SIST EN ISO 5832-1:2024
(Main)Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)
This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
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.
NOTE 2 The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.
Chirurgische Implantate - Metallische Werkstoffe - Teil 1: Nichtrostender Stahl (ISO 5832-1:2024)
Dieses Dokument legt die Eigenschaften und die zu deren Bestimmung anzuwendenden Prüfverfahren für nichtrostenden Stahl zur Verwendung für die Herstellung von chirurgischen Implantaten fest.
ANMERKUNG 1 Die mechanischen Eigenschaften einer Probe, die einem Fertigprodukt aus der hier beschriebenen Legierung entnommen wurde, können von den in diesem Dokument festgelegten abweichen.
ANMERKUNG 2 Die in diesem Dokument beschriebene Legierung stimmt mit UNS S31673 nach ASTM F 138 und ASTM F 139 überein.
Implants chirurgicaux - Matériaux métalliques - Partie 1: Acier inoxydable corroyé (ISO 5832-1:2024)
Le présent document spécifie les caractéristiques de l'acier inoxydable corroyé utilisé dans la fabrication des implants chirurgicaux, et les méthodes d'essai correspondantes.
NOTE 1 Les propriétés mécaniques d'un échantillon prélevé sur un produit fini fabriqué avec cet alliage peuvent différer de celles spécifiées dans le présent document.
NOTE 2 L'alliage décrit dans le présent document correspond à la nuance UNS S31673 dans l'ASTM F138 et l'ASTM F139.
Vsadki (implantati) za kirurgijo - Kovinski materiali - 1. del: Nerjavno jeklo (ISO 5832-1:2024)
Standard ISO 5832-1:2016 določa lastnosti in ustrezne preskusne metode za nerjavno jeklo, ki se uporablja pri izdelavi vsadkov (implantatov) za kirurgijo.
OPOMBA 1: Mehanske lastnosti vzorca končnega izdelka iz te zlitine se lahko razlikujejo od lastnosti, ki so določene v tem delu standarda ISO 5832.
OPOMBA 2: Zlitina, ki je opisana v tem delu standarda ISO 5832, ustreza jeklu UNS S31673 iz standarda ASTM F138/ASTM F139 in oznaki zlitine 1.4441 iz umaknjenega standarda DIN 17443.
General Information
Relations
Overview
EN ISO 5832-1:2024 (Corrected version 2025-06) specifies the chemical, microstructural and mechanical characteristics - and the corresponding test methods - for wrought stainless steel intended for the manufacture of surgical implants. The alloy corresponds to UNS S31673 in ASTM F138 / F139. The standard covers raw material requirements (not finished-device design), with referenced test methods for chemical analysis, microstructure and tensile testing.
Key topics and technical requirements
- Scope: Characteristics and test methods for wrought stainless steel used in surgical implants.
- Chemical composition: Limits given for main elements (examples from Table 1):
- Carbon ≤ 0.030%
- Silicon ≤ 0.75%
- Manganese ≤ 2.0%
- Phosphorus ≤ 0.025%
- Sulfur ≤ 0.010%
- Nitrogen ≤ 0.10%
- Chromium 17.0–19.0%
- Molybdenum 2.25–3.00%
- Nickel 13.0–15.0%
- Copper ≤ 0.50%
- Cobalt < 0.10%
- Iron: balance
- The molybdenum and chromium contents must satisfy the C-value requirement from Formula (1); the computed C shall be not less than 26.
- Microstructure:
- Austenitic grain size shall be no coarser than grain size No. 5.
- Steel shall be free from delta ferrite, chi or sigma phases.
- Non‑metallic inclusion limits specified (Table 2) for sulfides, aluminates, silicates and oxides (thin ≤ 1.5, thick ≤ 1). Vacuum or electroslag melting may be needed to meet cleanliness.
- Mechanical properties & testing:
- Tensile properties specified for bars, wires, sheet and strip (refer to Tables 3–5 in the standard).
- Sample preparation and tensile testing referenced to ISO 377, ISO 6892-1 and ISO 404.
- Original gauge length (Lo) requirements and retest rules are defined; note that mechanical properties of a finished product can differ from raw‑material values.
Applications and users
- Primary application: non‑active surgical implants (orthopaedic and dental implants, prosthetics components made from wrought stainless steel).
- Typical users: implant manufacturers, medical device material suppliers, metallurgical and quality laboratories, regulatory and conformity-assessment bodies, purchasing/specification engineers.
- Practical value: ensures consistent alloy chemistry, cleanliness, microstructure and mechanical performance to support biocompatibility, corrosion resistance and mechanical reliability of implant components.
Related standards and references
- ISO 5832 series (harmonized parts)
- ASTM F138 / F139 (UNS S31673 equivalence)
- Test method references: ISO 377, ISO 404, ISO 4967, ISO 643, ISO 6892-1, ISO 439, ISO 629, ISO 671, ISO 10714.
Keywords: EN ISO 5832-1:2024, ISO 5832-1, wrought stainless steel, surgical implants, UNS S31673, ASTM F138, implant material standards, microstructure, chemical composition, tensile test.
Frequently Asked Questions
SIST EN ISO 5832-1:2024 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)". This standard covers: This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants. 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. NOTE 2 The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.
This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants. 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. NOTE 2 The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.
SIST EN ISO 5832-1:2024 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 5832-1:2024 has the following relationships with other standards: It is inter standard links to SIST EN ISO 5832-1:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 5832-1:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Vsadki (implantati) za kirurgijo - Kovinski materiali - 1. del: Nerjavno jeklo (ISO
5832-1:2024)
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-
1:2024)
Chirurgische Implantate - Metallische Werkstoffe - Teil 1: Nichtrostender Stahl (ISO 5832
-1:2024)
Implants chirurgicaux - Matériaux métalliques - Partie 1: Acier inoxydable corroyé (ISO
5832-1:2024)
Ta slovenski standard je istoveten z: EN ISO 5832-1:2024
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 5832-1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2024
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5832-1:2019
English Version
Implants for surgery - Metallic materials - Part 1: Wrought
stainless steel (ISO 5832-1:2024)
Implants chirurgicaux - Matériaux métalliques - Partie Chirurgische Implantate - Metallische Werkstoffe - Teil
1: Acier inoxydable corroyé (ISO 5832-1:2024) 1: Nichtrostender Stahl (ISO 5832-1:2024)
This European Standard was approved by CEN on 23 June 2023.
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.
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.
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5832-1:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
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.
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.
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.
This document supersedes 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.
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.
Endorsement notice
The text of ISO 5832-1:2024 has been approved by CEN as EN ISO 5832-1:2024 without any
modification.
International
Standard
ISO 5832-1
Sixth edition
Implants for surgery — Metallic
2024-04
materials —
Part 1:
Wrought stainless steel
Implants chirurgicaux — Matériaux métalliques —
Partie 1: Acier inoxydable corroyé
Reference number
ISO 5832-1:2024(en) © ISO 2024
ISO 5832-1:2024(en)
© ISO 2024
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 5832-1:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Chemical composition . 2
4.1 Test samples .2
4.2 Cast analysis .2
5 Microstructure in the fully annealed condition . 2
5.1 Grain size .2
5.2 Microstructure .3
5.3 Inclusion content .3
6 Mechanical properties . 3
6.1 Test pieces . .3
6.2 Tensile test .3
6.3 Gauge length .3
7 Test methods . 3
Bibliography . 6
iii
ISO 5832-1:2024(en)
Foreword
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.
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 draws attention to the possibility that the implementation of this document may involve th
...
SIST EN ISO 5832-1:2024 표준 문서는 수술을 위한 임플란트에 사용되는 가공 스테인리스 스틸의 특성 및 해당 시험 방법을 명확하게 규정하고 있습니다. 이 표준의 범위는 외과용 임플란트 제작에 필요한 금속 재료의 품질을 보장하는 데 중요한 역할을 합니다. 가장 큰 강점 중 하나는 이 문서가 임플란트에 사용될 가공 스테인리스 스틸의 기계적 특성을 구체적으로 정의한다는 점입니다. 이는 의료 분야에서 안전성과 효과성을 보장하는 데 필수적인 요소입니다. 또한, 이 표준은 UNS S31673에 해당하는 합금을 명확히 하는 부분이 있어, ASTM F138 및 ASTM F139와의 연계성을 제공합니다. 이는 제조업체가 합금의 품질을 보증하는 데 도움을 줄 뿐만 아니라, 국제적으로 통일된 기준을 따르게 합니다. SIST EN ISO 5832-1:2024의 중요성은 외과적 임플란트의 생산 과정에서 일어날 수 있는 기계적 성질의 변화를 감안하여, 최종 제품에서의 기계적 특성이 표준에 명시된 것과 다를 수 있음을 인지하게 한다는 점입니다. 이러한 인지는 제조업체가 품질 보증 프로세스를 강화하도록 유도하며, 결과적으로 환자에게 제공되는 의료 서비스의 품질을 향상시키는 데 기여합니다. 결론적으로, SIST EN ISO 5832-1:2024 표준은 외과적 임플란트에 필수적인 가공 스테인리스 스틸의 특성을 명확히 하고, 시험 방법을 통해 일관된 품질 보증을 가능하게 합니다. 이는 의료 기술의 발전과 환자의 안전을 동시에 고려한 중요한 기준이 됩니다.
SIST EN ISO 5832-1:2024は、外科用インプラントに使用される鍛造ステンレス鋼の特性および対応する試験方法を規定している文書です。この標準は、外科用インプラントの製造における鍛造ステンレス鋼の品質と安全性を確保するために非常に重要です。 この標準の範囲は、外科用インプラントに必要な機械的特性を明確に説明することにあります。特に、仕上げられた製品から得られたサンプルの機械的特性が、この文書に規定された特性と異なる可能性があることを注記しており、製造業者に注意を促しています。これは、製品が実際に使用される環境での性能を確認するために役立ちます。 また、この標準は、ASTM F138およびF139で定義されるUNS S31673の合金に対応していることが明記されており、国際的な標準との整合性をもたらします。この点は、製品のグローバルな受容性や取引を促進する上での強みとなります。 SIST EN ISO 5832-1:2024は、外科用インプラントのための鍛造ステンレス鋼に関する技術的および品質的な要件を統一化することにより、業界全体の安全基準を引き上げる重要な役割を果たしています。このように、標準化文書が持つ意義や強みは、外科用インプラントの製造に関わる全ての関係者にとって非常に価値のあるものです。
Die Norm SIST EN ISO 5832-1:2024 ist ein bedeutendes Dokument, das die Eigenschaften und entsprechenden Prüfmethoden für gewalzten Edelstahl festlegt, der in der Herstellung von chirurgischen Implantaten verwendet wird. Dieser Standard bietet eine klare und präzise Grundlage, die es Herstellern und Entwicklern von chirurgischen Implantaten ermöglicht, Materialien auszuwählen, die den erforderlichen Sicherheits- und Leistungsstandards entsprechen. Ein besonders hervorzuhebender Aspekt dieser Norm ist ihre umfassende Abdeckung der mechanischen Eigenschaften des gewalzten Edelstahls. Die detaillierten Testmethoden, die in diesem Dokument beschrieben werden, gewährleisten, dass die produzierten Implantate sowohl in Bezug auf ihre Struktur als auch auf ihre Funktionsfähigkeit den hohen Anforderungen im chirurgischen Bereich gerecht werden. Die Norm betont auch die Relevanz des Werkstoffs, wobei der gewalzte Edelstahl in der medizinischen Anwendung als besonders korrosionsbeständig und biologisch verträglich eingestuft wird. Dies macht ihn zu einer erstklassigen Wahl für verschiedene Implantatanwendungen, insbesondere im Hinblick auf die Langzeitverwendung im menschlichen Körper. Zudem wird in der Norm auf die spezifischen Legierungen verwiesen, wie etwa die Verbindung zu UNS S31673 in den ASTM-Standards F138 und F139, was die internationale Relevanz und die Sicherheit der verwendeten Materialien unterstreicht. Zusammengefasst bietet die SIST EN ISO 5832-1:2024 eine entscheidende Ressource für Unternehmen im Gesundheitssektor, die im Bereich der chirurgischen Implantate tätig sind. Die Norm sichert die Qualität und Zuverlässigkeit der Metallmaterialien und trägt somit zur Verbesserung der Patientensicherheit und der chirurgischen Ergebnisse bei.
Le document SIST EN ISO 5832-1:2024 est une norme essentielle pour les matériaux métalliques utilisés dans la fabrication d'implants chirurgicaux, précisant les caractéristiques et les méthodes d'essai pour l'acier inoxydable laminé. Son étendue couvre la définition des exigences mécaniques, garantissant que les composants en acier inoxydable utilisés dans les dispositifs médicaux répondent aux standards de sécurité et de performance nécessaires. Parmi ses forces, cette norme met en avant la clarté des spécifications relatives à l'acier inoxydable, facilitant ainsi la compréhension pour les fabricants et les laboratoires d'essai. La précision sur les procédés d'essai permet une évaluation rigoureuse des propriétés mécaniques des échantillons, contribuant à une meilleure fiabilité des implants. La pertinence de SIST EN ISO 5832-1:2024 est également mise en évidence par son rapport avec d'autres normes importantes, telles que les références UNS S31673, ASTM F138 et ASTM F139. Cela permet une harmonisation au niveau international des exigences pour l'acier inoxydable, ce qui est crucial dans un secteur où la qualité et la sécurité des implants sont primordiales. En somme, la norme SIST EN ISO 5832-1:2024 constitue un pilier fondamental pour l'industrie des dispositifs médicaux, assurant que les implants fabriqués répondent aux standards les plus élevés tout en offrant une transparence essentielle dans les méthodes de test et les propriétés mécaniques définies.
The SIST EN ISO 5832-1:2024 standard serves as a comprehensive guide for the characteristics and testing methods of wrought stainless steel, specifically intended for use in surgical implants. The document is pivotal as it delineates critical specifications necessary for ensuring the quality and safety of metallic materials used in medical applications. One of the significant strengths of this standard is its detailed outline of mechanical properties required for wrought stainless steel, which is fundamental for the performance and longevity of surgical implants. The mention of mechanical properties not only encompasses tensile strength but also includes considerations for fatigue and corrosion resistance, which are crucial for materials that will be subjected to the harsh environments of the human body. Moreover, the standard’s alignment with established UNS S31673 designations in ASTM F138 and ASTM F139 enhances its relevance within the global context of medical device manufacturing. This integration streamlines the identification and acceptance of materials across various regions, making it indispensable for manufacturers aiming to comply with international regulations. The outlined testing methods provide an essential framework for verifying the integrity and reliability of the stainless steel used, ensuring that manufacturers can consistently produce high-quality surgical implants. The notes specifying potential discrepancies in mechanical properties between raw materials and finished products underscore the importance of rigorous testing in real-world applications. In summary, the SIST EN ISO 5832-1:2024 standard is integral for stakeholders in the medical device sector, promoting best practices in the selection and evaluation of metallic materials for surgical implants. Its relevance is underscored by its alignment with existing industry standards, thereby boosting confidence among manufacturers and healthcare providers alike in the reliability of the materials used for patient care.
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