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Your needs: check that your materials for medical use comply with the ISO 5832 standard
What is the ISO 5832 standard?
First of all, a standard is a rule setting the conditions for the performance of an operation, the execution of an object or the elaboration of a product whose use is to be unified or interchangeable.
Thus, the ISO 5832 standard is a specific standard for metallic materials intended for medical use, in particular implants, prostheses and orthoses.
What are the specificities of the ISO 5832 standard
- The ISO 5832 standard is composed of several parts:
- ISO 5832-1: defines the characteristics applicable to stainless steel used in surgical implants. It also defines the corresponding test methods.
- ISO 5832-2: specifies the characteristics of unalloyed titanium used in the manufacture of surgical implants. It also defines the corresponding test methods.
- ISO 5832-3: Specifies the characteristics of wrought titanium-based alloy, known as titanium-aluminium-6-vanadium-4 alloy (Ti-6AI-4V alloy) for use in the manufacture of surgical implants. It also defines the corresponding test methods.
- ISO 5832-4: defines the characteristics and corresponding test methods of cobalt-chromium-molybdenum cast alloy used for the manufacture of surgical implants.
- ISO 5832-5: specifies the characteristics and corresponding test methods for wrought alloy based on cobalt, chromium, tungsten and nickel used for the manufacture of surgical implants.
- ISO 5832-6: defines the characteristics and corresponding test methods for wrought alloy based on cobalt, nickel, chromium and molybdenum, used to manufacture surgical implants.
- ISO 5832-7: defines the characteristics of cold-formed forging alloy based on cobalt, chromium, nickel, molybdenum and iron used to manufacture surgical implants. It also defines the corresponding test methods.
- ISO 5832-8: defines the characteristics of wrought alloy based on cobalt, nickel, chromium, molybdenum, tungsten and iron. It also defines the corresponding test methods.
- ISO 5832-9: specifies the characteristics of wrought stainless steels with a nitrogen content between 0.25% and 0.50%, used for the manufacture of surgical implants requiring high mechanical strength and corrosion resistance. It also defines the corresponding test methods.
- ISO 5832-10: defines the characteristics and corresponding test methods of wrought alloy based on titanium, aluminium 5 and iron 2.5 used to manufacture surgical implants.
- ISO 5832-11: defines the characteristics and corresponding test methods of the titanium wrought alloy known as titanium, aluminum-6 and niobium-7 (Ti – Al-6 – Nb-7) alloy used for the manufacture of surgical implants.
- ISO 5832-12: Specifies requirements for two wrought alloys based on cobalt 28, chromium 6 and molybdenum used for surgical implants. The characteristics are specifically applicable to bars, wire rods and wrought wires.
- ISO 5832-13: defines the characteristics and corresponding test methods of wrought titanium, niobium and zirconium based alloy used to manufacture surgical implants.
- ISO 5832-14: specifies the characteristics and corresponding test methods of wrought alloy based on titanium, molybdenum-15, zirconium-5 and aluminum-3 used for the manufacture of surgical implants.
FILAB laboratory assists you in the analysis of materials intended for medical use according to the ISO 5832 standard
FILAB, a laboratory made up of experts in the analysis of materials intended for medical use, offers you its analytical services, from the design to the manufacture and implementation of a product meeting the ISO 5832 standard.
The filab advantages
A highly qualified team
Responsiveness in responding to and processing requests
A COFRAC ISO 17025 accredited laboratory
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
A complete analytical park of 5,200m²
Tailor-made support
