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I.S. EN ISO 11138-8:2021

Current

Current

The latest, up-to-date edition.

Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

15-08-2021

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Selection and preparation of samples
6 Exposure and culturing
7 Determination of reduced incubation time
Bibliography

This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.

Committee
ISO/TC 198
DocumentType
Test Method
Pages
24
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
ISO 11138-8:2021 Identical
EN ISO 11138-8:2021 Identical

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