Asunto(s)
Contaminación de Equipos , Equipos y Suministros de Hospitales , Óxido de Etileno/administración & dosificación , Hidrocarburos Bromados/administración & dosificación , Polímeros/farmacología , Absorción , Relación Dosis-Respuesta a Droga , Óxido de Etileno/farmacocinética , Hidrocarburos Bromados/farmacocinética , Temperatura , U.R.S.S. , VolatilizaciónRESUMEN
Some of the drawbacks are discussed associated with hygienic norms for gaseous sterilizing agents in polymeric products for medical applications. A new approach is proposed for regulating ethylene oxide (EO) in such products. To this end, limiting types of biological effect and its pathways have been determined and substantiated as well as the reliability factor for establishing hygienic norms for EO in medical products. Daily threshold EO limit values were calculated for momentary and repeated exposure of humans. The duration of long-term and short-term exposure of the patient to sterilized products was evaluated on the basis of EO extraction kinetics from a variety of materials. Using daily threshold limit values, threshold residual values (TRV) of EO were calculated for different groups of polymeric products for medical applications.
Asunto(s)
Equipos y Suministros , Óxido de Etileno/normas , Esterilización/normas , Animales , Óxido de Etileno/toxicidad , Humanos , Concentración Máxima Admisible , Ratas , Esterilización/métodosRESUMEN
The balanced sorption of a sterilizing gas--ethylene oxide (EO)--by medical polymers most commonly used in medical industry is studied. These polymers are compositions on the base of polyvinylchloride (PVC), polyethylene (PE), natural and silicone rubbers. The absorption coefficients for EO and the above materials are calculated. The most sorption capacity is inherent in the PVC-based compositions and the least one--in the PE-based materials. The latters as well as silicone rubber materials are recommended for medical engineering products subjected to gaseous sterilization.