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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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.