Standard

SN EN ISO 11138-7:2019

Nov 2019 Current

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Abstract

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.

Products specifications

Standard from INB
Published: November 1 2019
Effective: November 1 2019
Document type: EN
Pages
ISBN:

ICS: 11.080.01
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 171
European TC: CEN/TC 102
International TC: ISO/TC 198

Product Relations

Adopted from: ISO 11138-7:2019, IDT
Replaces: SN EN ISO 14161:2010

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Version history History (2)