Tema de trabajo aprobado
ISO/AWI 13408-4
Aseptic processing of health care products — Part 4: Cleaning processes for surfaces used within a critical processing zone
Reference number
ISO/AWI 13408-4
Edition 2
© ISO 2026
Tema de trabajo aprobado
En desarrollo
Un grupo de trabajo ha preparado un borrador.
Reemplazará ISO 13408-4:2005

Resumen

This document specifies the general requirements for, and offers guidance on, the qualification, validation, operation and control of cleaning processes for surfaces used within a critical processing zone in an aseptic processing area for the manufacture of a health care product. The requirements and guidance encompass clean-in-place, automated and manual cleaning processes. A risk-based approach is adopted to establish the suitability of a cleaning process within a contamination control strategy and as an essential prerequisite to disinfection or sterilization of surfaces. The principles and information in this document are applicable to the processing of products covered by ISO 18362. This document is not applicable to cleaning processes conducted in a washer-disinfector as described in the ISO 15883 series.

Informaciones generales

  • Estado
     : En desarrollo
    Etapa
    : Nuevo proyecto registrado en el programa de trabajo TC/SC [20.00]
  • Edición
     : 2
  • Comité Técnico :
    ISO/TC 198
  • RSS actualizaciones

Ciclo de vida

Objetivos de Desarrollo Sostenible

Esta norma contribuye al siguiente Objetivo de Desarrollo Sostenible

3
Good Health and Well-being

¿Tiene alguna duda?

Consulte nuestras Ayuda y asistencia

  2. Tienda
  3. Tienda
  4. ICS
  5. ISO/AWI 13408-4