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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 11138:2019

ISO 11138:2019 Sterilization of health care products – Biological indicators – Part 7: Guidance for the selection, use and interpretation of results

CDN $391.00

SKU: b17297325bd2 Categories: ,

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.

Edition

1

Published Date

2019-03-12

Status

PUBLISHED

Pages

64

Language Detail Icon

English

Format Secure Icon

Secure PDF

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.

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