Medical grade

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.

ISO 10993-5 Test for Cytotoxicity ISO 10993-10 Tests for Irritation and Sensitisation ISO 10993-11 Tests for Systemic Toxicitiy
CB2003 CB1603 CB1603
CB2004 CB2000W CB2000W
CB2028 CB2008 CB2008
CB2075 CB2011 CB2011
CB2040-05 CB2028 CB2077
CB2241 CB2077 CB2800
CB2241-05 CB2800
CB2243
CB5005
CB5241

 

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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