This publication establishes the minimum requirements for the manufacture, analysis, and qualification of calibration gas standards used to qualify medical gases. The intent of this document is to ensure consistent manufacture of calibration gas standards.

This publication applies to the manufacture and analysis 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 medical gases. This document does not apply to the manufacture of calibration gas standards classified as medical devices.