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Norm

ISO 11138-7:2019

Issue date: 2019 03 12

Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results

This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation an...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 64 Pages
Language:
English

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.

ISO 11138-7:2019
2019 03 12
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, ...
Norm
ISO 14161:2009
2009 09 04
Sterilization of health care products — Biological indicators — Guidance for the selection, use and ...
Norm
ISO 14161:2000
2000 09 28
Sterilization of health care products — Biological indicators — Guidance for the selection, use and ...
Norm