Medical Device Validation Articles & Analysis: Older
2 articles found
The International Organization for Standardization has also established global package validation requirements for medical devices. ISO 11607-2: 2019 provides guidelines for developing and validating sterile medical packaging systems. ...
For critical cleaning applications it is best to use deionized or distilled water, as rinsing with ordinary water may introduce new contaminates. Validation procedures: Cleaning validation is a part of the regulatory compliance process for medical device manufacturing and reprocessing. Validation ensures that ...