International Standard
ISO 11138-7:2019
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
Reference number
ISO 11138-7:2019
Edición 1
2019-03
International Standard
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ISO 11138-7:2019
74113
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Publicado (Edición 1, 2019)

ISO 11138-7:2019

ISO 11138-7:2019
74113
Formato
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CHF 194
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Resumen

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.

It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.

It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.

It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.

It is not applicable to liquid immersion sterilization processes.

Informaciones generales

  •  : Publicado
     : 2019-03
    : Norma Internacional en proceso de revisión sistemática [90.20]
  •  : 1
     : 64
  • ISO/TC 198
    11.080.01 
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