Full Description

Scope: 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 sterilizationprocesses.

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 andsteaming of pipelines.

It does not specify requirements for the selection and use of biological indicators intended to monitorvaporised hydrogen peroxide processes for isolator and room biodecontamination processes atatmospheric pressure.

It is not applicable to liquid immersion sterilization processes.

Cross References:
ISO/IEC Guide 2
ISO 18472
ISO 11737 (all parts)
ISO 14937
ISO 20857
ISO 11135
ISO 9001
ISO 11138 (all parts)
ISO 13485
ANSI/AAMI ST79
EN 1422
EN 285
ISO/IEC 17025
ISO 17665-1
ISO 19011
ISO/IEC 17011
ISO 11139:2018


All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published: 05/01/2019 ISBN(s): 9780580992780 Number of Pages: 72 File Size: 1 file , 2.9 MB Same As: ISO 11138-7:2019 Product Code(s): 30363626, 30363626, 30363626 Note: This product is unavailable in United Kingdom