic inclusions shall be carried out on a cross-section of 6.3 mm ~
94.0 mm in the diameter, thickness, width, height, wall thickness of the rolled
product. The inspection shall be carried out using the method of ASTM E 1245,
or other equivalent methods, on an axial sample parallel to the processing
direction. The supplier and the buyer shall negotiate and determine the number
of samples, sampling location, sample preparation, number of observation
fields, inspection techniques.
10 Mechanical performance requirements
10.1 For the sample taken from the finished product, after annealing, that is,
the material is heated at no less than 800 °C for no less than 15 min, then
treated with a rapid cooling method of water quenching, gas quenching or air
cooling, its mechanical properties shall meet the requirements of Table 3.
Table 3 -- Mechanical properties at annealed state
Diameter or distance between
two parallel surfaces, mm
Tensile strength, Rm
MPa
Elongation, A, measuring length
50 mm or 4 D, %
≤ 50 ≥ 551 ≥ 15
> 50 ≥ 551 ≥ 10
Note: The test environment is 20.0 °C ~ 24.0 °C. 4D refers to 4 times the diameter.
10.2 In order to make the product have a higher ultimate tensile strength and
lower elongation, or other physical and mechanical properties, which are
unanimously recognized by the supplier and the buyer, the material can be
ordered as cold-worked or heat-treated.
10.3 For products with a diameter or thickness greater than 50 mm, they can
be rolled into plates or strips before sampling. For products with a diameter or
thickness less than or equal to 50 mm, samples shall be taken from the product.
10.4 The tensile performance test shall be carried out in the axial direction
consistent with the final processing direction of the sample. The transverse
tensile performance of the wide plate product shall be tested according to the
method negotiated between the user and the supplier.
10.5 Tensile test shall be carried out in accordance with ASTM E 8, using
Appendix A
(Informative)
Explanation of principles
A.1 This standard relates to the chemical, physical, thermomechanical and
metallurgical properties of nickel-titanium alloy processing materials with a
nominal composition (mass fraction) of 54.5% ~ 57.0% nickel for the
manufacture of medical devices and surgical implants.
A.2 The user selects the phase transition temperature and mechanical
properties of the shape memory alloy according to the design and use
requirements of the medical device.
A.3 The thermal-mechanical processing process (especially cold working and
heat treatment) affects the phase transition temperature and other physical and
mechanical properties of the nickel-titanium shape memory alloy. The
annealing state specified in 8.4 and 10.1 only refers to the test sample; the
finished product is usually delivered in the cold working state or the cold working
heat treatment state.
A.4 Thermal mechanical treatment and chemical treatment can affect the
chemical analysis results of the ingot. For example, pickling will cause the
hydrogen content to increase. Therefore, it is required to sample and analyze
the hydrogen content on the finished rolled products (see 7.2).
A.5 The nickel-titanium alloy involved in this standard is usually called nickel-
titanium memory alloy. It is not a single alloy, but a family of alloys marked by
phase transition temperature. The phase transition temperature is measured
under controlled conditions after a prescribed thermomechanical treatment
process.
A.6 The consistency of phase transition temperature refers to the range of As
measured by a certain laboratory in accordance with the test method of YY/T
0641 for a certain component alloy.
A.7 Elements carbon, cobalt, copper, hydrogen, iron, niobium and oxygen are
the residual elements in the alloy (see Table 1). In order to ensure that the shape
memory alloy has good physical and mechanical properties, these residual
elements are controlled within the specified range. The analytical tolerance
range of the product is determined based on the proven analytical capabilities
for the content of these elements.
......
| Standard ID | GB/T 24627-2023 (GB/T24627-2023) | | Description (Translated English) | Wrought nickel-titanium shape memory alloys for surgical implants | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,169 | | Date of Issue | 2023-12-28 | | Date of Implementation | 2025-01-01 | | Older Standard (superseded by this standard) | GB 24627-2009 | | Drafting Organization | Youyan Medical Devices (Beijing) Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, Youyan Yijin New Materials Co., Ltd., Jiangyin Per Technology Co., Ltd., Xi'an Siwei Intelligent Materials Co., Ltd., Shenzhen Institute of Drug Control (Shenzhen Municipal Medical Device Testing Center), Lifetech Technology (Shenzhen) Co., Ltd., Xi'an Hua Innovation Materials Co., Ltd., Shanghai Shashuo New Materials Co., Ltd. | | Administrative Organization | National Technical Committee on Standardization of Surgical Implants and Orthopedic Instruments (SAC/TC 110) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration | | Standard ID | GB 24627-2009 (GB24627-2009) | | Description (Translated English) | Standard specification for wrought Nickel-Titanium shape memory alloys for medical devices and surgical implants | | Sector / Industry | National Standard | | Classification of Chinese Standard | C36 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,125 | | Date of Issue | 2009-11-15 | | Date of Implementation | 2010-12-01 | | Quoted Standard | GB/T 6394; YY/T 0287; YY/T 0641; ASTM E4; ASTM E8; ASTM E1019; ASTM E1097; ASTM E1172; ASTM E1245; ASTM E1409; ASTM E1447; ASTM E1479; ASTM E1941; ASTM F1710; ASTM F2005; ASTM F2082 | | Adopted Standard | ASTM F2063-2005, IDT | | Drafting Organization | Grikin New Material Co., Ltd. | | Administrative Organization | National Surgical implants and orthopedic instruments Standardization Technical Committee | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 13 of 2009 (No. 153 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | | Summary | This Chinese standard relates to manufacture of medical devices and surgical implants, nominal composition (mass fraction) was 54. 5 % ~ 57. 0% Nickel nickel titanium shape memory alloy rods, plates and tubes of chemical, physical, mechanical, and metallurgical requirements. The diameter or thickness of 6 mm ~ 130 mm of the rolled product, the standard refers to the requirements of the annealed condition. The data used in this standard International System of Units (SI). |
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