non-absorbable surgical sutures

1. Product Models and Specifications Provocative Division Instructions

2. Standard
1. Appearance: smooth without burrs, without oil on the surface
2. Tensile strength (minimum): 0.1mm: 1.0N; 0.3mm: 6.5N; 0.5mm; 20N; with
needle strength can be slightly lower
3. Length: ≥ Indicates length95%
4.Chemical residue
1) Water content: PLA, PLGA: ≤ 0.05%
2) Heavy metals: the color of the extract is not dark, such as 1 ug / ml Pb
Standard solution color
Take 0.25 g suture, add 20 ml distilled water, 37℃ soak for 24 hours and take
the extract for test.
3) Soluble CR of chrome suture: the color of the extract shall not exceed 1 ppm
Standard solution color Take 0.25 g suture, add 20 ml distilled water, 37℃
soak for 24 hours and take the extract for test.
4) Ethylene oxide residue: ≤ 250 ug / g Exposure limit of ethylene oxide:
1) short term exposure (t ≤ 24 h): the average daily dose shall not exceed 4
mg / d;
2)Long term exposure (24 h ≤ t ≤ 30 d): the average daily dose does not
exceed 2 mg / D, and the maximum dose is No more than 4 mg in the first 24
hours and no more than 60 mg in the first 30 days; 3) Permanent contact (≥ 30
d):
The average daily dose shall not exceed 0.1 mg / D. in addition, the maximum
dose shall not exceed 4 mg in the first 24 hours and 30 days Not more than 60
mg, not more than 2.5 g/L.
5. Characterization of biological propertie
Preparation of extract sample: take a certain amount of suture sample, such as
PBS solution, in 37 Soak for 24 h under C and remove
For the test of extraction solution,according to the ratio of suture surface area
to extraction medium volume.
6.Sterile, Gamma Sterilization