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    Evaluación biológica de dispositivos médicos - Aplicación del umbral de preocupación toxicológica (TTC) para evaluar la biocompatibilidad de los componentes de dispositivos médicos.

    Objeto y campo de aplicación

    This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a medical device. The TTC values in this document can be used for: — comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 10993-18); — supporting toxicological equivalence; — comparing to a maximum exposure dose estimate of an identified constituent (see ISO 10993-17). NOTE Constituent is defined in 3.1. ISO 10993-18 specifies how to convert TTC (µg/d) into a concentration (µg/ml). TTC is not applicable to constituents with adequate toxicity data for deriving a tolerable intake (TI) value (see ISO 10993-17). The TTC values established in this document are protective for carcinogens, systemic toxicants, and reproductive toxicants (see Clause 5). This document does not include TTC values for other biological endpoints assessed as part of the biological evaluation of a medical device, per ISO 10993-1, for example: — cytotoxicity; — irritation; — sensitization; — hemocompatibility; — material mediated pyrogenicity; — local effects that occur in tissues at the site of contact between a medical device and the body (e.g. the observations from implantation studies). The TTC values in this document do not apply to potential exposure via gas pathways of medical devices. For application of TTC for constituents present/released from these devices, see the ISO 18562 series. The TTC values presented in this document are not applicable for the safety assessment of cohort of concern (see 5.3).

    Información general

    Código del comité
    EN 
    Nombre del comité
    Endoso 
    Sector
    Salud 
    ICS
    11.100.20  
    Correspondencias
    ISO/TS 21726:2019  
    Organismos
    ISO  
    Edición
    Fecha de aprobación
    2020-06-30 
    Número de páginas
    11 
    Estado
    Vigente 

    Normas de Referencia
    ISO 10993-1:2018, ISO 10993-17, ISO 10993-18

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