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immediate downloadReleased: 2019-05-01
BS EN ISO 11138-7:2019
Sterilization of health care products. Biological indicators Guidance for the selection, use and interpretation of results
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| Standard number: | BS EN ISO 11138-7:2019 |
| Pages: | 74 |
| Released: | 2019-05-01 |
| ISBN: | 978 0 580 99278 0 |
| Status: | Standard |
DESCRIPTION
BS EN ISO 11138-7:2019
This standard BS EN ISO 11138-7:2019 Sterilization of health care products. Biological indicators is classified in these ICS categories:
- 11.080.01 Sterilization and disinfection in general
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.