ISO 5832-2 specifies the properties and corresponding test methods of unalloyed titanium for use in the manufacture of surgical implants.
If any of the test pieces fails within the size limits and does not meet the specified requirements, the two retest pieces shall be tested in the same way for each failed test piece. The alloy will be considered suitable only if both additional test pieces meet the specified requirements.
If a test piece fails outside of the gauge limits, the test is acceptable if the percent elongation after fracture meets the requirements. If the percent elongation after fracture does not meet the requirements, the test will be canceled and retested.
If any of the retests fail to meet the appropriate requirements, the product represented will be considered non-compliant with this document. However, if desired, the manufacturer may heat-treat the material again and resubmit it for testing in accordance with this document.
No known surgical implant material has been shown to cause absolutely any adverse reactions in the human body. However, long-term clinical experience with the use of material referred to in this standard has shown that an acceptable level of biological response can be expected when the material is used in appropriate applications.
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