ISO 5832-11 covers wrought titanium 6-aluminium 7-niobium alloy used as metallic material for surgical implants.
This is a raw-material standard. Compliance with the material standard does not by itself constitute regulatory approval of a finished medical device.
What ISO 5832-11 Covers
- Wrought Ti-6Al-7Nb implant material.
- Material requirements defined by Part 11 of the ISO 5832 series.
Related Standards
- ISO 5832-2 for unalloyed titanium.
- ISO 5832-3 for wrought Ti-6Al-4V.
- The applicable medical-device design and regulatory requirements in addition to the raw-material standard.
Ordering and Certification
Identify the complete ISO standard and required edition, material form, dimensions, condition and certification requirements. For medical applications, the finished device must also meet all applicable design, manufacturing, validation and regulatory requirements.
Standards note: This page is a practical overview and is not a substitute for the official standard. Standards are revised periodically, and requirements can vary by edition, product form and application. Always state the required standard and revision on the purchase order and verify compliance against the applicable specification and material test report (MTR).
