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Lunes 23 de Set, 2024
Full title: Medical Device Chemical Toxicological Risk Assessments: Applying Toxicological Principles to Meet the Challenge Medical device chemical toxicological risk assessment is challenging because the risk assessor often needs to consider the many types of device intended uses, many types of materials used in design and manufacturing, and many types of intentional and unintentional chemicals that are or could be present in the final finished device. Medical device intended uses include the type of tissue contact, the contact frequency and duration, and the susceptibility of the device user to chemical exposure. Material factors include the material type (e.g., alloy, polymeric, ceramic, or natural), material properties (e.g., alloy surface characteristics, polymer plasticity, or polymer manufacturing process), and material chemical composition (e.g., chemical formulation, potent toxicants (if present), and the rate and duration of release). How to apply these considerations is described in the U.S. Food and Drug Administration (FDA) 2020 guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices: Part 1: Evaluation and testing within a risk management process,” International Standard Organization (ISO) 10993 series, and ISO 14971. This presentation will describe how chemical toxicological risk assessment fits into the overall medical device biological risk management process (i.e., risk analysis, risk evaluation, or risk control). Additionally, what medical device chemical toxicological information to consider from the U.S. FDA 2020 guidance and ISO documents when estimating chemical toxicological risk will be covered, such as: approaches for estimating an exposure dose, deriving a tolerable intake (TI), and other critical factors to consider that could be useful in the determination of whether exposure to a medical device chemical presents a tolerable risk or could present a possible toxicological risk.
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La Autoridad Portuaria de la Bahía de Algeciras (APBA) ha instalado cámaras térmicas en las zonas de mayor tránsito de pasajeros del puerto para controlar la temperatura corporal de los pasajeros sin necesidad de pararles. ... Leer más ►
Tags: Casos, Transporte, Video analítica
Publicado el 2-Jul-2020 • 14.23hs
Publicado el 25-Ene-2017 • 19.27hs
Publicado el 20-Ene-2017 • 13.11hs
Publicamos grabación de webinar que tuvo lugar el pasado 28/03/2019 por el CIO del Grupo de Medios de Comunicación español Vocento Jorge Oteo en el que explica su visión de la Ciberseguridad hoy. ... Leer más ►
Tags: Teoría, Medios de Comunicación, Ciberseguridad, Webinars grabados
Publicado el 29-Mar-2019 • 10.12hs
Publicado el 20-Jun-2018 • 11.21hs
Publicado el 31-May-2018 • 10.21hs
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Tags: Producto, Todos, Ciberterrorismo
Publicado el 23-Jun-2020 • 16.05hs
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Publicado el 20-Jun-2014 • 17.17hs
Publicado el 31-May-2011 • 05.13hs
Publicado el 25-Set-2008 • 17.54hs
Publicado el 1-Set-2016 • 16.11hs
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Publicado el 26-Set-2019 • 10.36hs
Publicado el 29-Mar-2019 • 10.12hs
Publicado el 23-Jun-2020 • 16.05hs
Publicado el 15-Mar-2019 • 10.41hs
Publicado el 4-Feb-2016 • 11.56hs
Publicado el 21-Jun-2012 • 22.28hs
Publicado el 13-Jul-2012 • 07.12hs
Publicado el 17-Ene-2012 • 10.22hs
Publicado el 25-Ene-2017 • 19.27hs
Publicado el 18-Set-2013 • 17.44hs
Publicado el 17-May-2018 • 10.47hs
Publicado el 28-Dic-2015 • 12.39hs
Publicado el 5-Feb-2016 • 13.01hs
Publicado el 2-Jul-2020 • 14.23hs
Publicado el 25-May-2016 • 13.01hs