scope:

This publication applies to medical gas manufacturers, medical gas equipment manufactures, and distributors developing company-specific standard operating procedures (SOP) for qualifying suppliers who provide medical gases and/or, medical devices, equipment, components, or services, including the services of contract drivers delivering medical gases.

It may be used when qualifying new suppliers or when requalifying existing suppliers of medical gases including other gases, which includes:

• original manufacturers of medical oxygen, nitrogen, carbon dioxide, helium, nitrous oxide, and air by compression, that swap with or directly supply to other original manufacturers or their customers;

• subsequent manufacturers of medical gases obtaining medical gases from an original manufacturer;

• subsequent manufacturers of medical gases obtaining medical gases from another subsequent manufacturer; and

• original manufacturers of medical gases obtaining feed gas sources for their purification processes.