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ISO 11138-7:2019

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

standard by International Organization for Standardization , 03/01/2019

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Full Description

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.

 

Product Details

Edition:
1st
Published:
03/01/2019
Number of Pages:
72
File Size:
1 file , 7.8 MB
Same As:
BS EN ISO 11138-7:2019, DIN EN ISO 11138-7
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 11138-7:2019

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

    • Most Recent

  2. ISO 14161:2009


    Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

    • Historical Version

  3. ISO 14161:2000


    Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results

    • Historical Version