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By their very nature, devices intended for medical use must meet extremely stringent design and manufacturing standards. In a world increasingly preoccupied with litigation and retribution for bodily injury or damage caused by medical error, anything that touches or is surgically implanted into the human body must function exactly as intended and must not fail. .
The process of designing and manufacturing medical devices is one of the most complex materials science and engineering problems to be solved in the medical industry. With such a wide range of applications, medical devices come in all shapes and sizes to perform a wide variety of tasks, so scientists and engineers use a variety of materials to meet the most stringent design requirements.
Stainless steel is one of the most commonly used materials in medical device manufacturing, especially 304 stainless steel.
304 stainless steel 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 offers such a variety of shapes, finishes and applications. The properties of 304 stainless steel offer unique material properties at a competitive price, making them the logical choice for medical equipment specifications.
High corrosion resistance and low carbon content are key factors that make 304 stainless steel more suitable for medical applications than other grades of stainless steel. Medical devices do not chemically react with body tissue, the cleaning agents used to sterilize them, and the hard, repetitive wear and tear that many medical devices are subject to, meaning Type 304 stainless steel is an ideal material for hospital, surgical, and paramedical applications. applications. , among others.
304 stainless steel is not only strong but also extremely easy to process and can be deep drawn without annealing, making 304 ideal for making bowls, sinks, pots and a range of different medical containers and hollow items.
There are also many different versions of 304 stainless steel with improved material properties for specific applications, such as a heavy duty low carbon version of 304L where high strength welds are required. Medical equipment may use 304L where welding must withstand a series of shocks, continuous stress and/or deformation, etc. 304L stainless steel is also a low temperature steel, which means it can be used in applications where the product must operate at extremely low temperatures. temperatures. For extremely corrosive environments, 304L also provides greater resistance to intergranular corrosion than comparable stainless steel grades.
The combination of low yield strength and high elongation potential means that Type 304 stainless steel is well suited for forming complex shapes without annealing.
If a harder or stronger stainless steel is required for medical applications, 304 can be hardened by cold working. When annealed, 304 and 304L steels are extremely ductile and can be easily formed, bent, deep drawn or fabricated. However, 304 hardens quickly and may require further annealing to improve ductility for further processing.
304 stainless steel is widely used in various industrial and domestic applications. In the medical device industry, 304 is used where high corrosion resistance, good formability, strength, precision, reliability and hygiene are of particular importance.
For surgical stainless steels, special grades of stainless steel, 316 and 316L, are mainly used. With alloying elements of chromium, nickel and molybdenum, stainless steel offers materials scientists and surgeons unique and reliable qualities.
Warning. It is known that in rare cases the human immune system reacts negatively (cutaneously and systemically) to the nickel content in some stainless steels. In this case, titanium can be used instead of stainless steel. However, Titanium offers a more expensive solution. Typically, stainless steel is used for temporary implants, while more expensive titanium may be used for permanent implants.
For example, the table below lists some possible applications for stainless steel medical devices:
The views expressed here are those of the authors and do not necessarily reflect the views and opinions of AZoM.com.
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