This publication establishes the minimum requirements for the manufacture, analysis, and qualification of calibration gas standards used to qualify gases regulated by the U.S. Food and Drug Administration (FDA) or Health Canada (HC). The intent of this publication is to ensure consistent manufacture of calibration gas standards.
This publication applies to the manufacture, analysis, and qualification of primary gas standards used to calibrate analytical equipment used to verify the concentration of standards. It also applies to the manufacture and analysis of certified gas standards used to calibrate analytical instruments used to test FDA or HC regulated gases.
This publication does not apply to the manufacture of calibration gas standards classified as medical devices.