AAMI/ISO TIR21387:2023
Current
Current
The latest, up-to-date edition.
Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
30-06-2023
€157.50
Excluding VAT
This document provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-872-0
|
| Pages |
29
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| ISO/TS 21387:2020 | Identical |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
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