The main aspects of the performance test standards of disposable polymer tissue ligature clips Ⅰ

I. Physical performance test

Appearance inspection: Check whether the appearance of each component of the closure clip is intact, and whether the surface structure is uniform, smooth and free from cracks, burrs and other defects.

Specification size and tolerance: Measure the three-dimensional size of the closing clamp to ensure that it meets the design requirements, and check whether the size deviation is within the permitted range.

Clamping Performance Test: Matching Performance with Clamping Vise: Evaluate whether the Clamping Vise and the Clamping Vise match smoothly, and whether it can clamp and close the tissue smoothly.

Clamping Stability: Tests the stability of the Closure Clamp once the tissue has been clamped to ensure that it does not slip out of place easily.

Clamping durability: In a period of time (e.g. 72 hours) after clamping the tissue, check whether the closure clamp maintains the clamping state, without loosening or breaking phenomenon.

Pressure resistance: Simulate the environment under a certain water pressure and test whether the simulated tissues (e.g. silicone tube) are free from leakage after the closure is clamped.

Repeated opening and closing test: Repeatedly open and close the closure clamp to check whether it is broken, deformed and other damage.

Ⅱ Chemical performance test

Material identification: Use infrared spectroscopy, nuclear magnetic resonance and other methods to identify the polymer material to ensure that it meets the design requirements.

Average molecular weight and molecular weight distribution: Measure the average molecular weight and molecular weight distribution of polymer materials to evaluate their physical properties and processing performance.

Extractable metal content: Detect the content of extractable metals in polymer materials to ensure that it is within the safe range.

pH, evaporation residue, UV absorbance: Test the pH, evaporation residue and UV absorbance of polymer materials to assess their chemical stability and safety.

The performance test standards of disposable polymer tissue closure clips cover many aspects such as physical properties, chemical properties, biological properties and other performance tests. Donghao has accumulated rich experience in the development of such products, and together with the test standards, it ensures the safety and effectiveness of the closure clips, providing a strong guarantee for clinical use.

Ethylene oxide residue: If ethylene oxide is used for sterilisation, the residue of ethylene oxide in closure clips should be tested to ensure that it meets the relevant standards.