ISO 5832-2-2018 PDF

Full title and description

ISO 5832-2:2018 — 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; it defines grades based on tensile strength and related material requirements for implant manufacture.

Abstract

ISO 5832-2:2018 sets out material characteristics and test methods for unalloyed titanium used in surgical implants, including the designation of six tensile-strength-based grades and a note that mechanical properties measured on finished products may differ from those given in the standard.

General information

• Status: Withdrawn (replaced by a later edition published in 2025; withdrawal recorded in national repositories October 1, 2025).
• Publication date: March 2018 (Edition 4 — published March 2018; commonly listed with publication dates in March–May 2018 in national adopters).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: 4 (fourth edition, 2018).
• Number of pages: 3 (core ISO document is a short, 3‑page publication).

Scope

Specifies the characteristics of, and corresponding test methods for, unalloyed titanium intended for use in the manufacture of surgical implants. The standard lists six grades of titanium classified by tensile strength and provides requirements and test methods applicable to bar, wire and other product forms used for implants; it also notes that mechanical properties of finished products can differ from those specified for the raw material.

Key topics and requirements

• Definition of unalloyed titanium for surgical implants and permitted product forms.
• Designation of six material grades based on tensile strength (values and grade table included in the standard).
• Required mechanical-property testing (tensile tests) and associated acceptance criteria for each grade.
• Notes on sampling, test-piece preparation and the advisory statement that finished-product properties may not match raw‑material values.
• Application-focused requirements intended to support safe use of titanium in implantable medical devices.

Typical use and users

Used by medical‑device manufacturers, materials suppliers, implant designers, quality and regulatory teams, and independent testing laboratories to specify and verify implant-grade unalloyed titanium for orthopaedic, dental and other surgical implants. Regulatory reviewers and conformity-assessment bodies also reference the standard when evaluating metallic implant components.

Related standards

Part of the ISO 5832 series (Implants for surgery — Metallic materials). Related parts include ISO 5832-1 (stainless steel), ISO 5832-3 (Ti-6Al-4V), ISO 5832-4 (Co-Cr-Mo casting alloys), and additional parts covering other titanium and cobalt/chrome alloys used for implants; users commonly consult adjacent parts of the 5832 series for material selection and cross-referencing.

Keywords

unalloyed titanium, surgical implants, implant materials, metallic materials, tensile strength grades, ISO 5832, implant testing, medical device materials.

FAQ

Q: What is this standard?

A: ISO 5832-2:2018 is an ISO International Standard titled "Implants for surgery — Metallic materials — Part 2: Unalloyed titanium" that defines material characteristics and test methods for titanium used in surgical implants.

Q: What does it cover?

A: It covers material composition and mechanical characteristics for unalloyed titanium intended for implants, specifies tensile-strength-based grades (six grades), and gives corresponding test methods and acceptance criteria; it also notes that finished-product properties may differ from the raw-material values.

Q: Who typically uses it?

A: Implant manufacturers, material suppliers, test laboratories, regulatory and quality professionals in the medical-device sector, and standards committees involved in implant materials.

Q: Is it current or superseded?

A: ISO 5832-2:2018 has been withdrawn and superseded by a later edition published in 2025; national repositories record withdrawal (for example, withdrawal noted 1 October 2025 in some catalogs). Users should consult the 2025 edition (ISO 5832-2:2025) or the current national/adopted version for up-to-date requirements.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 5832 series, which covers metallic materials for surgical implants (other parts address stainless steels, titanium alloys, cobalt‑chromium alloys and related implant materials).

Q: What are the key keywords?

A: Unalloyed titanium; implant-grade titanium; tensile strength grades; surgical implants; metallic implant materials; ISO 5832.