EN ISO 5832-2:2025 PDF

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 (