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GB 4234.9-2023 English PDF

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GB 4234.9-2023: Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
GB 4234.9-2023229 Add to Cart 3 days Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel Valid

Similar standards

GB/T 19701.1   GB/T 19701.2   GB/T 12417.1   GB 4234.3   GB 4234.7   GB 4234.2   

Basic data

Standard ID: GB 4234.9-2023 (GB4234.9-2023)
Description (Translated English): Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
Sector / Industry: National Standard
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 11,132
Date of Issue: 2023-11-27
Date of Implementation: 2025-12-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB 4234.9-2023: Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11:040:40 CCSC35 National Standards of People's Republic of China Surgical implant metal materials Part 9: Forged high nitrogen stainless steel Implantsforsurgery-Metalicmaterials- (ISO 5832-9:2019,MOD) Published on 2023-11-27 Implemented on 2025-12-01 State Administration for Market Regulation Released by the National Standardization Administration Committee

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 Corrosion resistance 3 7 Mechanical properties 3 8 Test method 4 Reference 5

Foreword

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 is Part 9 of GB 4234 "Metal Materials for Surgical Implants": GB 4234 has released the following parts: ---Part 1: Forged stainless steel; ---Part 4: Cast cobalt-chromium-molybdenum alloys; ---Part 9: Forged high-nitrogen stainless steel: This document is modified to adopt ISO 5832-9:2019 "Metallic Materials for Surgical Implants Part 9: Forged High-Nitrogen Stainless Steel": The technical differences between this document and ISO 5832-9:2019 and their reasons are as follows: --- Added to "Scope" "This document is applicable to the testing and evaluation of forged high-nitrogen stainless steel materials for the manufacture of surgical implants:" (See Section 1 chapter); ---Replaced ISO 6892-1 (see Table 6) with GB/T 228:1 to adapt to my country's national conditions; ---Replaced ISO 377 (see 4:1 and 7:1) with GB/T 2975 to adapt to my country's national conditions; ---Replaced ISO 3651-2 (see Table 6) with GB/T 4334-2020 to adapt to my country's national conditions; ---Replaced ISO 4967 (see Table 6) with GB/T 10561-2023 to adapt to my country's national conditions; ---Replaced ISO 404:2013 (see 7:2) with GB/T 17505-2016 to adapt to my country's national conditions; ---Added reference to GB/T 6394 (see Table 6) to adapt to my country's technical conditions and increase operability: 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 and managed by the National Medical Products Administration:

Introduction

Implants are high-risk medical devices, and their material properties are necessary parameters for preclinical evaluation and to ensure the safety of the implant after implantation in the human body: Basic conditions for full validity: The series of standards "Metal Materials for Surgical Implants" aims to standardize the performance requirements and The test method is intended to consist of the following parts: ---Part 1: Forged stainless steel: The purpose is to standardize the performance requirements and test methods for forged 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: Forged titanium-6 aluminum-4 vanadium alloy: The purpose is to standardize the properties of forged titanium-6 aluminum-4 vanadium alloy materials for surgical implants: Energy requirements and test methods: ---Part 4: Cast cobalt-chromium-molybdenum alloys: The purpose is to standardize the performance requirements for cast cobalt-chromium-molybdenum alloy materials for surgical implants: and test methods: ---Part 5: Forged cobalt-chromium-tungsten-nickel alloys: The purpose is to standardize the properties of wrought cobalt-chromium-tungsten-nickel alloy materials for surgical implants: Energy requirements and test methods: ---Part 6: Forged cobalt-nickel-chromium-molybdenum alloys: The purpose is to standardize the properties of wrought cobalt-nickel-chromium-molybdenum alloy materials for surgical implants: Energy requirements and test methods: ---Part 7: Malleable and cold-workable cobalt-chromium-nickel-molybdenum-iron alloys: The purpose is to standardize the use of malleable and cold-worked materials 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 performance requirements of forged high-nitrogen stainless steel materials for surgical implants: experiment method: ---Part 11: Forged titanium-6 aluminum-7 niobium alloy: The purpose is to standardize the quality of forged titanium-6 aluminum-7 niobium alloy materials for surgical implants: Performance requirements and test methods: ---Part 12: Forged cobalt-chromium-molybdenum alloys: The purpose is to standardize the properties of wrought cobalt-chromium-molybdenum alloy materials for surgical implants: Energy requirements and test methods: None of the currently known surgical implant materials has been proven to be completely nontoxic to the human body: However, this document covers The material has demonstrated in long-term clinical use that its expected level of biological response is acceptable if applied appropriately: Surgical implant metal materials Part 9: Forged high nitrogen stainless steel

1 Scope

This document specifies stainless steel with a nitrogen content of 0:25%~0:50% for surgical implants that require high strength and good corrosion resistance: characteristics, and the corresponding test methods are described: This document applies to the testing and evaluation of forged high-nitrogen stainless steel materials for the manufacture of surgical implants: Note: For the requirements for stainless steel for other surgical implants, see GB 4234:1:

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 method (GB/T 228:1-2021, ISO 6892-1: 2019,MOD) GB/T 2975 Sampling locations and sample preparation for mechanical property testing of steel and steel products (GB/T 2975-2018, ISO 377: 2017,MOD) GB/T 4334-2020 Corrosion test method for austenitic and ferritic-austenitic (duplex) stainless steel intergranular corrosion of metals and alloys Law (ISO 3651-1:1998; ISO 3651-2:1998, MOD) GB/T 6394 Determination of average grain size of metals GB/T 10561-2023 Standard rating chart microscopic examination method for determination of non-metallic inclusion content in steel (ISO 4967:2013, MOD) GB/T 17505-2016 General technical requirements for delivery of steel and steel products (ISO 404:2013, MOD) size)

3 Terms and definitions

There are no terms or definitions to be defined in this document:

4 chemical composition

4:1 Sample The selection of samples for chemical analysis should comply with the provisions of GB/T 2975: 4:2 Melting analysis Carry out smelting analysis of steel according to the method specified in Chapter 8, and its chemical composition should comply with the provisions of Table 1:
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