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: PDF in English (GBT 24627-2023)
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 |
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