ISO/DIS 5832-2:2025(en)

ISO/TC 150/SC 1/WG 3

Secretariat: DIN

Date: 2025-12-14

Implants for surgery — Metallic materials —

Part 2: Unalloyed titanium

© ISO 2025

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Contents

Foreword iv

Introduction v

1 Scope 1

2 Normative references 1

3 Terms and definitions 1

4 Clause title 1

5 Microstructure 2

6 Mechanical properties 2

6.1 Tensile properties 2

6.2 Bending properties 2

7 Test methods 3

Bibliography 5

Foreword

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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 documents 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).

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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, SC 1, Materials.

This fifth edition cancels and replaces the fourth edition (ISO 5832-2:2018), which has been technically revised.

The main changes are as follows:

— the introduction has been updated;

— normative references have been updated;

— the requirement for cobalt in Table 1 has been added;

— the wording for mechanical properties in Table 2 has been updated;

— this document has been harmonized with the ISO 5832 series.

A list of all parts in the ISO 5832 series can be found on the ISO website.

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.

Introduction

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 part of ISO 5832 has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications. However, this standard covers the raw material and not finished medical devices, where the design and fabrication of the device can impact biological response.

Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

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 comply with those specified in this document.

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.

ISO 643, Steels — Micrographic determination of the apparent grain size

ISO 6892‑1, Metallic materials — Tensile testing — Part 1: Method of test at room temperature

ISO 7438, Metallic materials — Bend test

ASTM E112, Standard test methods for determining average grain size

No terms and definitions are listed in this document.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp

— IEC Electropedia: available at https://www.electropedia.org/

The heat analysis when determined as specified in Clause 7 shall conform to the requirements as to chemical composition specified in Table 1. Ingot analysis may be used for reporting all chemical requirements except hydrogen, which shall be determined after the last heat treatment and pickling procedure.

Table 1 — Chemical composition

The microscopic structure of the titanium in the annealed condition shall be uniform. The grain size, determined as specified in Clause 7, shall be no coarser than grain size No. 5.

At a magnification of ×100, no inclusions or foreign phases shall be visible. At a magnification of ×100, no continuous layer of alpha case shall be visible.

Iron is a beta phase stabilizer and the allowable iron limits might be sufficient to retain beta phase which is not considered a foreign phase in the microstructure. Mechanical properties

The tensile properties of the titanium, determined as specified in Clause 7, shall be in accordance with the requirements of Table 2.

If any of the test pieces fail within the gauge limits and do not meet specified requirements, two retest pieces shall be tested in the same manner, for each failed test piece. The alloy shall be deemed to comply only if both additional test pieces meet the specified requirements.

If a test piece fails outside the gauge limits, the test is acceptable if the percentage elongation after fracture meets the requirements. If the percentage elongation after fracture does not meet requirements the test shall be discarded and a retest shall be performed.

If any of the retests fails to meet the appropriate requirements, the product represented shall be deemed not to comply with this document. However, the manufacturer may, if desired, subject the material to heat treatment again and resubmit it for testing in accordance with this document.

Titanium sheet and strip, when tested as specified in Clause 7, shall not show any cracking on the outside surface of the test piece.

Table 2 — Mechanical properties

The test methods to be used in determining conformity to the requirements of this document shall be those given in Table 3.

Representative test pieces for the determination of mechanical properties shall be prepared in accordance with the provisions of ISO 6892‑1.

Table 3 — Methods of test