BS PD ISO/TS 21387:2020

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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