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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 : |
27/11/2002 |
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Título : |
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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Título Idioma Sec. : |
Évaluation biologique des dispositifs médicaux — Partie 17: Établissement des limites admissibles des substances relargables
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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 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
ISO 10993-17:2002 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. ISO 10993-17:2002 does not address the potential for exposure from such sources.
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Normas Necessárias para a aplicação da
ISO 10993-17:2002
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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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