The ISO 5832 standard, developed by the International Organization for Standardization (ISO), consists of the following sub-sections under the main heading "Surgical implants - Metallic materials":
The ISO 5832-1 standard describes the properties of wrought stainless steel used in the manufacture of surgical implants and defines the corresponding test methods. The mechanical properties of a sample obtained from a finished product made of this alloy may differ from those specified in this standard. The alloy described in this section corresponds to the alloy code in the ASTM F138 and ASTM F139 standards. For the purposes of this standard, the original gauge length refers to the length between the gauge length marks on the test piece measured at room temperature prior to testing.
In the ISO 5832-2 standard, the properties of unalloyed titanium used in the production of surgical implants are described and the corresponding test methods are defined. The six titanium grades based on tensile strength are listed in table 2 within the standard. The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with the specifications specified in this standard.
In the ISO 5832-3 standard, the properties of the forged titanium alloy known as the titanium 6-aluminum 4-vanadium alloy (Ti 6-AI4-V alloy) used in the production of surgical implants are described and the corresponding test methods are defined. The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily conform to the specifications set forth in this standard.
In the ISO 5832-4 standard, the properties of the cobalt-chromium-molybdenum casting alloy used in the production of surgical implants are described and the corresponding test methods are defined.
ISO 5832-5 describes the properties of wrought cobalt-chromium-tungsten-nickel alloy used in the production of surgical implants and defines the corresponding test methods. The tensile properties of a sample obtained from a finished product made of this alloy may not necessarily conform to the specifications stated in this standard.
In the ISO 5832-6 standard, the properties of the forged cobalt-nickel-chromium-molybdenum alloy used in the production of surgical implants are described and the corresponding test methods are defined. The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily conform to the specifications set forth in this standard.
The ISO 5832-7 standard describes the properties of malleable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy used in the production of surgical implants and defines the corresponding test methods.
In the ISO 5832-8 standard, the properties of the wrought cobalt-nickelchrome-molybdenum-tungsten-iron alloy used in the production of surgical implants are described and the corresponding test methods are defined. The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily conform to the specifications set forth in this standard.
The ISO 5832-9 standard describes the properties of forged stainless steel containing 0,25 to 0,50 percent nitrogen by mass, used in the manufacture of surgical implants where high durability and corrosion resistance are required, and defines the corresponding test methods. The mechanical properties of a sample obtained from a finished product made of this alloy may differ from those specified in this standard. Requirements for other stainless steels for surgical implants are contained in the ISO 5832-1 standard.
The ISO 5832-10 standard describes the properties of forged high-nitrogen stainless steel used in the manufacture of surgical implants and defines the corresponding test methods. The mechanical properties of a sample obtained from a finished product made of this alloy may differ from those specified in this standard.
The ISO 5832-11 standard describes the properties of wrought titanium alloy, known as titanium-6-aluminum-7-niobium alloy (Ti-6-Al7-Nb), used in the production of surgical implants, and defines the corresponding test methods.
The ISO 5832-12 standard describes the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgical implants. The specifications are especially applicable to forged rod, rod and wire. The mechanical properties of a sample obtained from a finished product made of this alloy may differ from those specified in this standard. The high carbon content of this alloy creates a structure with a significant carbide distribution. This can be adjusted either in the manufacture of the bar or in subsequent thermomechanical processing to produce the final device. The carbide distribution in the final device is not included as part of this standard.
In the ISO 5832-14 standard, the properties of the forged titanium 15-molybdenum 5-zirconium 3-aluminum alloy used in the production of surgical implants are described and the corresponding test methods are defined. This standard applies to rod-shaped materials up to a maximum diameter of 100 mm. The mechanical properties of a sample obtained from a finished product made of this alloy may differ from those specified in this standard.
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