SIST EN 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
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• 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
• Ref Project: EN ISO 5832-2:2025 - Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2025)

Relations

• Replaces: SIST EN ISO 5832-2:2018 - Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)
• Effective Date: 01-Nov-2025
• Refers: oSIST prEN 13383-2:2021 - Armourstone - Part 2: Complementary information and test methods
• Effective Date: 28-Jan-2026
• Refers: SIST EN 15425:2023/oprA1:2025 - Adhesives - One component polyurethane (PUR) for load-bearing timber structures - Classification and performance requirements
• Effective Date: 28-Jan-2026

Overview

SIST EN ISO 5832-2:2025 establishes the requirements and testing methods for unalloyed titanium intended for use in the manufacturing of surgical implants. This European and international standard is developed by ISO and adopted by the Slovenian Institute for Standardization (SIST), ensuring harmonization across countries for safe and effective medical devices. The standard covers six grades of unalloyed titanium, defined primarily by their tensile strength and composition, and provides guidelines to assure material quality, mechanical properties, and appropriate testing protocols.

Key Topics

• Material Specification: Defines the chemical composition limits for unalloyed titanium, including elements such as nitrogen, carbon, hydrogen, iron, oxygen, and cobalt, with titanium as the balance.
• Grades of Titanium: Lists six distinct grades of unalloyed titanium, classified according to minimum tensile strength, proof (yield) strength, reduction of area, and elongation properties.
• Microstructure Requirements: Specifies uniform microstructure, grain size (no coarser than No. 5), and absence of foreign phases or inclusions, ensuring material reliability.
• Mechanical Properties: Outlines minimum requirements for tensile strength, yield strength, elongation after fracture, and bending properties, tailored to the intended surgical application.
• Test Methods: Mandates recognized analytical procedures in accordance with internationally validated methods (e.g., ISO 6892-1 for tensile testing, ISO 643/ASTM E112 for grain size determination, and ISO 7438 for bend testing).
• Quality Assurance: Stipulates rigorous retesting and conformance conditions, emphasizing consistency and reliability for implant manufacturing.

Applications

• Orthopedic Implants: Used as a reference for raw material selection in joint replacements, fracture fixation devices, and spinal implants due to titanium's high biocompatibility and corrosion resistance.
• Dental Implants: Ensures that titanium used in dental applications meets strict compositional and mechanical criteria for safe, long-lasting integration.
• Prosthetic Devices: Provides guidance for manufacturers of various implantable devices, where the material's physical properties and reliability are critical.
• Medical Device Manufacturing: Supports quality management systems and conformity assessment procedures for medical device manufacturers, helping to meet international regulatory requirements.

The standard is relevant throughout the supply chain, from material suppliers to finished product manufacturers, facilitating traceability, consistency, and compliance in the European and global healthcare industries.

Related Standards

• ISO 5832 Series: SIST EN ISO 5832-2:2025 is part of the wider ISO 5832 series, which covers various metallic materials for surgical implants, including stainless steels and titanium alloys.
• ISO 6892-1: Standard method for tensile testing of metallic materials at room temperature, referenced for mechanical property evaluation.
• ISO 643 / ASTM E112: Used for determining the grain size of steels and titanium, ensuring microstructural control.
• ISO 7438: Specifies the bend test for metallic materials, assessing ductility and forming properties.
• ASTM F67: Provides technical guidance for unalloyed titanium used in surgical implant applications.
• Regulatory Requirements: Supports compliance with European Medical Device Regulation (MDR), harmonized standards, and other country-specific regulations for implants.

Adorning a rigorous approach to material specification and testing, SIST EN ISO 5832-2:2025 is a critical reference for anyone involved in the design, manufacturing, or regulatory compliance of titanium surgical implants. By adhering to this standard, organizations assure product safety, quality, and international acceptability in the rapidly evolving medical device sector.

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
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
...