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Biological Evaluation

 

 

BIOLOGICAL EVALUATION
(JO/02/11) OF MEDICAL DEVICES - TEST METHODS

Intracutaneous Test - Rabbits And systemic injection studies

System Injection SYSTEMU INJECTION

 

GENERAL PROCEDURE: The intracutaneous Test is designed to evaluate local responses to the extracts of test articles following intracutaneous injection into rabbits. The test article was extracted in NaCl and CSO at a ratio of 6cm2 per 1 ml at 70+ 2'C for 24 hours. Control extracts were prepared, in a similar manner to the test article. with each extracting medium. Three rabbits were injected intracutaneously, using one side of the animal for the test article extracts and the other side for the control extracts. At 0.2 ml per site. The injected sites were examined at 24, 48 and 72 hours post inoculation for gross evidence of issue reaction such as ertheme, edema and necrosis. Values were calculated by averaging the scores for each of the last article and control extracts for each of three individual animals. This was performed by adding the scores for each animal for erythema and edema after each exposure. This total was divided by 15. The control score was subtracted from the test article score. Then. this calculated value for each animal was added together for a total of three animals. The total was divided by 3 to obtain the Primary irritation index. A Primary irritation index of 0.5 or less will be considered a negligible irritant. Test articles with indices greater than 0.54 to less than 2.0 will be slight irritants. Test articles with indices of 2.0 to less than 5.0 will be moderate irritants. Any lest article with an index of 5.0 or more will be considered severe irritants.
 
RESULTS: The last sites injected with the test article extracts did not exhibit any signs of erythema and edema through the seventy-two hour observation point. The Primary irritation index for both NaCl and CSO extracts of this test article is 0.0.
 

INTRACUTANEOUS TESTS (RABBITS)

 

GENERAL PROCEDURE: The Systearnic injection Study is designed to screen solutions and lest articles extracts for potential toxic effects as a result of a single-does systemic injection in mice. The test article was extracted in NaCl and CSO at a ratio of 6.0gm per 1.0mL at 70720C for 24 hours. The test article extracts were injected intravenously (NaCl) and intraperitioneally (CSO) at 50mL/Kg, in groups of five mice. Similarly, groups of five mice were injected with the control articles (vehicles). The animals were observed for signs of biological reactivity for 72 hours post inoculation.

 

RESULTS: None of the animals injected with the test article extracts or the control articles (vehicles) exhibited any signs of toxicity through the observation period.

 

CONCLUSION: The animals treated with the test article extracts did not exhibit biological reaction greater than the controls. Therefore, the test article meets the requirements of EN/ISO 10993-11 for the Systemic Injection Test.