ISO 21387:2020
ISO 21387:2020 Sterilization of medical devices – Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
CDN $173.00
Description
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. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Additionally, it highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process.
NOTE For ease of reference, the numbering of clauses in this document corresponds to that in the normative parts of ISO 11135.
No additional guidance is offered for processes where the declaration of adequacy of the validated sterilization cycle includes a requirement for no growth in biological indicators (BIs) exposed to that process.
Edition
1
Published Date
2020-09-15
Status
PUBLISHED
Pages
17
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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. It provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Additionally, it highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process.
NOTE For ease of reference, the numbering of clauses in this document corresponds to that in the normative parts of ISO 11135.
No additional guidance is offered for processes where the declaration of adequacy of the validated sterilization cycle includes a requirement for no growth in biological indicators (BIs) exposed to that process.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 11138:2019 Sterilization of health care products – Biological indicators – Part 7: Guidance for the selection, use and interpretation of results
CDN $351.00 Add to cart -
ISO 17664:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices
CDN $233.00 Add to cart -
ISO 13408:2023 Aseptic processing of health care products – Part 1: General requirements
CDN $351.00 Add to cart -
ISO 11737:2021 Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products – Amendment 1
CDN $32.00 Add to cart
