Reference number
ISO/TS 11137-4:2020
ISO/TS 11137-4:2020
© ISO 2025
Technical Specification
ISO/TS 11137-4:2020
Sterilization of health care products — Radiation — Part 4: Guidance on process control
Edition 1
2020-06
2020-06
Technical Specification
ISO/TS 11137-4:2020
69443
Publicado
(Edición 1, 2020)
Esta publicación se revisó y confirmó por última vez en 2024.
Por lo tanto, esta versión es la actual.
Resumen
This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.
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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: 2020-06Etapa: Norma Internacional confirmada [90.93]
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Edición: 1Número de páginas: 55
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Comité Técnico :ISO/TC 198ICS :11.080.01
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