I.S. EN ISO 11138-8:2021
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)
Hardcopy , PDF
English
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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