The ISO 14644 standards are pretty blatant that since they are written to apply to numerous different industries, the standards have to avoid too many specifics. ISO 14644-5:2004 states in its scope, "This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries."
Are there specific requirements/best practices for cleanrooms that manufacture medical devices? Where do we find them?
Are there specific requirements/best practices for cleanrooms that manufacture medical devices? Where do we find them?
