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.

Product Details

Published:

04/01/2016

Number of Pages:

16

File Size:

1 file , 300 KB