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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
    Edition: 2020
    $435.35
    / user per year

Description of PD ISO/TS 21387:2020 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.



Standard NumberPD ISO/TS 21387:2020
TitleSterilization of medical devices. Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
StatusConfirmed
Publication Date2020-09-16
Identical National Standard OfISO/TS 21387
DescriptorsSterilization (hygiene), Diagnostic equipment (medical), Diagnostic instruments (medical), Medical diagnosis, Medical electronics, Ethylene oxide
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 539 02800 3
PublisherBSI
Pages26

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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