Key aspects of performance test criteria for disposable polymer tissue ligating clips Ⅱ

Ⅲ. Biological performance test

Cytotoxicity: assess the toxic effect of the closure clip material on cells to ensure that it will not trigger cell death or damage when used in living organisms.

Sensitization reaction: test whether the closure clip material will cause allergic reaction to ensure its safety during use.

Intradermal Reaction: Evaluates the skin irritation of the closure clip material by methods such as intradermal injection.

Acute Systemic Toxicity: Tests whether the closure clip material will cause a systemic toxic reaction when exposed to a single large dose.

Subchronic Systemic Toxicity: To assess whether the closure clip material causes a systemic toxic reaction when exposed over a longer period of time.

Implantation reaction: Tests the reaction of the closure clip after implantation into an organism, including histocompatibility and inflammatory reaction.

Genotoxicity: Evaluates whether the closure clip material is genotoxic, i.e., whether it causes gene mutations or chromosomal abnormalities.

Pyrogenic: Test whether the closure clip material contains pyrogenic substances to ensure that it will not cause a febrile reaction during use.

IV. Other Performance Tests

Sterilization effect test: verify the sterilization process of the closure clip and its Sterility Assurance Level (SAL) to ensure that the product will not cause infection during use.

Packaging and packaging integrity testing: within the declared expiration date and under the conditions of transportation and storage, to verify the basis for maintaining the integrity of the packaging.

Animal experimental research: Select appropriate animal models to carry out animal experimental research on closure clips to assess their effectiveness and safety in actual use.

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