Biological Evaluation of Medical Devices: Evaluation Biologique Des Dispositifs Médicaux. Partie 10, Essais D'irritation Et de Sensibilisation. Tests for irritation and sensitization
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acclimatized and cared albino and/or Animals and husbandry appropriate catheter cheek pouch chemical control animals control group dose employed in preparing erythema and oedema eschar formation ethylene oxide eye irritant Freund's complete adjuvant guinea-pigs h and 72 Healthy young adult histological evaluation husbandry Healthy young Industry Ecology intended use/application intradermal irritation test lesions lf the response lf the test liquid lrritation Score lymph node main test material or device material or extract material under test microscopic evaluation moistened number of animals number of observations Observation of animals occlusive dressing OECD outbred strain penis perineum potential prepared as specified preparing the test Presentation of results Primary Irritation Principle Assessment prior prolonged repeated exposure rabbits readings were performed reagent control results The test sample sensitization tests specified in annex table D.2 test animals test material test material(s Test procedure test report test substance test to produce three animals vitro