What is ISO 5832-3 about?
ISO 5832-3 is one of a series of documents on Metallic materials for Implants for surgery that specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminum 4-vanadium alloy (Ti-6Al-4V alloy) for use in the manufacture of surgical implants.
ISO 5832-3 covers the raw material and not finished medical devices, where the design and fabrication of the device can impact biological response.
Note: The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with the specifications given in this document.
Who is ISO 5832-3 for?
ISO 5832-3 is useful for:
- Manufacturers of surgical implants
- Medical laboratories
- Surgical implants engineers and developers
Why should you use ISO 5832-3?
Surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body. It is considered to be a safe option for implants.
ISO 5832-3 helps you with characteristics of, and corresponding test methods for, the wrought titanium 6-aluminum 4-vanadium alloy (Ti-6Al-4V alloy) for use in the manufacture of surgical implants which helps in proper assessment and ensures the health and safety of patients.
Long-term clinical experience with the material referred to in ISO 5832-3 has shown that an acceptable level of biological response can be expected when the material is used inappropriate applications.
What’s changed since the last update?
BS EN ISO 5832-3:2021 supersedes ISO 58323:2016, which has been withdrawn. BS EN ISO 5832-3:2021 has some technical changes with respect to ISO 5832-3:2016, these include:
- Normative references have been updated
- Requirements for microstructure have been clarified in clause 5
- The pass/fail criteria for tensile testing of material properties have been clarified
- Table 3 on test methods has been updated
- References to ISO 20160 and EN 311403 have been removed