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881 TENSILE STRENGTH
Devices for measurement of tensile strength used in the United States may be calibrated in the English units of measure. The following directions are given in metric units with the understanding that the corresponding English equivalents may be used.

Surgical Suture
Determine the tensile strength of surgical suture on a motor-driven tensile strength testing machine having suitable clamps for holding the specimen firmly and using either the principle of constant rate of load on specimen or the principle of constant rate of elongation of specimen, as described below. The apparatus has two clamps for holding the strand. One of these clamps is mobile. The clamps are designed so that the strand being tested can be attached without any possibility of slipping. Gauge length is defined as the interior distance between the two clamps. For gauge lengths of 125 to 200 mm, the mobile clamp is driven at a constant rate of elongation of 30 ± 5 cm per minute. For gauge lengths of less than 125 mm, the rate of elongation per minute is adjusted to equal 2 times the gauge length per minute. For example, a 5-cm gauge length has a rate of elongation of 10 cm per minute.
Determine the tensile strength of the suture, whether packaged in dry form or in fluid, promptly after removal from the container, without prior drying or conditioning. Attach one end of the suture to the clamp at the load end of the machine, pass the other end through the opposite clamp, applying sufficient tension so that the specimen is taut between the clamps, and engage the second clamp. Perform as many breaks as are specified in the individual monograph. If the break occurs at the clamp, discard the reading on the specimen.
Procedure for a machine operating on the principle of constant rate of load on specimen— This description applies to the machine known as the Incline Plane Tester.
The carriage used in any test is of a weight such that when the break occurs, the position of the recording pen on the chart is between 20% and 80% of the capacity that may be recorded on the chart. The friction in the carriage is low enough to permit the recording pen to depart from the zero line of the chart at a point not exceeding 2.5% of the capacity of the chart when no specimen is held in the clamps.
For surgical sutures of intermediate and larger sizes, the clamp for holding the specimen is of the roll type, with a flat gripping surface. The roll has a diameter of 19 mm and the flat gripping surface is not less than 25 mm in length. The length of the specimen, when inserted in the clamps, is at least 127 mm from nip to nip. The speed of inclination of the plane of the tester is such that it reaches its full inclination of 30 from the horizontal in 20 ± 1 seconds from the start of the test.
For surgical sutures of small sizes, the suitable clamp has a flat gripping surface of not less than 13 mm in length. The speed of inclination of the plane is such that it reaches its full inclination of 30 from the horizontal in 60 ± 5 seconds from the start of the test.
Except where straight pull (no knot required) is indicated in the suture monograph, tie the test suture into a surgeon's knot with one turn of suture around flexible rubber tubing of 6.5-mm inside diameter and 1.6-mm wall thickness. The surgeon's knot is a square knot in which the free end is first passed twice, instead of once, through the loop, and pulled taut, then passed once through a second loop, and the ends are drawn taut so that a single throw is superimposed upon a double throw. Start the first knot with the left end over the right end, exerting sufficient tension to tie the knot securely. Where the test specimen includes a knot, place the specimen in the testing device with the knot approximately midway between the clamps. Leave the flexible rubber tubing in place for the duration of the test.
Procedure for a machine operating on the principle of constant rate of elongation of specimen— This description applies to any suitable tensile testing machine that operates on the principle of constant rate of elongation of specimen.
Except where straight pull (no knot required) is indicated in the suture monographs, tie the test suture into a simple knot formed by placing one end of a strand held in the right hand over the other end held in the left hand, passing one end over the strand and through the loop so formed, and pulling the knot tight. The specimen is placed in the testing device with the knot approximately midway between the clamps.

Textile Fabrics and Films
Determine the tensile strength of textile fabrics, including adhesive tape, on a constant-speed or pendulum type of testing machine of the following general description.
The clamps for holding the specimen are smooth, flat, parallel jaws that are not less than 25 mm in length in the dimension parallel to the direction of application of the load. When the width of the strip being tested does not exceed 19 mm, the jaws of the clamp should be at least 25 mm wide. If the width of the strip is greater than 19 mm and not greater than 44 mm, the width of the jaws of the clamp should be at least 50 mm. If the width of the specimen is greater than 44 mm, cut a 25-mm strip, and use a clamp with jaws not less than 50 mm wide. Round all edges that might have a cutting action on the specimen to a radius of 0.4 mm. The jaws are 76.2 mm apart at the beginning of the test, and they separate at the rate of 30.5 cm ± 13 mm per minute. The machine is of such capacity that when the break occurs, the deviation of the pendulum from the vertical is between 9 and 45.

Auxiliary Information—
Staff Liaison : Radhakrishna S Tirumalai, Scientist
Expert Committee : (GTMDB05) General Toxicology and Medical Device Biocompatibility
USP29–NF24 Page 2776
Phone Number : 1-301-816-8339