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BS 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

standard by BSI Group , 09/16/2020

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Full 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.

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Product Details

Published:
09/16/2020
ISBN(s):
9780539028003
Number of Pages:
26
File Size:
1 file , 1.2 MB
Product Code(s):
30385899, 30385899, 30385899
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