Reference number
ISO 11137-3:2017
ISO 11137-3:2017
© ISO 2025
International Standard
ISO 11137-3:2017
Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
Edition 2
2017-06
2017-06
ISO 11137-3:2017
63841
Publicado
(Edición 2, 2017)
Esta publicación se revisó y confirmó por última vez en 2022.
Por lo tanto, esta versión es la actual.
Resumen
ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
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ISO 11137 Radiation sterilization package
This package provides the foundational requirements (Part 1), specific methods for establishing the sterilization dose (Part 2), essential guidance on accurate dose measurement (Part 3), and practical advice on process control (TS Part 4), offering a holistic approach from development to routine monitoring.
- ISO 11137-1:2025
- ISO 11137-2:2013
- ISO 11137-3:2017
- ISO/TS 11137-4:2020
Informaciones generales
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Estado: PublicadoFecha de publicación: 2017-06Etapa: Norma Internacional confirmada [90.93]
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Edición: 2Número de páginas: 41
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Comité Técnico :ISO/TC 198ICS :11.080.01
- RSS actualizaciones
Ciclo de vida
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Anteriormente
RetiradaISO 11137-3:2006
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Ahora
