SIST EN ISO 5832-2:2025
(Main)Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2025)
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2025)
This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants.
Six grades of titanium based on tensile strength are listed in Table 2.
NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily conform with those specified in this document.
Chirurgische Implantate - Metallische Werkstoffe - Teil 2: Unlegiertes Titan (ISO 5832-2:2025)
Dieses Dokument legt die Eigenschaften und die dazugehörigen Prüfverfahren in Bezug auf unlegiertes Titan fest, das zur Herstellung von chirurgischen Implantaten verwendet wird.
Sechs Titan-Güten, die verschiedenen Zugfestigkeiten entsprechen, sind in Tabelle 2 aufgeführt.
ANMERKUNG Die mechanischen Eigenschaften einer Probe, die einem aus diesem Metall hergestellten Fertigprodukt entnommen wurde, stimmen nicht notwendigerweise mit den Festlegungen in diesem Dokument überein.
Implants chirurgicaux - Matériaux métalliques - Partie 2: Titane non allié (ISO 5832-2:2025)
Le présent document spécifie les caractéristiques du titane non allié utilisé dans la fabrication des implants chirurgicaux, ainsi que les méthodes d’essai correspondantes.
Le Tableau 2 répertorie six nuances de titane fondées sur la résistance à la traction.
NOTE Les propriétés mécaniques d’un échantillon prélevé sur un produit fini fabriqué avec ce métal ne sont pas nécessairement conformes aux valeurs spécifiées dans le présent document.
Vsadki (implantati) za kirurgijo - Kovinski materiali - 2. del: Nelegirani titan (ISO 5832-2:2025)
Ta dokument določa lastnosti in zadevne preskusne metode za nelegirani titan, ki se uporablja pri izdelavi vsadkov za kirurgijo. V preglednici 2 je navedenih šest stopenj natezne trdnosti titana. OPOMBA: Mehanske lastnosti vzorca končnega izdelka iz te kovine niso nujno v skladu z lastnostmi, ki so določene v tem dokumentu.
General Information
- Status
- Published
- Public Enquiry End Date
- 29-Apr-2025
- Publication Date
- 01-Oct-2025
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 26-Sep-2025
- Due Date
- 01-Dec-2025
- Completion Date
- 02-Oct-2025
Relations
- Effective Date
- 01-Nov-2025
Overview
EN ISO 5832-2:2025 (endorsed by CEN as EN ISO 5832-2:2025) specifies the required characteristics and test methods for unalloyed titanium intended for the manufacture of surgical implants. The fifth edition replaces the 2018 edition and harmonizes the content with other parts of the ISO 5832 series. The document covers chemical composition, microstructure and mechanical property requirements of raw implant material and lists six strength-based grades referenced in Table 2.
Note: This standard applies to raw material; mechanical properties of finished devices can differ because of design and fabrication.
Key Topics
Grades and mechanical classification: Six grades are defined (including Grade 1 ELI, Grade 1, Grade 2, Grade 3, Grade 4A and Grade 4B). Grades are distinguished primarily by tensile/proof strengths and form condition (e.g. annealed or cold-worked).
Chemical composition controls: The standard specifies the elements to be limited in unalloyed titanium for implants, including nitrogen, carbon, hydrogen, iron and oxygen, with titanium as the balance. Cobalt is noted as a controlled impurity (<0.10 % mass fraction) in the table of chemical limits.
Microstructure requirements: Titanium in the annealed condition shall have a uniform microstructure with grain size no coarser than No. 5. At ×100 magnification no inclusions, foreign phases or continuous alpha-case layers shall be visible.
Mechanical properties and testing: Tensile and bend requirements are set out for each grade. The standard details sampling, retest rules and acceptance criteria. Representative tensile test specimens are to be prepared in accordance with ISO 6892-1. Bend testing for sheet and strip uses ISO 7438 with mandrel diameters specified by grade.
Test methods and conformity: Recognized analytical procedures and referenced standards (e.g., ISO 643, ISO 6892-1, ISO 7438, ASTM E112) are mandated for verifying conformity to composition, grain size and mechanical properties.
Applications
- Production and specification of raw unalloyed titanium for medical device manufacturers (orthopaedics, dental implants, prosthetics and other surgical implant components).
- Material selection and procurement: designers and QA teams use this standard to ensure biocompatible, traceable and grade-appropriate titanium stock for downstream device manufacture.
- Regulatory and conformity evidence: supports material-level compliance during device certification and technical documentation.
Related Standards
- ISO 5832 series (other parts covering stainless steels, cobalt alloys and other metallic implant materials)
- ISO 6892-1 - Tensile testing of metallic materials (room temperature)
- ISO 7438 - Bend test for metallic materials
- ISO 643 / ASTM E112 - Grain size determination
- ASTM F67 - Related specification for unalloyed titanium for surgical applications (referenced in the bibliography)
Practical value: EN ISO 5832-2:2025 provides a clear framework for manufacturers and specifiers to control raw unalloyed titanium quality through standardized composition, microstructure, and mechanical testing - enabling consistent, grade-based supply of implantable titanium materials.
Frequently Asked Questions
SIST EN ISO 5832-2:2025 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2025)". This standard covers: This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile strength are listed in Table 2. NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily conform with those specified in this document.
This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile strength are listed in Table 2. NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily conform with those specified in this document.
SIST EN ISO 5832-2:2025 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 5832-2:2025 has the following relationships with other standards: It is inter standard links to SIST EN ISO 5832-2:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 5832-2:2025 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-november-2025
Nadomešča:
SIST EN ISO 5832-2:2018
Vsadki (implantati) za kirurgijo - Kovinski materiali - 2. del: Nelegirani titan (ISO
5832-2:2025)
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2025)
Chirurgische Implantate - Metallische Werkstoffe - Teil 2: Unlegiertes Titan (ISO 5832-
2:2025)
Implants chirurgicaux - Matériaux métalliques - Partie 2: Titane non allié (ISO 5832-
2:2025)
Ta slovenski standard je istoveten z: EN ISO 5832-2:2025
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 5832-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2025
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 5832-2:2018
English Version
Implants for surgery - Metallic materials - Part 2:
Unalloyed titanium (ISO 5832-2:2025)
Implants chirurgicaux - Matériaux métalliques - Partie Chirurgische Implantate - Metallische Werkstoffe - Teil
2: Titane non allié (ISO 5832-2:2025) 2: Unlegiertes Titan (ISO 5832-2:2025)
This European Standard was approved by CEN on 12 September 2025.
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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5832-2:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5832-2:2025) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery " in collaboration with Technical Committee CEN/TC 55 “Dentistry” 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 March 2026, and conflicting national standards shall
be withdrawn at the latest by March 2026.
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 5832-2:2018.
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 5832-2:2025 has been approved by CEN as EN ISO 5832-2:2025 without any
modification.
International
Standard
ISO 5832-2
Fifth edition
Implants for surgery — Metallic
2025-09
materials —
Part 2:
Unalloyed titanium
Implants chirurgicaux — Matériaux métalliques —
Partie 2: Titane non allié
Reference number
ISO 5832-2:2025(en) © ISO 2025
ISO 5832-2:2025(en)
© ISO 2025
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 5832-2:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Chemical composition . 1
5 Microstructure. 2
6 Mechanical properties . 2
6.1 Tensile properties .2
6.2 Bending properties .2
7 Test methods . 3
Bibliography . 4
iii
ISO 5832-2:2025(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, th
...
La norme SIST EN ISO 5832-2:2025 est un document essentiel qui spécifie les caractéristiques des matériaux métalliques utilisés dans la fabrication des implants chirurgicaux, en se concentrant sur le titane non allié. Cette norme est de grande pertinence pour les fabricants d'implants, car elle établit des critères précis et des méthodes d'essai pour garantir la qualité et la fiabilité des produits utilisés dans des applications médicales critiques. Une de ses forces réside dans sa classification en six grades de titane, fondée sur la résistance à la traction, présentée clairement dans le tableau 2. Cette hiérarchisation permet aux concepteurs et ingénieurs de sélectionner le grade approprié en fonction des exigences spécifiques de chaque application chirurgicale, assurant ainsi la performance et la sécurité des implants. De plus, la norme aborde la question importante des propriétés mécaniques des échantillons prélevés sur des produits finis. En soulignant que ces propriétés peuvent ne pas toujours correspondre aux spécifications énoncées, elle avertit les utilisateurs de la nécessité d'effectuer des contrôles rigoureux lors de la production et de l'évaluation des matériaux, renforçant ainsi la responsabilité des fabricants dans la création de dispositifs médicaux fiables. En somme, la SIST EN ISO 5832-2:2025 joue un rôle crucial dans la standardisation des matériaux utilisés pour les implants chirurgicaux. Sa portée bien définie, ses grades spécifiques de titane et ses avertissements relatifs aux propriétés mécaniques font de cette norme un outil précieux pour toute organisation impliquée dans le secteur médical.
SIST EN ISO 5832-2:2025 문서는 수술용 임플란트에 사용되는 비합금 티타늄의 특성과 해당 시험 방법을 명시하고 있습니다. 이 표준은 비합금 티타늄의 다양한 기계적 성질을 보장하여, 수술용 임플란트 제조에 필요한 높은 안전성과 신뢰성을 제공합니다. 특히, 이 표준에서는 인장 강도를 기준으로 한 티타늄의 6가지 등급을 표 2에 나열하여, 사용자가 요구하는 성능에 적합한 재료를 선택할 수 있도록 돕습니다. 이는 의료 기기 산업에서 금속 재료의 일관성과 품질을 유지하는 데 매우 중요한 요소입니다. SIST EN ISO 5832-2:2025의 강점은 명확한 시험 방법과 특성 규명이 포함되어 있어, 임플란트를 설계하고 제조하는 공정에서의 재료 선택 및 품질 관리를 용이하게 한다는 점입니다. 이 표준은 비합금 티타늄이 수술용 임플란트에 적합한지에 대한 신뢰할 수 있는 기준을 제공함으로써, 의료 분야에서의 활용도를 높입니다. 또한, 이 표준은 기계적 특성이 실제 제품의 샘플에서 항상 제공된 기준과 일치하지 않을 수 있다는 점을 명시하고 있어, 제조업체들에게 중요한 경고입니다. 이는 품질 관리를 통해 최종 제품이 예상한 성능을 발휘하도록 하는 데 필수적입니다. 따라서 SIST EN ISO 5832-2:2025는 비합금 티타늄을 사용하는 의료 기기 제조에 있어 그 범위와 적용성이 매우 크며, 해당 표준의 준수는 제조업체에게 안전하고 효과적인 임플란트를 보장하는 핵심 요소로 작용합니다.
Die SIST EN ISO 5832-2:2025 Norm ist ein entscheidendes Dokument, das spezifische Eigenschaften und Prüfmethoden für unlegiertes Titan festlegt, welches in der Herstellung von chirurgischen Implantaten verwendet wird. Der Geltungsbereich dieser Norm ist besonders relevant für Hersteller von Implantaten, da unlegiertes Titan aufgrund seiner biokompatiblen Eigenschaften und hohen Festigkeit weit verbreitet in der Medizinindustrie eingesetzt wird. Ein herausragendes Merkmal dieser Norm ist die systematische Kategorisierung in sechs Titanqualitäten, die auf der Zugfestigkeit basieren. Diese klare Klassifizierungsstruktur ermöglicht es Herstellern, die geeignete Titanqualität je nach den spezifischen Anforderungen ihrer Implantate auszuwählen, was sowohl die Produktsicherheit als auch die Leistungsfähigkeit erhöht. Die im Dokument enthaltenen Prüfmethoden sind ebenfalls von großer Bedeutung, da sie sicherstellen, dass die mechanischen Eigenschaften des Titanmaterials vor und nach der Verwendung in einem klinischen Umfeld überwacht werden. Dabei wird beachtet, dass die mechanischen Eigenschaften eines aus einem Fertigprodukt entnommenen Proben nicht unbedingt den in diesem Dokument festgelegten Spezifikationen entsprechen, was auf die Komplexität der Materialverarbeitung hinweist. Insgesamt stärkt die SIST EN ISO 5832-2:2025 Norm die Relevanz unlegierten Titans in der Medizin und fördert die Einführung hoher Qualitätsstandards in der Herstellung von chirurgischen Implantaten. Die umfassenden Richtlinien und detaillierten Anforderungen stellen sicher, dass die Hersteller über die erforderlichen Informationen verfügen, um Produkte zu entwickeln, die sowohl sicher als auch effektiv sind.
The SIST EN ISO 5832-2:2025 standard outlines the specifications for unalloyed titanium utilized in the manufacture of surgical implants, providing a critical framework for medical devices. The document's scope is comprehensive, detailing the necessary characteristics and test methods required to ensure that the titanium used meets the specific demands of surgical applications. One of the key strengths of this standard is its classification of six grades of titanium based on tensile strength, as presented in Table 2. This classification enables manufacturers to select the appropriate titanium grade depending on the mechanical requirements of the surgical implants they are producing. By doing so, it ensures consistency and reliability across different manufacturing processes, thus enhancing patient safety and device performance. Furthermore, the inclusion of precise test methods for evaluating the mechanical properties of unalloyed titanium adds another layer of rigor to the standard. This aspect is vital as it helps manufacturers to ensure that the titanium utilized in their implants meets the necessary quality and safety benchmarks set forth within the healthcare industry. The relevance of SIST EN ISO 5832-2:2025 cannot be overstated, especially as the demand for high-performance surgical implants continues to rise. By standardizing the specifications and testing methodologies for unalloyed titanium, this document plays a crucial role in promoting the development of innovative implant technologies and improving patient outcomes across various surgical disciplines. Overall, the SIST EN ISO 5832-2:2025 standard serves as a vital resource for manufacturers and stakeholders in the medical field, ensuring that surgical implants made from unalloyed titanium are produced with the utmost quality and efficacy.
SIST EN ISO 5832-2:2025は、外科用インプラントの製造に使用される非合金チタンに関する規格です。この文書は、チタンの特性とこれに対応する試験方法を明確に定義しています。特に、この技術的規格では、引張強度に基づいて六つのグレードのチタンがTable 2にリストされています。この詳細な分類は、外科用インプラントの品質を確保する上で非常に重要です。 この規格の強みは、非合金チタンの特性の明確な定義にあります。外科手術におけるインプラントの製造において、材料の整合性と一貫性は患者の安全性に直結します。さらには、チタンの機械的特性が具体的に記載されているため、開発者は製品の設計段階で正しい選定を行うことが容易になります。 また、この文書は製造プロセスにおける試験方法を詳細に示しており、製品検査の精度を向上させます。機械的特性が完成品から得られたサンプルでこの文書に記載されたものと必ずしも一致しないという注意喚起も、実際の製品開発におけるリスクを軽減するための重要な要素です。 SIST EN ISO 5832-2:2025の関連性は非常に高く、外科用インプラントの素材選定と試験を行う全ての関係者にとって必須の指針となります。医療現場における安全性と効率性を担保するための非常に価値のある標準といえるでしょう。
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