Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices Ingestion-build-83346 For service industries

For service industries

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provided that they have been calibrated against the reference methods

and environmental tests

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Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices Ingestion-build-83346 For service industries1. 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,