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Sterilization of an Electronical Medical Device

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Resumo:Radiosterilization was applied to a medical device with a “programmable memory” to allow in vivo implantation. Irradiation on a Cobalt-60 facility at 25 kGy at a dose rate of 2kGy/h corrupted the memory. Therefore an alternative sterilization method using UV was developed and validated based on ISO 11737-1 and ISO 14937. These procedures may be useful and effective for research purposes when only a small number of items might be involved but applicability at an industrial scale is unlikely.
Autores principais:Reis, Joana
Outros Autores:Cabo Verde, Sandra; Capela Silva, Fernando; Potes, José; Melo, Rita; Nunes, Inês; Marcos, Helena; Silva, Telma; Botelho, Maria Luísa
Assunto:ionizing radiation ultraviolet radiation programmable memories
Ano:2011
País:Portugal
Tipo de documento:artigo
Tipo de acesso:acesso aberto
Instituição associada:Universidade de Évora
Idioma:inglês
Origem:Repositório Científico da Universidade de Évora
Descrição
Resumo:Radiosterilization was applied to a medical device with a “programmable memory” to allow in vivo implantation. Irradiation on a Cobalt-60 facility at 25 kGy at a dose rate of 2kGy/h corrupted the memory. Therefore an alternative sterilization method using UV was developed and validated based on ISO 11737-1 and ISO 14937. These procedures may be useful and effective for research purposes when only a small number of items might be involved but applicability at an industrial scale is unlikely.