GB/T 24627-2023 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB/T 24627-2023 | English | 230 |
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Wrought nickel-titanium shape memory alloys for surgical implants
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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/T 24627-2023: Wrought nickel-titanium shape memory alloys for surgical implants---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT24627-2023
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
CCS C 35
Replacing GB 24627-2009
Wrought Nickel-Titanium Shape Memory Alloys for
Surgical Implants
Issued on: DECEMBER 28, 2023
Implemented on: JANUARY 1, 2025
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 6
4 Classification of Product... 7
5 Ordering Information... 8
6 Materials and Manufacturing... 8
7 Chemical Compositions... 9
8 Phase-Change Temperature... 10
9 Structure... 11
10 Mechanical Properties... 12
11 Special Requirements... 13
12 Report... 13
13 Quality Control Procedures... 13
Appendix A (Informative) Principles... 14
Appendix B (Informative) Biocompatibility... 15
Bibliography... 16
Wrought Nickel-Titanium Shape Memory Alloys for
Surgical Implants
1 Scope
This Document specifies the chemical, physical, mechanical and metallurgical requirements for
nickel-titanium memory alloy rods, sheets and tubes with a nominal composition (mass fraction)
of 54.5%~57.0% nickel for the manufacture of surgical implants.
NOTE 1.Nickel-titanium memory alloy materials used to manufacture other medical devices also refer
to this Document, and the user shall evaluate its applicability.
This Document applies to mill products with a diameter or thickness of 5.5mm~94.0mm.
NOTE 2.Mill products do not limit the final shape, final surface state or final performance of the product.
NOTE 3.Cold-worked tube finished products refer to YS/T 1136.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in this Document. For the dated documents, only the versions with the dates
indicated are applicable to this Document; for the undated documents, only the latest version
(including all the amendments) is applicable to this Document.
GB/T 228.1 Metallic materials – Tensile testing – Part 1.Method of test at room
temperature
GB/T 4698.7 Methods for chemical analysis of titanium sponge, titanium and titanium
alloys -Determination of oxygen and nitrogen content
GB/T 4698.14 Methods for chemical analysis of titanium sponge, titanium and titanium
alloys - Determination of carbon content
GB/T 4698.15 Methods for chemical analysis of titanium sponge, titanium and titanium
alloys - Determination of hydrogen content
GB/T 6394 Metal - Methods for estimating the average grain size
GB/T 16597 Analytical methods of metallurgical products - General rule for X-ray
fluorescence spectrometric methods
GB/T 18876.1 Standard practice for determining the metallographic 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 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 Phase change temperature measuring method for nickel-titanium shape memory
alloys
YS/T 1064-2015 Terminology for nickel-titanium shape memory alloys
YY/T 0641 Standard test method for transformation temperature of nickel-titanium alloys
by thermal analysis
YY/T 1771 Standard test method for determination of transformation temperature of
nickel-titanium shape memory alloys by bend and free recovery
ASTM E1409 Standard Test Method for Determination of Oxygen and Nitrogen in
Titanium and Titanium Alloys by Inert Gas Fusion
ASTM E1447 Standard Test Method for Determination of Hydrogen in Titanium and
Titanium Alloys by the Inert Gas Fusion Thermal Conductivity Method
ASTM E1941 Standard Test Method for Determination of Carbon in Refractory and
Reactive Metals and Their Alloys
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in YS/T 1064-2015 and the
following apply.
3.1 Ingot
Cast metal that is used for processing into mill product.
3.2 Mill product
The mill semi-finished or finished products.
NOTE. It is a bar, wire or coil. Product states include hot-processed, hot-processed and cold-formed, hot-
processed and cold-processed, hot-processed and annealed, and cold-processed and annealed products.
3.3 Martensite start temperature; Ms
The start temperature of the transformation from the parent phase to the martensite phase during
the one-step phase-change cooling process, or the start temperature of the transformation from
the R-phase (transition phase) to the martensite phase during the two-step phase-change cooling
process.
[SOURCE. YS/T 1064-2015, 3.7, modified]
3.4 Martensite peak temperature; Mp
The temperature at which the parent phase transforms to the martensite phase at the maximum
exothermic peak on the one-step phase-change differential scanning calorimetry cooling curve,
or the temperature at which the R-phase transforms to the martensite phase at the maximum
exothermic peak on the two-step phase-change differential scanning calorimetry exothermic
curve.
[SOURCE. YS/T 1064-2015, 3.8, modified]
3.5 Martensite finish temperature; Mf
The final temperature of the transformation from the parent phase to the martensite phase during
the one-step phase-change cooling process, or the completion temperature of the transformation
from the R-phase to the martensite phase during the two-step phase-change cooling process.
3.6 Austenite start temperature; As
The start temperature of the transformation from martensite phase to austenite phase in a one-
step phase-change heating process, or the start temperature of the transformation from R-phase
to austenite phase in a two-step phase-change heating process.
3.7 Austenite peak temperature; Ap
The temperature at which the martensite phase transforms to the austenite phase corresponding
to the maximum value of the endothermic peak on the one-step phase-change differential
scanning calorimetry heating curve, or the temperature at which the R-phase transforms to the
austenite phase corresponding to the maximum value of the endothermic peak on the two-step
phase-change differential scanning calorimetry heating curve.
3.8 Austenite finish temperature; Af
The final temperature of the transformation from martensite phase to austenite phase in a one-
step phase-change heating process, or the completion temperature of the transformation from
R-phase to austenite phase in a two-step phase-change heating process.
4 Classification of Product
4.1 Bars
grinding, mechanical polishing or electrolytic polishing.
NOTE. The material principle and biocompatibility involved in this Document are described in Annexes
A and B.
7 Chemical Compositions
7.1 Requirements
The chemical compositions of the ingot shall meet the requirements of Table 1.Except for
hydrogen, the elements in Table 1 can be sampled and analyzed from the ingot. Hydrogen shall
be sampled and analyzed from the final product (see Clause 4) or in a manner agreed upon by
the supplier and the purchaser. The supplier shall not ship if the chemical composition exceeds
the range given in Table 1.
The purpose of product analysis is to verify the chemical compositions of the ingot, the
processing batch, and determine the variation of the chemical composition within the ingot.
Based on the product analysis, the purchaser decides whether to accept the ingot or the batch
of processed materials.
The requirements for the content of main compositions and impurity elements are shown in
Table 1.
7.2 Analysis methods
The main components shall be analyzed according to the method specified in GB/T 23614.1,
X-ray spectrometry specified in GB/T 16597, inductively coupled plasma atomic emission
spectrometry or equivalent methods; the carbon content shall be determined according to the
method specified in GB/T 4698.14 and ASTM E1941; the hydrogen content shall be determined
according to the method specified in GB/T 4698.15 or the inert gas fusion method or vacuum
extraction method specified in ASTM E1447; the oxygen and nitrogen contents shall be
determined according to the method specified in GB/T 4698.7 or the inert gas fusion method
specified in ASTM E1409; the contents of cobalt, copper, chromium, iron, niobium, etc. shall
be analyzed according to inductively coupled plasma atomic emission spectrometry or
equivalent methods. The titanium content is determined by the difference-method and does not
require analysis.
a standard-length sample suitable for the size of the product to be tested; the tensile strain rate
is between (0.003~0.1)/min; and for annealed samples, the tensile temperature is 5℃~10℃
higher than Af. The tensile properties shall meet the requirements of Table 4.
10.6 Other special mechanical property tests shall be specified in the order form.
11 Special Requirements
11.1 Dimensional tolerances and ovality tolerances shall be specified in the order form.
11.2 Special phase-change temperature requirements due to product shape, sampling location
or heat treatment shall be specified in the order form.
11.3 Surface roughness shall be specified in the order form.
12 Report
The supplier shall provide a report on the manufacture and inspection of the material in
accordance with this Document at the time of shipment. The report shall include the
manufacturing, inspection, sampling and test methods consistent with this Document. The
report shall include the summary of chemical composition, phase-change temperature, structure,
description of structure analysis and mechanical property test results agreed upon by the
purchaser and the supplier (see Clause 7 to 10). The report includes the sampling material size,
location, condition and test method. For metallurgical micro cleanliness, the report shall include
the sampled product size, product sampling quantity and location, relationship between field of
view direction and processing direction, sample preparation, field of view quantity and
measurement method. The report shall include the melting ingot method and processing method
(including hot rolling, forging, extrusion or cold processing) agreed upon by the supplier and
the purchaser.
13 Quality Control Procedures
The supplier shall maintain certain quality control procedures, such as meeting the requirements
of GB/T 42061.
Appendix A
(Informative)
Principles
A.1 The user selects the phase-change temperature and mechanical properties of the shape
memory alloy according to the design and use requirements of the product.
A.2 Thermo-mechanical processing (especially cold processing and heat treatment) affects the
phase-change temperature and other physical and mechanical properties of nickel-titanium
shape memory alloy. The annealing state specified in 8.4 and 10.1 refers only to test samples,
and the finished products are usually delivered in cold processing state or cold processing and
heat-treating state.
A.3 Thermo-mechanical treatment and chemical treatment can affect the chemical analysis
results of the ingot. For example, pickling shall lead to an increase in hydrogen content.
Therefore, it is specified to sample and analyze the hydrogen content on the final rolled product
(see 7.1).
A.4 The nickel-titanium alloy involved in this Document is usually called "nickel-titanium
memory alloy". It is not a single alloy, but a family of alloys marked with a phase-change
temperature, which is measured under controlled conditions after the specified thermo-
mechanical treatment process.
A.5 Phase-change temperature consistency refers to the As range measured by a laboratory for
a certain composition alloy according to the test method of YY/T 0641.
A.6 Elements carbon, cobalt, copper, hydrogen, iron, niobium and oxygen are 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
analysis tolerance range of the product is determined based on the proven analytical capability
of the content of these elements.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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