ANSI/AAMI/ISO 11138-8:2023
Current
The latest, up-to-date edition.
Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator
English
30-06-2023
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.
| DocumentType |
Test Method
|
| ISBN |
978-1-57020-874-4
|
| Pages |
17
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| ISO 11138-8:2021 | Identical |
| ISO 11138-7:2019 | Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
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