Nuevo proyecto
ISO/AWI 11137-2
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
Reference number
ISO/AWI 11137-2
ISO/AWI 11137-2
Edition 4
© ISO 2024
Nuevo proyecto
Resumen
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
Informaciones generales
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Estado: En desarrolloEtapa: Nuevo proyecto aprobado [10.99]
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Edición: 4
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Comité Técnico :ISO/TC 198
- RSS actualizaciones
Ciclo de vida
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Anteriormente
PublicadoISO 11137-2:2013
PublicadoISO 11137-2:2013/Amd 1:2022
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Ahora
