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GB 4234.12-2024: Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
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Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
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GB 4234.12-2024
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Basic data | Standard ID | GB 4234.12-2024 (GB4234.12-2024) | | Description (Translated English) | Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy | | Sector / Industry | National Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,147 | | Date of Issue | 2024-10-28 | | Date of Implementation | 2026-11-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 4234.12-2024: Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
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ICS 11.040.40
CCSC35
National Standard of the People's Republic of China
Surgical implant metal materials
Part 12.Wrought cobalt-chromium-molybdenum alloys
(ISO 5832-12.2019,MOD)
Released on 2024-10-28
2026-11-01 implementation
State Administration for Market Regulation
The National Standardization Administration issued
Table of Contents
Preface III
Introduction IV
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Chemical composition 1
5 Microstructure 2
6 Mechanical properties 2
7 Test method 2
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is part 12 of GB 4234 "Metallic materials for surgical implants". GB 4234 has been published in the following parts.
--- Part 1.Forged stainless steel;
--- Part 2.Pure titanium;
--- Part 3.Wrought titanium-6 aluminium-4 vanadium alloy;
--- Part 4.Cast cobalt-chromium-molybdenum alloys;
--- Part 7.Forgeable and cold worked cobalt-chromium-nickel-molybdenum-iron alloys;
--- Part 9.Forged high nitrogen stainless steel;
--- Part 12.Wrought cobalt-chromium-molybdenum alloys.
This document is modified to adopt ISO 5832-12.2019 "Metallic materials for surgical implants - Part 12.Wrought cobalt-chromium-molybdenum alloys".
The technical differences between this document and ISO 5832-12.2019 and their reasons are as follows.
--- ISO 6892-1 (see Chapter 7) has been replaced by the normative reference GB/T 228.1 to adapt to my country's technical conditions and improve the reliability of the product.
Operability;
--- ISO 643 (see Chapter 7) has been replaced by the normative reference GB/T 6394 to adapt to my country's technical conditions and improve operability.
Acting nature.
The following editorial changes were made to this document.
--- Move "Note 1" in Chapter 1 of ISO 5832-12.2019 to "Note" in Chapter 6.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and coordinated by the State Food and Drug Administration.
Introduction
Implants are high-risk medical devices, and their material properties are essential parameters for preclinical evaluation to ensure the safety of implants after implantation in the human body.
GB 4234 "Metallic Materials for Surgical Implants" series of standards aims to regulate the properties of metallic materials for surgical implants.
The performance requirements and test methods are intended to consist of the following parts.
--- Part 1.Wrought stainless steel. The purpose is to standardize the performance requirements and test methods of wrought stainless steel materials for surgical implants.
--- Part 2.Pure titanium. The purpose is to standardize the performance requirements and test methods of pure titanium materials for surgical implants.
--- Part 3.Wrought titanium-6 aluminum-4 vanadium alloy. The purpose is to standardize the properties of wrought titanium-6 aluminum-4 vanadium alloy materials for surgical implants.
Requirements and test methods.
--- Part 4.Cast cobalt-chromium-molybdenum alloy. The purpose is to specify the performance requirements of cast cobalt-chromium-molybdenum alloy materials for surgical implants
and test methods.
--- Part 5.Wrought cobalt-chromium-tungsten-nickel alloy. The purpose is to standardize the properties of wrought cobalt-chromium-tungsten-nickel alloy materials for surgical implants.
Requirements and test methods.
--- Part 6.Wrought cobalt-nickel-chromium-molybdenum alloy. The purpose is to standardize the properties of wrought cobalt-nickel-chromium-molybdenum alloy materials for surgical implants.
Requirements and test methods.
--- Part 7.Forgeable and cold worked cobalt-chromium-nickel-molybdenum-iron alloys. The purpose is to specify forgeable and cold worked cobalt-chromium-nickel-molybdenum-iron alloys for surgical implants.
Performance requirements and test methods for cobalt-chromium-nickel-molybdenum-iron alloy materials.
--- Part 9.Forged high nitrogen stainless steel. The purpose is to standardize the performance requirements and
Test method.
--- Part 11.Wrought titanium-6 aluminium-7 niobium alloy. The purpose is to specify the wrought titanium-6 aluminium-7 niobium alloy material for surgical implants.
Performance requirements and test methods.
--- Part 12.Wrought cobalt-chromium-molybdenum alloys. The purpose is to specify the performance requirements of wrought cobalt-chromium-molybdenum alloy materials for surgical implants.
Summation test method.
There is no known surgical implant material that has been proven to be completely non-toxic to the human body. However, the materials covered in this document
Long-term clinical applications have shown that if applied appropriately, the expected level of biological response is acceptable.
Surgical implant metal materials
Part 12.Wrought cobalt-chromium-molybdenum alloys
1 Scope
This document specifies the requirements for two wrought Cobalt-28Chromium-6Molybdenum alloys for use in surgical implants.
This document applies to press-worked rods and wires.
Note. High carbon alloys produce a distinct carbide distribution structure that can be adjusted during the production of the bar or during the subsequent heat treatment of the finished product.
The distribution of substances is outside the scope of this document.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 228.1 Tensile tests on metallic materials - Part 1.Test methods at room temperature (GB/T 228.1-2021, ISO 6892-1.
2019,MOD)
GB/T 6394 Determination of average grain size of metals
3 Terms and definitions
There are no terms or definitions that require definition in this document.
The terminology databases used for standardization maintained by ISO and IEC are located at.
4 Chemical composition
Conduct smelting analysis on representative alloy samples according to the method specified in Chapter 7, and their chemical composition shall conform to the requirements of Table 1.
Table 1 Chemical composition
element
Chemical composition
%(mass fraction)
Alloy 1 (low carbon) Alloy 2 (high carbon)
Chromium (Cr) 26.0~30.0 26.0~30.0
Molybdenum (Mo) 5.0~7.0 5.0~7.0
Iron (Fe) ≤0.75 ≤0.75
Manganese (Mn) ≤1.0 ≤1.0
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