ISO 5832-2-2018 pdf download.Implants for surgery – Metallic material ls – 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.
2 Normative references
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
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http//www.electropedia.orgJ
— ISO Online browsing platform: available at https://www.iso.org/obp
4 Chemical composition
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.
5 Microstructure
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 x 100, no inclusions or foreign phases 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.
6 Mechanical properties
6.1 Tensile 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.
6.2 Bending properties
Titanium sheet and strip, when tested as specified in Clause 7. shall not show any cracking on the outside surface of the test piece.ISO 5832-2 pdf download.
Tags: Implants for surgery
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