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BSI PD ISO/TS 21387:2020

Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
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BSI PD ISO/TS 21387:2020

Sterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release

PUBLISH DATE 2020
PAGES 26
BSI PD ISO/TS 21387:2020

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.

SDO BSI: British Standards Institution
Document Number ISO/TS 21387
Publication Date Sept. 16, 2020
Language en - English
Page Count 26
Revision Level
Supercedes
Committee CH/198
Publish Date Document Id Type View
Sept. 16, 2020 PD ISO/TS 21387:2020 Revision