Chemical Characteristics – Stainless Steel (304)
The material used for the manufacturing of liposuction cannula tubes is AISI 304. It is an invasive part and
makes direct contact with the patient’s body. In addition the device is used for to administer or readminister
medical products and body fluids.
The key chemical characteristics that are checked to verify the grade of stainless steel 304 are;
8 Elements Acceptable
Significance
of the Test Parameters
Steel alloys composed with a minimum of 10.5% chromium fall into the
Chromium stainless category. The chromium content attributes particular qualities to the
18% - 20%
(Cr) steel, including exceptional corrosion resistance. This quality is what gives
stainless its rust-free status.
Carbon is the most important commercial steel alloy. Increasing carbon content Less than or
Carbon increases hardness and strength and improves hardenability. But carbon also equal to
(C) increases brittleness and reduces weldability because of its tendency to form
martensite. 0.08 %
Magnesium is used in alloys because it is a light metal, which improves the Less than or
Magnesium
mechanical properties of steels. At the same time, the strength and hardness equal to
(Mn) also increase, while the relative elongation and impact toughness decrease. 2.00 %
Phosphorus is usually added with Sulphur, to improve machinability. The
Phosphorus Less than or
Phosphorus present in Austenitic stainless steels increases strength. However,
equal to
(P) it has a detrimental effect on corrosion resistance and increases the tendency
0.045 %
of the material to crack during welding.
Sulfur is usually an undesirable impurity in steel rather than an alloying
Sulphur Less than or
element. In amounts exceeding 0.05% it tends to cause brittleness and reduce
equal to
(S) weldability. Alloying additions of sulfur in amounts from 0.10% to 0.30% will
0.030 %
tend to improve the machinability of a steel.
Silicon Silicon also improves oxidation resistance and is a “ferrite” stabilizer. In Less than or
“austenitic stainless steels, high silicon contents improves resistance to equal to <
(Si) oxidation and also prevents carburizing at elevated temperatures. 1.00 %
Nickel As an alloying element, nickel enhances its important properties such as
formability, weldability and ductility, while increasing corrosion resistance in 8 % - 10 %
(Ni) certain applications.
Cobalt has been used for many years to create alloys to improve the wear and
corrosion resistance of steel. The presence of cobalt in stainless steel is
significant for its strength and corrosion resistance.
Cobalt
Cobalt is often present in stainless steel, usually at about 0.25%. Cobalt is on 0% - 0.40%
(Co)
the list of CMR substances, so must be declared on the label of the medical
device if it is in excess of 0.1% w/w to meet the Annex I GSPR 10.4.1
requirement.
It is important to note that these parameters serve as general guidelines for the chemical composition of Stainless
Steel 304 rather than absolute values. Slight variations are expected within acceptable industry tolerances, as
long as the material is verified to be AISI 304.