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Normas BSI – AENOR
BS EN ISO 25424:2011

BS EN ISO 25424:2011

Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices

Fecha Anulación:
2019-11-21 /Withdrawn
Comité:
CH/198
Equivalencias internacionales:

EN ISO 25424:2011

ISO 25424:2009

ISO 25424:2011

Relación con otras normas BSI:

Reemplazada por: BS EN ISO 25424:2019

Reemplaza a: BS EN 15424:2007

Resumen:
ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices. ISO 25424:2009 is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.
Keywords:
Specification (approval), Low temperatures, Quality control, Microbiological analysis, Sterilizers, Environmental engineering, Medical equipment, Verification, Sterilization (hygiene), Packaging, Qualification approval, Steam sterilizers, Formaldehyde, Performance testing
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