Call for Consensus Body Voting Members: ANS CGA M-1, Standard for Medical Gas Supply Systems at Health Care Facilities
April 15, 2021
The Compressed Gas Association (CGA) is working to complete the revision of American National Standard (ANS) CGA M-1, Standard for Medical Gas Supply Systems at Health Care Facilities. This standard provides the minimum requirements for the design, installation, maintenance, testing, and removal of compressed medical gas (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 current good manufacturing practices (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, U.S. FDA;
- 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
To learn more about this safety standard, see our article, CGA’s M-1 Publication Guides Safe Use of Medical Gas Supply Systems at Health Care Facilities.
How to Apply for the Consensus Body
Currently, this ANS consensus body needs voting members from the following interest categories in order to be able to proceed with this publication:
- Producers: Manufacturers or distributors of compressed medical gases (oxygen USP and medical air USP) or manufacturers of medical gas supply or distribution systems;
- Users: Industrial customers and others who use compressed medical gases (oxygen USP and medical air USP) in medical gas supply systems;
- General interest: Academia, fire prevention officials, and those with a general interest in compressed medical gases (oxygen USP and medical air USP); and
- Code Developers: Trade associations, building and fire code developers, and other standards development organizations (for example, NFPA and ICC)
Please note that membership in CGA is not a requirement to join this ANS consensus body. Currently, there is no fee to join this ANS consensus body.
To ensure that the ANS consensus body interest categories remain in balance, voting privileges are assigned on a first-come, first-served basis to each eligible member who submits an ANS consensus body member application until a balanced consensus body is established. No new voting members will be added after the proposed change cutoff date has passed unless the ANS consensus body becomes unbalanced. If there are more applications for voting privileges than available positions, CGA will maintain a waiting list of potential voting members to be added if the ANS consensus body becomes unbalanced.
If you are interested in participating on this ANS consensus body as a voting member, send an email to CGA Committee Project Manager Kristy Mastromichalis no later than April 30, 2021, by completing the form below and clicking “Submit.” All required fields are marked with an asterisk (*).