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By their very nature, devices designed for medical use must meet extremely stringent design and manufacturing standards.In a world of lawsuits and retribution claims for injury or damage caused by medical malpractice, anything that touches or is surgically implanted in the human body must function exactly as designed and must not fail.
The design and manufacturing process of medical devices presents some of the most challenging materials science and engineering problems for the medical industry.With such a wide range of applications, medical devices come in all shapes and sizes to perform many different jobs, so scientists and engineers use a variety of materials to help meet the most stringent design specifications.
Stainless steel is one of the most commonly used materials for the manufacture of medical devices, especially stainless steel 304.
Stainless steel 304 is recognized worldwide as one of the most suitable materials for the manufacture of medical devices for various applications.In fact, it is the most commonly used stainless steel in the world today.No other grade of stainless steel comes in so many forms, finishes and so many diverse applications.Stainless Steel 304 Properties offer unique material properties at a competitive price, thus making it a logical choice for medical device specifications.
High corrosion resistance and low carbon content are key factors that make 304 stainless steel suitable for medical applications over other grades of stainless steel.The assurance that medical devices will not chemically react with body tissue, the cleaning products used for disinfection, and the tough, repetitive wear and tear that many medical devices experience means that stainless steel 304 is the perfect material for hospital, surgical and paramedic applications, and more.
Not only is stainless steel 304 strong, it is also very practical and can be deep drawn without annealing, making 304 ideal for making bowls, sinks, pans and a range of different medical containers and hollowware.
There are also many different versions of stainless steel 304 with improved material properties for specific applications, such as 304L, a low carbon version, for heavy gauge situations that require high strength welds.Medical devices may contain 304L where welding is required to withstand a range of shocks, prolonged stress and/or strain, etc.Stainless Steel 304L is also a low temperature steel, which means it can be used in applications that require the product to operate in extremely cold temperatures.For extremely corrosive environments, 304L is also more resistant to intergranular corrosion than comparable grades of stainless steel.
The combination of low yield strength and high elongation potential means 304 stainless steel is ideal for forming into complex shapes without the need for annealing.
If medical applications require a harder or stronger stainless steel, 304 can be work hardened by cold working.In the annealed condition, 304 and 304L are extremely ductile and can be easily formed, bent, deep drawn or fabricated.However, 304 does harden rapidly and may require further annealing to increase ductility for further work.
304 stainless steel is widely used in a variety of industrial and domestic applications.In the medical device industry, 304 is used where high corrosion resistance, good formability, strength, manufacturing accuracy, reliability and hygiene are particularly important.
For surgical stainless steels, specific grades of stainless steel are mainly used – 316 and 316L.By alloying the elements chromium, nickel and molybdenum, stainless steel offers materials scientists and surgeons some unique and reliable qualities.
Caution – In rare cases, the human immune system is known to react adversely (skin and whole body) to the nickel content in some stainless steels.In this case, titanium can be used as a substitute for stainless steel.However, Titanium brings a more expensive solution.Typically, stainless steel is used for temporary implants, while the more expensive titanium can be used for permanent implants.
For example, the following list summarizes some possible medical device applications for stainless steel:
The views expressed here are those of the author and do not necessarily reflect the views and opinions of AZoM.com.
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