ISO 5832-2-2025 PDF

Full title and description

ISO 5832-2:2025 — Implants for surgery — Metallic materials — Part 2: Unalloyed titanium. This International Standard specifies the required characteristics and corresponding test methods for unalloyed titanium intended for the manufacture of surgical implants, and lists six grades of titanium defined by tensile strength.

Abstract

This document defines material composition and mechanical property requirements and gives the associated test methods for unalloyed titanium used in surgical implants. It lists six grades of titanium based on tensile strength and notes that mechanical properties measured on finished products may not necessarily match the values specified for the raw material.

General information

• Status: Published.
• Publication date: 4 September 2025 (ISO publication stage: International Standard published 2025-09-04).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 5 (2025).
• Number of pages: 4.

Scope

ISO 5832-2:2025 applies to unalloyed titanium intended for the manufacture of surgical implants. It specifies the material characteristics and the corresponding test methods required to demonstrate that supplied material meets the defined grades and property limits. The standard is aimed at ensuring consistent quality of implant-grade unalloyed titanium across supply chains.

Key topics and requirements

• Definition of six grades of unalloyed titanium based on tensile strength and associated property limits.
• Requirements for chemical composition and permissible impurities for implant-grade titanium.
• Specified mechanical tests and test methods (tensile testing, determination of tensile strength, yield, elongation; referenced methods for hardness and other relevant mechanical characterisation).
• Sampling and test-piece production requirements to ensure results are representative of supplied material.
• Notes on finished-product variation: mechanical properties measured on finished implants may differ from properties of the raw material specified in the standard.

Typical use and users

Manufacturers of surgical implants (orthopaedic, dental and other internal implants), medical device material suppliers, quality and testing laboratories, conformity and regulatory bodies, procurement specialists in healthcare, and design engineers who select implant materials. Laboratories performing acceptance testing and certification bodies use the standard to assess raw-material compliance for implant production.

Related standards

ISO 5832 is a multipart series covering metallic materials for surgical implants (for example: Part 1 — wrought stainless steel; Part 3 — Ti-6Al-4V; Part 4 — CoCrMo casting alloy; Parts 5–9 and others cover various cobalt‑chromium and stainless steel alloys). ISO 5832-2:2025 revises and replaces the previous ISO 5832-2 edition. For a complete series listing and cross-references see the ISO 5832 series entries.

Keywords

unalloyed titanium, implants for surgery, implant-grade titanium, tensile strength grades, material test methods, ISO 5832, surgical implants, biomaterials, implant materials

FAQ

Q: What is this standard?

A: ISO 5832-2:2025 is an international standard that specifies the characteristics and test methods for unalloyed titanium used in the manufacture of surgical implants.

Q: What does it cover?

A: It covers required material characteristics, grading by tensile strength (six grades), and the corresponding test methods and sampling requirements to verify that supplied unalloyed titanium meets implant-grade criteria. The standard also notes that finished-product properties may differ from raw-material values.

Q: Who typically uses it?

A: Implant manufacturers, material suppliers, testing laboratories, regulatory and conformity assessment bodies, and engineers specifying materials for surgical devices.

Q: Is it current or superseded?

A: ISO 5832-2:2025 is the current published edition (Edition 5, published 4 September 2025). It supersedes the previous edition(s), including ISO 5832-2:2018.

Q: Is it part of a series?

A: Yes — ISO 5832 is a multipart series (Implants for surgery — Metallic materials) with individual parts for different metallic implant materials (Parts 1, 2, 3, 4, etc.). ISO 5832-2 is Part 2 (unalloyed titanium) of that series.

Q: What are the key keywords?

A: Unalloyed titanium; implant-grade titanium; tensile strength grades; material test methods; surgical implants; ISO 5832; biomaterials.