ASTM F3127 PDF
ASTM F3127 PDF
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ASTM F3127 PDF

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Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

Published byPublication DateNumber of Pages
ASTM04/01/201616

ASTM F3127 – Standard Guide for Validating Cleaning Processes Used During the Manufacture ofMedical Devices

1.1 This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. The considerations include but are not limited to, validation approach, equipment design, procedures and documentation, analytical methods, sampling, development of limits, and other issues.

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