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Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)
外科植入物 - 金属材料 - 第 1 部分：锻造不锈钢 （ISO 5832-1：2024）

Implants chirurgicaux - Matériaux métalliques - Partie
种植体 chirurgicaux - Matériaux métalliques - Partie
Chirurgische Implantate - Metallische Werkstoffe - Teil 1: Acier inoxydable corroyé (ISO 5832-1:2024)
Chirurgische 植入物 - Metallische Werkstoffe - Teil 1：Acier 无氧腐蚀 （ISO 5832-1：2024）
This European Standard was approved by CEN on 23 June 2023.
该欧洲标准于 2023 年 6 月 23 日获得 CEN 批准。
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
CEN 成员必须遵守 CEN/CENELEC 内部法规，该法规规定了赋予本欧洲标准国家标准地位的条件，不得进行任何更改。有关此类国家标准的最新列表和参考书目可在向 CEN-CENELEC 管理中心或任何 CEN 成员申请时获得。
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
该欧洲标准有三个正式版本（英语、法语、德语）。由 CEN 成员负责将任何其他语言翻译成其自己的语言并通知 CEN-CENELEC 管理中心的版本与正式版本具有相同的地位。
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.
CEN 成员是奥地利、比利时、保加利亚、克罗地亚、塞浦路斯、捷克共和国、丹麦、爱沙尼亚、芬兰、法国、德国、希腊、匈牙利、冰岛、爱尔兰、意大利、拉脱维亚、立陶宛、卢森堡、马耳他、荷兰、挪威、波兰、葡萄牙、北马其顿共和国、罗马尼亚、塞尔维亚、斯洛伐克、斯洛文尼亚、西班牙、瑞典、瑞士、土耳其和英国的国家标准机构。
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
CEN-CENELEC 管理中心：Rue de la Science 23， B-1040 Brussels
EN ISO 5832-1:2024 (E) EN ISO 5832-1：2024 （E） 标准）
Contents Page 目录页面
European foreword … 3 欧洲前言 ...3

European foreword 欧洲前言

This document (EN ISO 5832-1:2024) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN.
本文件 （EN ISO 5832-1：2024） 由 ISO/TC 150“外科植入物”技术委员会与 CEN/TC 285“非有源外科植入物”技术委员会合作编写，其秘书处由 DIN 担任。
This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2024, and conflicting national standards shall be withdrawn at the latest by October 2024.
本欧洲标准最迟应在 2024 年 10 月之前通过发布相同的文本或通过认可获得国家标准的地位，并且冲突的国家标准最迟应在 2024 年 10 月之前撤回。
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
请注意，本文档的某些元素可能成为专利权的主题。CEN 不负责识别任何或所有此类专利权。
This document supersedes EN ISO 5832-1:2019.
本文件取代 EN ISO 5832-1：2019。
Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN website.
有关本文档的任何反馈和问题应直接提交给用户的国家标准机构/国家委员会。这些机构的完整列表可以在 CEN 网站上找到。
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.
根据 CEN-CENELEC 内部法规，以下国家/地区的国家标准组织必须实施此欧洲标准：奥地利、比利时、保加利亚、克罗地亚、塞浦路斯、捷克共和国、丹麦、爱沙尼亚、芬兰、法国、德国、希腊、匈牙利、冰岛、爱尔兰、意大利、拉脱维亚、立陶宛、卢森堡、马耳他、荷兰、挪威、波兰、葡萄牙、北马其顿共和国、罗马尼亚、塞尔维亚、斯洛伐克、斯洛文尼亚、西班牙、瑞典、 瑞士、土耳其和英国。

Endorsement notice 签注通知

The text of ISO 5832-1:2024 has been approved by CEN as EN ISO 5832-1:2024 without any modification.
ISO 5832-1：2024 的文本已被 CEN 批准为 EN ISO 5832-1：2024，无需任何修改。

International Standard 国际标准

ISO 5832-1 ISO 5832-1 标准

Implants for surgery - Metallic materials -
外科植入物 - 金属材料 -

Sixth edition 2024-04 第六版 2024-04

Part 1:
Wrought stainless steel
第 1 部分： 锻造不锈钢

Implants chirurgicaux - Matériaux métalliques -
种植体 chirurgicaux - Matériaux métalliques -
Partie 1: Acier inoxydable corroyé
第 1 部分：Acier inoxydable corroyé
© ISO 2024 © ISO 2024 认证
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of the requester.
保留所有权利。除非另有规定或在其实施过程中要求，否则未经事先书面许可，不得以任何形式或任何电子或机械方式（包括影印）复制或以其他方式使用本出版物的任何部分，或在互联网或内联网上发布。可以向以下地址的 ISO 或请求者所在国家/地区的 ISO 成员机构请求许可。
ISO copyright office ISO 版权局
CP 401 - Ch. de Blandonnet 8
CH-1214 Vernier, Geneva CH-1214 Vernier， 日内瓦
Phone: +41 227490111 电话： +41 227490111
Email: copyright@iso.org
电子邮件： copyright@iso.org
Website: www.iso.org
网站： www.iso.org
Published in Switzerland 出版地：瑞士
Contents Page 目录页面
Foreword … iv 前言。。。四
Introduction … v 介绍。。。v
1 Scope … 1 1 范围 ...1
2 Normative references … 1
2 规范性参考 ...1
3 Terms and definitions … 1
3 术语和定义 ...1
4 Chemical composition … 2
4 化学成分 ...2
4.1 Test samples … 2
4.1 测试样品 ...2
4.2 Cast analysis. … 2
4.2 演员分析。…2
5 Microstructure in the fully annealed condition … 2
5 完全退火状态下的微观结构 ...2
5.1 Grain size … 2
5.1 粒度 ...2
5.2 Microstructure … 3 5.2 微观结构3
5.3 Inclusion content … 3
5.3 包含内容 ...3
6 Mechanical properties … 3
6 机械性能 ...3
6.1 Test pieces … 3
6.1 试件 ...3
6.2 Tensile test … 3
6.2 拉伸试验3
6.3 Gauge length … 3
6.3 标距长度 ...3
7 Test methods … 3
7 测试方法 ...3
Bibliography … 6 书目。。。6

ISO 5832-1:2024(en) ISO 5832-1：2024（英文）

Foreword 前言

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
ISO（国际标准化组织）是国家标准机构（ISO 成员机构）的全球联合会。国际标准的编制工作通常由 ISO 技术委员会进行。对已成立技术委员会的主题感兴趣的每个成员机构都有权在该委员会中派代表。与 ISO 联络的政府和非政府组织也参与了这项工作。ISO 与国际电工委员会 （IEC） 在电工标准化的所有事务上密切合作。
The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO/IEC 指令第 1 部分介绍了用于编写本文档的程序以及用于进一步维护本文档的程序。特别是，应注意不同类型的 ISO 文件所需的不同批准标准。本文件是根据 ISO/IEC 指令第 2 部分的编辑规则起草的（参见 www.iso.org/directives）。
ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 提请注意，本文件的实施可能涉及使用 （a） 专利。ISO 对任何声称的专利权的证据、有效性或适用性不持任何立场。截至本文档发布之日，ISO 尚未收到 （a） 实施本文档可能需要的专利的通知。但是，实施者应注意，这可能不代表最新信息，这些信息可以从 www.iso.org/patents 提供的专利数据库中获得。ISO 不负责识别任何或所有此类专利权。
Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.
本文档中使用的任何商号均为为方便用户而提供的信息，不构成认可。
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
有关标准的自愿性、与合格评定相关的 ISO 特定术语和表达的含义，以及有关 ISO 在贸易技术壁垒 （TBT） 中遵守世界贸易组织 （WTO） 原则的信息，请参见 www.iso.org/iso/foreword.html。
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
本文件由 ISO/TC 150 外科植入物技术委员会、SC 1 小组委员会材料与欧洲标准化委员会 （CEN） 技术委员会 CEN/TC 285 非有源外科植入物合作编写，根据 ISO 和 CEN 之间的技术合作协议（维也纳协定）。
This sixth edition cancels and replaces the fifth edition (ISO 5832-1:2016), which has been technically revised.
第六版取消并取代了第五版 （ISO 5832-1：2016），后者已经过技术修订。
The main changes are as follows:
主要变化如下：
  • the introduction has been updated;
    引言已更新;
  • normative references have been updated;
    规范性参考文献已更新;
  • the requirement for silicon in Table 1 has been changed to 0,75 max;
    表 1 中对硅的要求已更改为最大 0,75;
  • the requirement for cobalt in Table 1 has been added;
    增加了表 1 中对钴的要求;
  • requirements for mechanical properties in Table 4 have been updated;
    更新了表 4 中的机械性能要求;
  • this document has been harmonized with the ISO 5832 series.
    本文件已与 ISO 5832 系列协调一致。
A list of all parts in the ISO 5832 series can be found on the ISO website.
ISO 5832 系列中所有零件的列表可以在 ISO 网站上找到。
Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.
有关本文档的任何反馈或问题应直接提交给用户的国家标准机构。这些尸体的完整列表可以在 www.iso.org/members.html 上找到。

Introduction 介绍

While no known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body, long-term clinical experience with the material referred to in this document has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications. However, this document covers the raw material and not finished medical devices, where the design and fabrication of the device can impact biological response.
虽然从未证明任何已知的外科植入物材料绝对不会对人体造成不良反应，但对本文件中提到的材料的长期临床经验表明，当该材料用于适当的应用时，可以预期可接受的生物反应水平。但是，本文件涵盖原材料而不是成品医疗器械，在这些过程中，设备的设计和制造可能会影响生物反应。

Implants for surgery — Metallic materials -
外科植入物 — 金属材料 -

Part 1: 第 1 部分：

Wrought stainless steel 锻造不锈钢

1 Scope 1 范围

This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
本文件规定了用于制造外科植入物的锻造不锈钢的特性和相应的测试方法。
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
注 1 从由这种合金制成的成品中获得的样品的机械性能可能与本文件中规定的不同。
NOTE 2 The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.
注 2 本文件中描述的合金对应于 ASTM F138 和 ASTM F139 中的 UNS S31673。

2 Normative references 2 规范性参考

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
以下文档在文本中的引用方式使其部分或全部内容构成本文档的要求。对于注明日期的参考文献，仅引用的版本适用。对于未注明日期的参考文献，适用参考文件的最新版本（包括任何修订）。
ISO 377, Steel and steel products — Location and preparation of samples and test pieces for mechanical testing
ISO 377，钢铁和钢铁产品 - 用于机械测试的样品和试件的位置和制备
ISO 404, Steel and steel products — General technical delivery requirements
ISO 404，钢铁和钢铁产品 — 一般技术交付要求
ISO 439, Steel and cast iron — Determination of silicon content — Gravimetric method
ISO 439，钢和铸铁 - 硅含量的测定 - 重量法
ISO 629, Steel and cast iron — Determination of manganese content — Spectrophotometric method
ISO 629，钢和铸铁 — 锰含量的测定 — 分光光度法
ISO 643, Steels - Micrographic determination of the apparent grain size
ISO 643，钢 - 表观晶粒尺寸的显微测定
ISO 671, Steel and cast iron — Determination of sulphur content — Combustion titrimetric method
ISO 671，钢和铸铁 - 硫含量的测定 - 燃烧滴定法
ISO 4967:2013, Steel - Determination of content of non-metallic inclusions - Micrographic method using standard diagrams
ISO 4967：2013，钢 - 非金属夹杂物含量的测定 - 使用标准图的显微照相法
ISO 6892-1:2019, Metallic materials — Tensile testing — Part 1: Method of test at room temperature
ISO 6892-1：2019，金属材料 - 拉伸试验 - 第 1 部分：室温试验方法
ISO 10714, Steel and iron - Determination of phosphorus content - Phosphovanadomolybdate spectrophotometric method
ISO 10714，钢和铁 - 磷含量的测定 - 磷酸钒钼酸盐分光光度法

3 Terms and definitions 3 术语和定义

For the purposes of this document, the terms and definitions given in ISO 6892-1 and the following apply. ISO and IEC maintain terminology databases for use in standardization at the following addresses:
就本文档而言，ISO 6892-1 和以下内容中给出的术语和定义适用。ISO 和 IEC 在以下地址维护用于标准化的术语数据库：

ISO 5832-1:2024(en) ISO 5832-1：2024（英文）

3.1

original gauge length 原始标距长度

L 0 L 0 L_(0)L_{0}
length between gauge length marks on the test piece measured at room temperature before the test
测试前在室温下测量的试件上的标距长度标记之间的长度
[SOURCE: ISO 6892-1:2019, 3.1.1, modified — Note 1 to entry has been deleted.]
[来源：ISO 6892-1：2019,3.1.1，修改 — 条目的注释 1 已删除。

4 Chemical composition 4 化学成分

4.1 Test samples 4.1 测试样本

The selection of samples for analysis shall be carried out in accordance with ISO 377.
应根据 ISO 377 选择用于分析的样品。

4.2 Cast analysis 4.2 演员分析

The cast analysis of the steel when determined in accordance with Clause 7 shall conform to the chemical composition specified in Table 1. The molybdenum and chromium contents shall be such that the C C CC value obtained from Formula (1) is not less than 26.
根据第 7 条确定钢的铸造分析应符合表 1 中规定的化学成分。钼和铬的含量应使从公式 （1） 得到 C C CC 的值不小于 26。
C = 3 , 3 w Mo + w Cr C = 3 , 3 w Mo + w Cr C=3,3w_(Mo)+w_(Cr)C=3,3 w_{\mathrm{Mo}}+w_{\mathrm{Cr}}
where 哪里
w Mo w Mo  w_("Mo ")w_{\text {Mo }} is the mass fraction of molybdenum, expressed as a percentage;
w Mo w Mo  w_("Mo ")w_{\text {Mo }} 是钼的质量分数，以百分比表示;
w Cr w Cr w_(Cr)w_{\mathrm{Cr}} is the mass fraction of chromium content, expressed as a percentage.
w Cr w Cr w_(Cr)w_{\mathrm{Cr}} 是铬含量的质量分数，以百分比表示。
Table 1 - Chemical composition
表 1 - 化学成分
Element 元素

成分限 % % %\% 值的质量分数
Mass fraction of compositional limits
% % %\%
Mass fraction of compositional limits %| Mass fraction of compositional limits | | :---: | | $\%$ |
Carbon 碳 0,030 max. 最大 0,030
Silicon 硅 0,75 max. a a ^(a){ }^{a} 最大 a a ^(a){ }^{a} 0,75
Manganese 锰 2,0 max. 最大 2,0
Phosphorus 磷 0,025 max. 最大 0,025
Sulfur 硫 0,010 max. 最大 0,010
Nitrogen 氮 0,10 max. 最大 0,10
Chromium 铬 17,0 to 19,0 max. 最大 17,0 至 19,0
Molybdenum 钼 2,25 to 3,00 2,25 至 3,00
Nickel 镍 13,0 to 15,0 13,0 至 15,0
Copper 铜 0,50 max. 最大 0,50
Cobalt 钴 < 0 , 10 a < 0 , 10 a < 0,10^(a)<0,10^{a}
Iron 铁 Balance 平衡

a 根据 ASTM F138 和 ASTM F139 调整的值。经 ASTM F138 许可转载，版权所有 ASTM International。完整标准的副本可从 www.astm org 获得。
a
Values adjusted to ASTM F138 and ASTM F139. Reprinted with permission from ASTM F138,
copyright ASTM International. A copy of the complete standard may be obtained from www.astm
org.
a Values adjusted to ASTM F138 and ASTM F139. Reprinted with permission from ASTM F138, copyright ASTM International. A copy of the complete standard may be obtained from www.astm org.| a | | :--- | | Values adjusted to ASTM F138 and ASTM F139. Reprinted with permission from ASTM F138, | | copyright ASTM International. A copy of the complete standard may be obtained from www.astm | | org. |
Element "Mass fraction of compositional limits %" Carbon 0,030 max. Silicon 0,75 max. ^(a) Manganese 2,0 max. Phosphorus 0,025 max. Sulfur 0,010 max. Nitrogen 0,10 max. Chromium 17,0 to 19,0 max. Molybdenum 2,25 to 3,00 Nickel 13,0 to 15,0 Copper 0,50 max. Cobalt < 0,10^(a) Iron Balance "a Values adjusted to ASTM F138 and ASTM F139. Reprinted with permission from ASTM F138, copyright ASTM International. A copy of the complete standard may be obtained from www.astm org." | Element | Mass fraction of compositional limits <br> $\%$ | | :---: | :---: | | Carbon | 0,030 max. | | Silicon | 0,75 max. ${ }^{a}$ | | Manganese | 2,0 max. | | Phosphorus | 0,025 max. | | Sulfur | 0,010 max. | | Nitrogen | 0,10 max. | | Chromium | 17,0 to 19,0 max. | | Molybdenum | 2,25 to 3,00 | | Nickel | 13,0 to 15,0 | | Copper | 0,50 max. | | Cobalt | $<0,10^{a}$ | | Iron | Balance | | a <br> Values adjusted to ASTM F138 and ASTM F139. Reprinted with permission from ASTM F138, <br> copyright ASTM International. A copy of the complete standard may be obtained from www.astm <br> org. | |

5 Microstructure in the fully annealed condition
5 完全退火状态下的微观结构

5.1 Grain size 5.1 粒度

The austenitic grain size, determined in accordance with Clause 7, shall not be coarser than grain size No. 5 .
根据第 7 条确定的奥氏体晶粒尺寸不应比 5 号晶粒粗。

ISO 5832-1:2024(en) ISO 5832-1：2024（英文）

5.2 Microstructure 5.2 微观结构

The steel shall have a structure free from delta ferrite, chi or sigma phase, when examined in accordance with Clause 7.
根据第 7 条进行检查时，钢材应具有不含 δ 铁素体、chi 或 sigma 相的结构。

5.3 Inclusion content 5.3 包含内容

The non-metallic inclusion content of the steel, determined at finished size after a hot-rolling process stage and in accordance with Clause 7 , shall not exceed the limits given in Table 2.
根据第 7 条，在热轧工艺阶段后按成品尺寸确定的钢的非金属夹杂物含量不得超过表 2 中给出的限值。
NOTE It can be necessary to use vacuum or electroslag melting to produce a steel conforming with these cleanliness requirements.
注意 可能需要使用真空或电渣熔炼来生产符合这些清洁度要求的钢。
Table 2 - Inclusion content limits
表 2 - 包含内容限制
Type of inclusion 内含物类型 Inclusion content reference number
内含物内容参考编号
thin 薄 thick 厚
A - Sulfides A - 硫化物 1,5 1
B - Aluminates B - 铝酸盐 1,5 1
C - Silicates C - 硅酸盐 1,5 1
D - Oxides, globular D - 氧化物，球状的 1,5 1
Type of inclusion Inclusion content reference number thin thick A - Sulfides 1,5 1 B - Aluminates 1,5 1 C - Silicates 1,5 1 D - Oxides, globular 1,5 1| Type of inclusion | Inclusion content reference number | | | :---: | :---: | :---: | | | thin | thick | | A - Sulfides | 1,5 | 1 | | B - Aluminates | 1,5 | 1 | | C - Silicates | 1,5 | 1 | | D - Oxides, globular | 1,5 | 1 |

6 Mechanical properties 6 机械性能

6.1 Test pieces 6.1 试片

The selection and preparation of samples and test pieces for tensile testing shall be in accordance with ISO 377.
用于拉伸试验的样品和试件的选择和制备应符合 ISO 377。

6.2 Tensile test 6.2 拉伸试验

The tensile properties of the steel in the form of bars, wires, and sheet and strip, when tested in accordance with Clause 7 ―  Clause  7 _ " Clause "7_\underline{\text { Clause } 7}, shall conform to the values specified in Tables 3 , 4 ― 3 , 4 _ 3,4_3, \underline{4} and 5 ― 5 _ 5_\underline{5}, respectively.
按照 Clause 7 ―  Clause  7 _ " Clause "7_\underline{\text { Clause } 7} 进行测试时，棒材、线材、板材和带材形式的钢材的拉伸性能应分别符合表 3 , 4 ― 3 , 4 _ 3,4_3, \underline{4} 和 5 ― 5 _ 5_\underline{5} 中规定的值。
If any of the test pieces do not meet the specified requirements or break outside the gauge limits, retests shall be carried out in accordance with ISO 404.
如果任何试件不符合规定要求或超出标距限制，则应根据 ISO 404 进行重新测试。

6.3 Gauge length 6.3 标距长度

Original gauge length, L 0 L 0 L_(0)L_{0}, shall be either 5 , 65 × S 0 5 , 65 × S 0 5,65 xxsqrt(S_(0))5,65 \times \sqrt{S_{0}} or 50 mm , where S 0 S 0 S_(0)S_{0} is defined as the original crosssectional area in square millimetres. The gauge length chosen for testing shall be reported with the test results.
原始标距长度 L 0 L 0 L_(0)L_{0} 应为 5 , 65 × S 0 5 , 65 × S 0 5,65 xxsqrt(S_(0))5,65 \times \sqrt{S_{0}} 或 50 毫米 ，其中 S 0 S 0 S_(0)S_{0} 定义为以平方毫米为单位的原始横截面积。选择用于测试的标距长度应与测试结果一起报告。

7 Test methods 7 测试方法

The test methods to be used in determining conformity with the requirements of this document shall be those given in Table 6.
用于确定是否符合本文件要求的测试方法应为表 6 中给出的测试方法。
Table 3 - Mechanical properties of bars
表 3 - 棒材的机械性能
Condition 条件

直径或厚度 d d dd
Diameter or
thickness
d d dd
Diameter or thickness d| Diameter or | | :---: | | thickness | | $d$ |

抗张强度 R m R m R_(m)R_{\mathrm{m}}
Tensile
strength
R m R m R_(m)R_{\mathrm{m}}
Tensile strength R_(m)| Tensile | | :---: | | strength | | $R_{\mathrm{m}}$ |

最小验证强度或屈服强度 R p 0 , 2 , min R p 0 , 2 , min R_(p0,2,min)R_{\mathrm{p} 0,2, \min }
Minimum proof strength or
yield strength
R p 0 , 2 , min R p 0 , 2 , min R_(p0,2,min)R_{\mathrm{p} 0,2, \min }
Minimum proof strength or yield strength R_(p0,2,min)| Minimum proof strength or | | :---: | | yield strength | | $R_{\mathrm{p} 0,2, \min }$ |

骨折后的最小伸长率
Minimum percentage
elongation after fracture
Minimum percentage elongation after fracture| Minimum percentage | | :---: | | elongation after fracture |
mm 毫米 MPa 兆帕 A min A min A_(min)A_{\min }
% % %\%
Condition "Diameter or thickness d" "Tensile strength R_(m)" "Minimum proof strength or yield strength R_(p0,2,min)" "Minimum percentage elongation after fracture" mm MPa A_(min) % | Condition | Diameter or <br> thickness <br> $d$ | Tensile <br> strength <br> $R_{\mathrm{m}}$ | Minimum proof strength or <br> yield strength <br> $R_{\mathrm{p} 0,2, \min }$ | Minimum percentage <br> elongation after fracture | | :---: | :---: | :---: | :---: | :---: | | | mm | MPa | $A_{\min }$ | | | $\%$ | | | | |
Table 4-Mechanical properties of wires
表 4 - 电线的机械性能
Condition 条件

直径 d mm
Diameter
d
mm
Diameter d mm| Diameter | | :--- | | d | | mm |

拉伸强度 R m R m R_(m)R_{\mathrm{m}} MPa
Tensile strength
R m R m R_(m)R_{\mathrm{m}}
MPa
Tensile strength R_(m) MPa| Tensile strength | | :--- | | $R_{\mathrm{m}}$ | | MPa |

骨折后的最小伸长率
Minimum percentage
elongation after fracture
A min A min A_(min)A_{\min }
% % %\%
A_(min) %| $A_{\min }$ | | :---: | | $\%$ |
一个 分钟 一个 分钟 A_（min）A_{\min }
% %%\%
A_（分钟） %|$A_{\min }$ | |:---: | |$\%$ |
Minimum percentage elongation after fracture A_(min),%| Minimum percentage | | :--- | | elongation after fracture | | $A_{\min }$ <br> $\%$ |
Annealed 退火 0 , 025 ≤ d ≤ 0 , 13 0 , 025 ≤ d ≤ 0 , 13 0,025 <= d <= 0,130,025 \leq d \leq 0,13 490 ≤ R m ≤ 1000 b 490 ≤ R m ≤ 1000 b 490 <= R_(m) <= 1000^(b)490 \leq R_{\mathrm{m}} \leq 1000^{\mathrm{b}} 30 0 , 13 < d ≤ 0 , 23 0 , 13 < d ≤ 0 , 23 0,13 < d <= 0,230,13<d \leq 0,23 ≤ 930 ≤ 930 <= 930\leq 930 30 0 , 38 < d ≤ 0 , 5 0 , 38 < d ≤ 0 , 5 0,38 < d <= 0,50,38<d \leq 0,5 ≤ 860 ≤ 860 <= 860\leq 860 40 0 , 5 < d ≤ 0 , 65 0 , 5 < d ≤ 0 , 65 0,5 < d <= 0,650,5<d \leq 0,65 ≤ 820 ≤ 820 <= 820\leq 820 40 d > 0 , 65 d > 0 , 65 d > 0,65d>0,65 ≤ 800 ≤ 800 <= 800\leq 800 40 Cold-drawn a a ^(a){ }^{a} 冷拔 a a ^(a){ }^{a} 0 , 2 ≤ d ≤ 0 , 7 0 , 2 ≤ d ≤ 0 , 7 0,2 <= d <= 0,70,2 \leq d \leq 0,7 1600 ≤ R m ≤ 1850 1600 ≤ R m ≤ 1850 1600 <= R_(m) <= 18501600 \leq R_{\mathrm{m}} \leq 1850 -

a 以冷拔状态订购的线材可以按照买方指定的更高抗拉强度水平提供。 b 根据 ASTM F138 和 ASTM F 139 调整的值。经 ASTM F138 许可转载，版权所有 ASTM International。 完整标准的副本可从 www.astm.org
a Wire ordered in the cold-drawn condition can be supplied to higher tensile strength levels as specified by the purchaser.
b Values adjusted to ASTM F138 and ASTM F 139. Reprinted with permission from ASTM F138, copyright ASTM International.
A copy of the complete standard may be obtained from www.astm.org
a Wire ordered in the cold-drawn condition can be supplied to higher tensile strength levels as specified by the purchaser. b Values adjusted to ASTM F138 and ASTM F 139. Reprinted with permission from ASTM F138, copyright ASTM International. A copy of the complete standard may be obtained from www.astm.org| a Wire ordered in the cold-drawn condition can be supplied to higher tensile strength levels as specified by the purchaser. | | :--- | | b Values adjusted to ASTM F138 and ASTM F 139. Reprinted with permission from ASTM F138, copyright ASTM International. | | A copy of the complete standard may be obtained from www.astm.org |
Condition "Diameter d mm" "Tensile strength R_(m) MPa" "Minimum percentage elongation after fracture A_(min),%" Annealed 0,025 <= d <= 0,13 490 <= R_(m) <= 1000^(b) 30 0,13 < d <= 0,23 <= 930 30 0,38 < d <= 0,5 <= 860 40 0,5 < d <= 0,65 <= 820 40 d > 0,65 <= 800 40 Cold-drawn ^(a) 0,2 <= d <= 0,7 1600 <= R_(m) <= 1850 - "a Wire ordered in the cold-drawn condition can be supplied to higher tensile strength levels as specified by the purchaser. b Values adjusted to ASTM F138 and ASTM F 139. Reprinted with permission from ASTM F138, copyright ASTM International. A copy of the complete standard may be obtained from www.astm.org" | Condition | Diameter <br> d <br> mm | Tensile strength <br> $R_{\mathrm{m}}$ <br> MPa | Minimum percentage <br> elongation after fracture <br> $A_{\min }$ <br> $\%$ | | :---: | :---: | :---: | :---: | | Annealed | $0,025 \leq d \leq 0,13$ | $490 \leq R_{\mathrm{m}} \leq 1000^{\mathrm{b}}$ | 30 | | | $0,13<d \leq 0,23$ | $\leq 930$ | 30 | | | $0,38<d \leq 0,5$ | $\leq 860$ | 40 | | | $0,5<d \leq 0,65$ | $\leq 820$ | 40 | | | $d>0,65$ | $\leq 800$ | 40 | | Cold-drawn ${ }^{a}$ | $0,2 \leq d \leq 0,7$ | $1600 \leq R_{\mathrm{m}} \leq 1850$ | - | | a Wire ordered in the cold-drawn condition can be supplied to higher tensile strength levels as specified by the purchaser. <br> b Values adjusted to ASTM F138 and ASTM F 139. Reprinted with permission from ASTM F138, copyright ASTM International. <br> A copy of the complete standard may be obtained from www.astm.org | | | |
Table 5-Mechanical properties of strip and sheet
表 5 - 带材和片材的机械性能
Condition 条件 Tensile strength 抗张强度

最小验证强度或屈服强度 R p 0 , 2 , min R p 0 , 2 , min R_(p0,2,min)R_{\mathrm{p} 0,2, \min }
Minimum proof strength or
yield strength
R p 0 , 2 , min R p 0 , 2 , min R_(p0,2,min)R_{\mathrm{p} 0,2, \min }
Minimum proof strength or yield strength R_(p0,2,min)| Minimum proof strength or | | :---: | | yield strength | | $R_{\mathrm{p} 0,2, \min }$ |

骨折后的最小伸长率
Minimum percentage
elongation after fracture
Minimum percentage elongation after fracture| Minimum percentage | | :---: | | elongation after fracture |
R m R m R_(m)R_{\mathrm{m}} A min A min A_(min)A_{\min }
MPa 兆帕 190 40
Annealed 退火 490 ≤ R m ≤ 690 490 ≤ R m ≤ 690 490 <= R_(m) <= 690490 \leq R_{\mathrm{m}} \leq 690 690 10
Cold-worked 冷加工 860 ≤ R m ≤ 1100 860 ≤ R m ≤ 1100 860 <= R_(m) <= 1100860 \leq R_{\mathrm{m}} \leq 1100
MPa 兆帕
MPa| MPa | | :---: |
Condition Tensile strength "Minimum proof strength or yield strength R_(p0,2,min)" "Minimum percentage elongation after fracture" R_(m) A_(min) MPa 190 40 Annealed 490 <= R_(m) <= 690 690 10 Cold-worked 860 <= R_(m) <= 1100 "MPa" | Condition | Tensile strength | Minimum proof strength or <br> yield strength <br> $R_{\mathrm{p} 0,2, \min }$ | Minimum percentage <br> elongation after fracture | | :---: | :---: | :---: | :---: | | | $R_{\mathrm{m}}$ | $A_{\min }$ | | | | MPa | 190 | 40 | | Annealed | $490 \leq R_{\mathrm{m}} \leq 690$ | 690 | 10 | | Cold-worked | $860 \leq R_{\mathrm{m}} \leq 1100$ | MPa | |
ISO 5832-1:2024(en) ISO 5832-1：2024（英文）
Table 6 - Test methods
表 6 - 测试方法
Parameter 参数 (Sub)clause （子）子句 Test method 测试方法

化学成分 - 硅 - 锰 - 硫 - 磷 - 其他元素
Chemical composition
- silicon
- manganese
- sulfur
- phosphorus
- other elements
Chemical composition - silicon - manganese - sulfur - phosphorus - other elements| Chemical composition | | :--- | | - silicon | | - manganese | | - sulfur | | - phosphorus | | - other elements |
 Clause 4 第 4 条

认证 认证 认证 认证
ISO 439
ISO 629
ISO 671
ISO 10714
ISO 439 ISO 629 ISO 671 ISO 10714| ISO 439 | | :--- | | ISO 629 | | ISO 671 | | ISO 10714 |
Recognized analytical procedures (ISO methods, where
these exist)
ISO 439
ISO 629
ISO 671
ISO 10714
ISO 439 认证 ISO 629 认证 ISO 671 认证 ISO 10714|ISO 439 认证 | |:--- | |ISO 629 认证 | |ISO 671 认证 | |ISO 10714 国际标准化组织 （ISO 10714） |
公认的分析程序（ISO 方法，如果存在）
ISO 439,ISO 629,ISO 671,ISO 10714 Recognized analytical procedures (ISO methods, where these exist)| ISO 439 <br> ISO 629 <br> ISO 671 <br> ISO 10714 | | :--- | | Recognized analytical procedures (ISO methods, where | | these exist) |
Grain size 粒度 5.1 ISO 643a ISO 643a 认证 Microstructure 组织 5.2

a） 经金相制备的纵截面和横截面退火样; b） 使用公认的技术，以 100× 放大倍率检查物种是否存在 δ 铁素体和碳化物。
a) Metallographically prepared specimens in the
annealed condition from longitudinal and transverse
sections;
b) Using recognized techniques, examine the speci-
mens at 100× magnification for the presence or absence
of delta ferrite and carbides.
a) Metallographically prepared specimens in the annealed condition from longitudinal and transverse sections; b) Using recognized techniques, examine the speci- mens at 100× magnification for the presence or absence of delta ferrite and carbides.| a) Metallographically prepared specimens in the | | :--- | | annealed condition from longitudinal and transverse | | sections; | | b) Using recognized techniques, examine the speci- | | mens at 100× magnification for the presence or absence | | of delta ferrite and carbides. |
Inclusion content 包含内容 5.3 ISO 4967:2013, Method A ISO 4967：2013，方法 A

机械性能 - 拉伸强度 - 屈服强度或屈服强度 - 断裂后伸长率
Mechanical properties
- tensile strength
- proof strength or yield strength
- percentage elongation after fracture
Mechanical properties - tensile strength - proof strength or yield strength - percentage elongation after fracture| Mechanical properties | | :--- | | - tensile strength | | - proof strength or yield strength | | - percentage elongation after fracture |
Clause 6 第 6 条 ISO 6892-1 ISO 6892-1 认证 Parameter (Sub)clause Test method "Chemical composition - silicon - manganese - sulfur - phosphorus - other elements" Clause 4 "ISO 439,ISO 629,ISO 671,ISO 10714 Recognized analytical procedures (ISO methods, where these exist)" Grain size 5.1 ISO 643a Microstructure 5.2 "a) Metallographically prepared specimens in the annealed condition from longitudinal and transverse sections; b) Using recognized techniques, examine the speci- mens at 100× magnification for the presence or absence of delta ferrite and carbides." Inclusion content 5.3 ISO 4967:2013, Method A "Mechanical properties - tensile strength - proof strength or yield strength - percentage elongation after fracture" Clause 6 ISO 6892-1| Parameter | (Sub)clause | Test method | | :---: | :---: | :---: | | Chemical composition <br> - silicon <br> - manganese <br> - sulfur <br> - phosphorus <br> - other elements | Clause 4 | ISO 439 <br> ISO 629 <br> ISO 671 <br> ISO 10714 <br> Recognized analytical procedures (ISO methods, where <br> these exist) | | Grain size | 5.1 | ISO 643a | | Microstructure | 5.2 | a) Metallographically prepared specimens in the <br> annealed condition from longitudinal and transverse <br> sections; <br> b) Using recognized techniques, examine the speci- <br> mens at 100× magnification for the presence or absence <br> of delta ferrite and carbides. | | Inclusion content | 5.3 | ISO 4967:2013, Method A | | Mechanical properties <br> - tensile strength <br> - proof strength or yield strength <br> - percentage elongation after fracture | Clause 6 | ISO 6892-1 |

Bibliography 书目

[1] ASTM F138, Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
[1] ASTM F138，用于外科植入物的锻造 18 铬 14 镍 2.5 钼不锈钢棒和线的标准规范 （UNS S31673）
[2] ASTM F139, Standard Specification for Wrought-18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
[2] ASTM F139，用于外科植入物的锻造 18 铬 14 镍 2.5 钼不锈钢板和带的标准规范 （UNS S31673）
ICS 11.040.40 国际编码系统 11.040.40
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