Procedure—
Clamp each of 5sutures in the tensilometer so that the needle is in the fixed clamp with all of the swaged portion exposed and in line with the direction of force applied to the suture by the moving clamp.Determine the force required to detach the suture from the needle.In the case of
Standard Needle Attachment,the suture may break without needle detachment.
Standard Needle Attachment—
The requirements are met if neither the average of the 5values nor any individual value is less than the limit given for the designated size in
Table 1.
Table 1.Standard Needle Attachment for Absorbable and Nonabsorbable Sutures
| Metric Size (Gauge No.) |
Limits on Needle Attachment |
| Absorbable Collagen Suture |
Nonabsorbable and Synthetic Absorbable Sutures |
USP Size |
Average (in kgf)(Min.) |
Individual (in kgf)(Min.) |
Average (in N)(Min.) |
Individual (in N)(Min.) |
|
0.1 |
11-0 |
0.007 |
0.005 |
0.069 |
0.049 |
|
0.2 |
10-0 |
0.014 |
0.010 |
0.137 |
0.098 |
| 0.4 |
0.3 |
9-0 |
0.021 |
0.015 |
0.206 |
0.147 |
| 0.5 |
0.4 |
8-0 |
0.050 |
0.025 |
0.490 |
0.245 |
| 0.7 |
0.5 |
7-0 |
0.080 |
0.040 |
0.784 |
0.392 |
| 1 |
0.7 |
6-0 |
0.17 |
0.08 |
1.67 |
0.784 |
| 1.5 |
1 |
5-0 |
0.23 |
0.11 |
2.25 |
1.08 |
| 2 |
1.5 |
4-0 |
0.45 |
0.23 |
4.41 |
2.25 |
| 3 |
2 |
3-0 |
0.68 |
0.34 |
6.67 |
3.33 |
| 3.5 |
3 |
2-0 |
1.10 |
0.45 |
10.8 |
4.41 |
| 4 |
3.5 |
0 |
1.50 |
0.45 |
14.7 |
4.41 |
| 5 |
4 |
1 |
1.80 |
0.60 |
17.6 |
5.88 |
| 6and larger |
5and larger |
2and larger |
1.80 |
0.70 |
17.6 |
6.86 |
Removable Needle Attachment—
The requirements are met if the individual values of the 5sutures are within the limits shown in
Table 2.
Table 2.Removable Needle Attachment for Absorbable and Nonabsorbable Sutures
| Metric Size (Gauge No.) |
|
Limits on Needle Attachment |
| Absorbable Collagen Suture |
Nonabsorbable and Synthetic Absorbable Sutures |
USP Size |
Minimum (in kgf) |
Maximum (in kgf) |
Minimum (in N) |
Maximum (in N) |
| 1.5 |
1 |
5-0 |
0.028 |
1.59 |
0.274 |
15.6 |
| 2 |
1.5 |
4-0 |
0.028 |
1.59 |
0.274 |
15.6 |
| 3 |
2 |
3-0 |
0.028 |
1.59 |
0.274 |
15.6 |
| 3.5 |
3 |
2-0 |
0.028 |
1.59 |
0.274 |
15.6 |
| 4 |
3.5 |
0 |
0.028 |
1.59 |
0.274 |
15.6 |
| 5 |
4 |
1 |
0.028 |
1.59 |
0.274 |
15.6 |
| 6 |
5 |
2 |
0.028 |
1.59 |
0.274 |
15.6 |
[NOTE—For either type of attachment,if not more than 1of the individual values falls outside the prescribed limits,repeat the test on an additional 10sutures:the requirements of the test are met if none of the 10additional values falls outside the individual limit requirements.
]