Tag Archives: CGA

CGA PS-35

CGA Position Statement on Filling and Distributing Emergency Oxygen Cylinders Without a Prescription

Published by: 2017-02-01 / 2017-02-01 / 3 pages
The U.S. Food and Drug Administration (FDA) considers oxygen, USP a prescription drug. In the interest of public safety, FDA permits properly trained first responders and properly trained professionals (emergency medical service providers, facility/institution medical representatives, company CPR providers, etc.) to dispense oxygen, USP without a prescription for use in emergency situations (emergency oxygen). This publication describes the responsibilities of the emergency oxygen filler, distributor, and user.

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CGA M-20

Guideline for the Implementation of Unique Device Identification

Published by: 2017-02-01 / 2017-02-01 / 12 pages
This publication describes the industry position of both manufacturers and distributors of medical devices used in the medical gas and gas equipment industry regarding 21 CFR Part 830 and associated guidance. It describes the industry’s interpretation and application of the requirements for the creation and maintenance of device barcodes and the submission of the related database records in electronic format. This pub-lication should be utilized to create a firm’s standard operating procedures (SOP) for compliance with the regulation.



This publication is based upon:

  • 21 CFR Part 830 [1];
  • FDA’s GUDID guidance [2]; and
  • the Compressed Gas Association’s (CGA) letters to FDA regarding these issues dated November 1, 2012 and July 8, 2014.

This publication does not include guidance for implementation of UDI for standalone software. See 21 CFR Part 801 for guidance for standalone software.

This publication does not cover product codes BXK or NXF (i.e., gases used for calibration and other purposes). Gases included in these product codes are the subject of CGA’s letters to FDA dated November 1, 2012 and July 8, 2014.

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CGA C-26

Guideline for the Post Manufacture Tare Weight Marking of Cylinders

Published by: 2017-02-01 / 2017-02-01 / 10 pages
This publication defines terminology, requirements, and procedures for the post manufacture marking of tare weights on cylinders of 1000 lb (454 kg) or less water capacity to be filled with liquefied compressed gas and other gases where the cylinder could require a tare weight. This publication does not apply to cylinders used in acetylene service.

The information contained in this publication enhances the safety of packaging offered for transportation. These recommendations in no way supersede any existing state or local regulations or regulations of any other jurisdictions.

This publication does not address the requirements of filling cylinders with a liquefied gas. For liquefied gas filling, see Parts 173.304, 173.304a, and 173.304b 49 CFR or CSA B340 for specific requirements.

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CGA PS-45

CGA Position Statement on on Transport of Compressed Gas Cylinders and Cryogenic Liquid Containers in Elevatorss

Published by: 2016-11-01 / 2016-11-01 / 3 pages
This position statement outlines precautions that need to be considered for the safe transport of gas cylinders and cryogenic liquid containers in elevators based upon the type and quantity of the gas and the design of the cylinder/container. It provides information for handling cylinders and cryogenic liquid containers and is appropriate for transporting inert and oxidizing atmospheric gases and mixtures in elevators. Additional precautions may be warranted for toxic or flammable gases depending upon the gas, quantity, and type of cylinder/container. It is not applicable to the transport of cylinders or containers in an elevator while in use for patient care.

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CGA PS-48

CGA Position Statement on Clarification of Existing Hydrogen Setback Distances and Development of New Hydrogen Setback Distances in NFPA 55

Published by: 2016-03-01 / 2016-03-01 / 4 pages
This position statement provides recommendations for dealing with undefined exposures and which defined exposures are closest in nature in NFPA 55.

For unclear requirements in NFPA 55, installers of hydrogen storage systems should use the recommendations in this position statement.

CGA will be requesting that NFPA 55 refer to PS-48 for clarification of unclear separation distances.

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CGA G-8.4

Safe Practices for the Production of Nitrous Oxide From Ammonium Nitrate

Published by: 2016-04-01 / 2016-04-01 / 24 pages
This publication serves the interest of all who could, in any way, be associated or concerned with nitrous oxide manufacturing from the thermal decomposition of ammonium nitrate. It also serves to acquaint persons not versed in ammonium nitrate and nitrous oxide technology with those factors considered important to health and safety.

This publication applies to safety in the design, construction, installation, operation, and maintenance of nitrous oxide plants using ammonium nitrate technology. Emphasis is placed on equipment, operational, and maintenance features that are particular to nitrous oxide plants.

This publication is not applicable to the process of production of nitrous oxide from other raw materials, but may be used as a guideline for the purification, drying, compression, liquefaction, and storage as applicable.

Nitrous oxide emissions during production are not covered by the scope of this publication.

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CGA C-1

Methods for Pressure Testing of Compressed Gas Cylinders, Eleventh Edition

Published by: 2016-02-01 / 2016-02-01 / 48 pages
Pressure testing of compressed gas cylinders is required for many newly manufactured cylinders and also is an accepted test method for the requalification of cylinders. This standard contains operating and equipment requirements necessary to properly perform pressure testing of compressed gas cylinders. Tests include the water jacket method, direct expansion method, and proof pressure method.

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CGA P-15

Filling of Industrial and Medical Non-Flammable Compressed Gas Cylinders

Published by: 2016-04-01 / 2016-04-01 / 40 pages
This publication describes the recommended industry practices and precautionary measures for filling certain liquefied and nonliquefied, nonflammable industrial, medical and food gas cylinders not exceeding 125-lb (57-kg) water capacity. It should not be assumed that every safety precaution is included here. This publication does not cover equipment design specifications to perform these filling operations.

This publication only covers the filling of U.S. Department of Transportation (DOT) 3A, Transport Canada (TC) 3AM, DOT 3AA, TC 3AAM, DOT 3AL, TC 3ALM, authorized United Nations (UN) equivalents for these cylinders, and aluminum composite cylinders with the following gases: air, argon, carbon dioxide, helium, nitrogen, nitrous oxide, and oxygen.

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CGA PS-44

CGA Position Statement on Designated Medical Gases are Not Active Pharmaceutical Ingredients

Published by: 2016-03-01 / 2016-03-01 / 2 pages
This position statement answers the question: Are designated medical gases ever considered active pharmaceutical ingredients (API) by the U.S. Food and Drug Administration (FDA).

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CGA M-16

Guidance for Electronic Records and Signatures in the U.S. and Canadian Food, Drug, and Medical Device Gas and Gas Equipment Industry

Published by: 2016-03-01 / 2016-03-01 / 16 pages
This guideline is based upon FDA’s August 2003 Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and Application and satisfies the criteria of 21 CFR Part 11, § 11.1 (a) “The regulations in this part set forth the criteria under which the agency considers e-records, e-signatures, and handwritten signatures executed to e-records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper”.

This guideline also harmonizes with PIC/S Guide for good manufacturing practice for medicinal products, Annex 11 “Computerised Systems” (as adopted in Canada).

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