The ISO 5832 series specifies metals and alloys used for surgical implants. Now two of the parts have been updated, ISO 5832-4 and ISO 5832-11. They cover cobalt-chromium-molybdenum casting alloy and wrought titanium 6-aluminium 7-niobium alloy respectively. The standards were developed to provide parameters for achieving an acceptable level of biological response for products using these materials. Let’s review these new revisions one at a time:
ISO 5832-4, 3rd Edition, Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum casting alloy
This standard specifies the characteristics of and test methods for cobalt-chromium-molybdenum casting alloys for surgical implants. Table 1 provides you with the elemental constituents of the alloy. Table 2 covers the mechanical properties required. And Table 3 is a listing of the test methods necessary (from ISO 6802-1). Corresponding sections 3, 4, and 5 provide the context for usage. The obsolete 2nd Edition was released in 1996, so it’s been a while since the document has been changed.
ISO 5832-11, 2nd Edition, Implants for surgery – Metallic materials – Part 11: Wrought titanium 6-aluminium 7-niobium alloy
The layout and rationale for the standard are similar to that of the Part 4. However there is an additional section on microstructure that’s been inserted after the elemental composition clause. This references ISO 20160, for annealed material. And again, it’s been some time since the document has been revised, since the now-obsolete 1st Edition was released in 1994.
The complete series is comprised of 12 parts, on the following metals and alloys:
- Part 1: Wrought stainless steel
- Part 2: Unalloyed titanium
- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
- Part 4: Cobalt-chromium-molybdenum casting alloy
- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
- Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
- Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy
- Part 9: Wrought high nitrogen stainless steel
- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
- Part 12: Wrought cobalt-chromium-molybdenum alloy
- Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy
If you use these alloys in your surgical implants, you’ll want to get copies of the new editions. Go to the Document Center webstore at www.document-center.com and order them there. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ll be able to assist you with your purchase as well as offer you additional products and services that will help you maintain your collection of conformance documentation. We’ve been selling standards from our Silicon Valley location since 1982 and have been on the web since 1993. Make us your Standards Experts!