|ISO 10993-5 Test for Cytotoxicity||Technical data sheet||ISO 10993-10 Tests for Irritation and Sensitisation||Technical data sheet||ISO 10993-11 Tests for Systemic Toxicitiy||Technical data sheet|
Cyberbond manufactures ISO 10993-certified cyanoacrylate adhesives which are suitable for medical use. Cyanoacrylates are used in the manufacture of many medical devices. There are several approval norms like FDA (US Food and Drug Administration), USP (United States Pharmacopeia) or the ISO 10993 standard.
02 Product list
Cyberbond holds approvals for both USP class VI and ISO 10993 classifications. The norm ISO 10993, however, consists of various tests. The most important aspect is the biological compatibility which is the compatibility of an article on/ or inside a body. Cyberbond hold approvals include the following certifications:
ISO 10993-5 : Test for in vitro cytotoxicity: An Agar diffusion test checks if cyanoacrylates destroy a cell culture.
ISO 10993-10 : Tests for irritation and delayed-type hypersensitivity: Rabbits are injected intradermal. This means that the extracted cyanoacrylate is injected via a substrate in the deep layers of the dermis. The goal is to find out if, due to vascular dilation, there is an inflammable flush of the skin (erythma) or an accumulation of liquids (edema).
ISO 10993-11 : Tests for systemic toxicity: Mice are injected with the extracted cyanoacrylates via a substrate intravenously and intraperitoneal (in the abdominal cavity). There mustn’t be a biological reaction by the body.
USP Class VI: USP 25, NF 20 : Biological Reactivity Tests in vivo: This test is similar to 10993-10. In this test, mice and rabbits are injected intradermal. Besides, the medium was implanted in the paravertebral muscles of rabbits. No noticeable reactions should occur.
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