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Norma em Revisão : |
Norma em processo de adoção pela ABNT.
Clique Aqui
para participar da elaboração.
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Data de Publicação : |
27/07/2010 |
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Título : |
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
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Título Idioma Sec. : |
Évaluation biologique des dispositifs médicaux — Partie 10: Essais d'irritation et de sensibilisation cutanée
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Comitê : |
ISO/TC 194 Biological evaluation of medical devices
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Organismo :
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ISO - International Organization for Standardization
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Objetivo : |
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
ISO 10993-10:2010 includes:
pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
details of in vivo (irritation and sensitization) test procedures;
key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
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Normas Necessárias para a aplicação da
ISO 10993-10:2010
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ICS/CIN
Tabela internacional criada pela ISO para classificação e recuperação de normas técnicas
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| 11.100.20 - Avaliação biológica dos dispositivos médicos |
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Palavras-Chave
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