GSO ASTM F3127:2021
Gulf Standard
Current Edition
·
Approved on
01 July 2021
·
Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
GSO ASTM F3127:2021 Files
English
16 Pages
Current Edition
Reference Language
GSO ASTM F3127:2021 Scope
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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