This standard provides the minimum requirements for the design, installation, maintenance, testing, and removal of CMG supply systems at health care facilities. For facilities that are solely intended for use in non-human applications (i.e., veterinary or pharmaceutical), the applicability of this standard is to be determined by the CMG system designer, authority having jurisdiction (AHJ), or other related parties based on facility requirements. Strict adherence to CGMP shall be taken into account to prevent adulteration of the CMG.
This standard applies to all new or upgraded CMG supply systems at health care facilities. It provides direction for compliance with the following national regulations and model codes:
• Federal Food, Drug, and Cosmetic Act;
• Title 21 of the U.S. Code of Federal Regulations (21 CFR) Parts 210 to 211;
• NFPA 55, Compressed Gases and Cryogenic Fluids Code; and
• NFPA 99, Health Care Facilities Code.
Section 5 covers the scope of these regulations and their applicability to CMG supply systems. This standard captures the requirements from these codes along with best practices to provide a comprehensive publication for the process of designing, locating, installing, commissioning, maintaining, testing, removing, and documenting work on a medical gas supply system.
In an upgrade, the complete system shall be modified to comply with current standards. Failure of individual components may not invoke a full system upgrade. An exception is replacing piping or control assemblies that do not include the replacement or relocation of the bulk liquid storage vessel(s) may not invoke the foundation requirements in 8.2.
This standard does not apply to:
• piped distribution systems including source valve requirements;
• manufacture of assemblies such as pressure control manifolds that are manufactured in a supplier's shop and qualified for medical gas service in accordance with the CMG supply system installer’s policies;
• manufacturing plants or other establishments operated by the supplier or the supplier’s agent for the purpose of storing and refilling portable containers, trailers, mobile supply trucks, or tank cars with medical gases;
• nonhealth care facilities such as laboratories, pharmaceutical, or biotechnology facilities;
• medical vacuum systems; or
• supply systems that generate CMG on-site.