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Freigaben medizinische Industrie

ISO 10993 Approvals

Cyanoacrylates and UV curable adhesives are used to a great deal in medical instruments. Applications are for instance gluing of needles in plastics like syringes. These products are tested before used for medical purposes. However, it is thoroughly favourable if one can assure that the used adhesive is not dangerous for human beings and animals. There is a large number of approval norms like FDA (US Food and Drug Administration), USP (United States Pharmacopeia) or ISO 10993 standard. 

For Cyanoacrylates und UV curable adhesives the approval norm USP class VI and ISO 10993 are mainly applicable. Cyberbond holds approvals for both classifications; lately we have concentrated on ISO 10993 as it is highly recommended at an international level and meets strict regulations.

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 holds approvals for the following:

ISO 10993-5: Test for in vitro cytotoxicity

In an Agar diffusion test it is checked if the used adhesive destroys a cell culture. 

ISO 10993-10: Tests for irritation and delayed-type hypersensitivity

Rabbits are injected intradermal. This means that the extracted adhesive is injected via a substrate in the deep layers of the dermis to find out if  – due to vascular dilation – there is an inflammable flush of the skin (erythma) or an accumulation of liquids (edema)
(CB 1603, 2000W respectively 2800, 2008, 2011, 2028, 2077) 

ISO 10993-11: Tests for systematic toxicity

Mice are injected with the extracted adhesive via a substrate intravenously and intraperitoneal (in the abdominal cavity). There mustn’t be a biological reaction by the body (CB 1603, 2000W respectively 2800, 2008, 2011, 2028, 2077) 

USP Class VI: USP 25, NF 20: Biological Reactivity Tests in vivo

This test is similar to 10993-10. For this mice and rabbits are injected intradermal. Besides, the medium was implanted in the paravertebral muscles of rabbits. No noticeable reactions should occur. (CB 1603, 2000W respectively 2800, 2008, 2011, 2028, 2077)