Sterilization of an Electronic Medical Device

• Author(s): Reis, Joana ; Cabo Verde, Sandra ; Capela Silva, Fernando ; Frias, Clara ; Potes, José ; Melo, Rita ; Nunes, Inês ; Marcos, Helena ; Silva, Telma ; Botelho, Maria Luísa
• Date: 2010
• Persistent ID: http://hdl.handle.net/10174/2761
• Origin: Repositório Científico da Universidade de Évora
• Subject(s): Ionizing radiation; Programmable memories; Ultra-violet radiation
• Document Type: Lecture
• Language: English

Description

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.