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MATERIAL QUALITY

ANALYSIS OF STAINLESS STEEL 316L

Chemical Composition of Low-Carbon Stainless Steel used in Manufacture of Surgical Implants.

Carbon 0.03 max.

Manganese 2.00 max.

Phosphorus 0.03 max.

Sulfur 0.03 max

Silicon 0.75 max

Chromium 17.00-20.00

Nickel 10.00 - 14.00

Molybdenum 2.00-4.00

Iron Balance

 

HISTORY OF ORTHOPAEDIC IMPLANTS

Archaeological evidences clearly indicates that surgical procedure were performed in several ancient civilizations. progress in surgery, however, was slow and mixed liberally superstition until the latter pan of the nineteenth century Scientist Pasteur's and Liter's antiseptic surgical techniques, developed around 1883. and shortly therefore Roentgen's discovery of X-rays in 1895. added a new dimension to Orthopaedic surgery. The great step forward in technique outstripped the stale of the material art.

In the beginning of the twentieth century, surgical technique were developed for the fixation of the bone fracture with the platc and screw combination. Shermen type bone plate were fabricated from the best available alloy at the time . Vanadium Steel. By the 1920s, use of Vanadium Steel Shermen plates became questionable, because of poor tissue compatibility. At the time however, no other alloy was available with high strength and good corrosion resistance properties.

Scientist shortly after the introduction of the 18-8 Stainless Steel, clinical experiments were conducted to utilizc the material for manufacture of surgical implants. This material had far- superior corrosion resistance to any thing that had been available up set that time and immediately attracted the interest of the Orthopaedic surgeons, Bone plate- Screw and other fixation appliances were fabricated and used as surgical implants, although the material performed better than anything else available it still showed some susceptibility to attack in the saline environment of the human body. In 1926 when Scientist Strauscs patentcd the 18-8 SMO stainless steel containing 2 to 4% molybdenum and a reduced carbon content of 0.08%. a material was created which promised improved resistance to acid and chloride containing environments. Result of research in 1930s were so encouraging that as a result the American Orthopaedic Committee of National Research Council assigned a research project to C.R Murray and C.G- Fink at Columbia University in 1941. The object of the project was to rapidly determine the most desirable metal or alloy for the internal fixation of fracture. Thc study resulted in recommendation of Type 316 stainless steel in 1943. Subsequent research at several medical centers across the nation prompted the American College of Surgeon at its 1946 meeting to endorse Type 316 and 316 L stainless steel for use in surgical implants.

During the 1960s the ASTM F-4 Sub-Committee was formed to standardizec materials used in surgical implant manufacture Currently available high-quality stainless steel arc now recommended for this application. The desirable properties of low carbon and vacuum or electrolyte remclted material have been recognized and standards covering these material have been published. Table summarizes the chemical requirement of these ASTM standards. Note that the alloy chemistry is identical to ASTM material standards so that both 316 and 316L grades may fit the specifications.

 

 

 

 

 

 


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