Medical gases regulation

The adequacy of these connections has been demonstrated through their extensive safe use since 1959 when they were first approved by CGA. CGA E-7, American National and CGA Standard for Medical Gas Regulators and Flowmeters, was first published in 1983 [6]. This CGA standard specifies that, where applicable, connections to these components be in accordance with CGA V-5 [5]. The DISS concept formed the basis for the new series of high pressure, ultra-high integrity cylinder valve outlet connections for electronic gases. 

CGA E-7, American National and CGA Standardfor Medical Gas Regulators and Flowmeters, 2" ed.. Compressed Gas Association, Inc., 1725 Jefferson Davis Highway, Arlington, VA 22202. 

These federal agencies inspect registered facilities on a routine basis to assure compliance with the regulations. Failure to comply can result in possible halting of production, seizure of product, and penalties or fines and/or imprisonment. For more details on medical gas regulations, refer to Chapter 2. 

V-5 Diameter Index Safety System. Describes a standard to provide noninterchangeable connections where removable exposed threaded connections are employed in conjunction with individual gas lines of medical gas administering equipment at pressures of 200 psig or less, such as outlets from medical gas regulators and connectors for anesthesia, resuscitation, and therapy apparatus. Detailed dimensioned drawings are included. In addition to the medical gases covered by the Pin Index Safety System, this standard includes air and suction. (20 pages)... 

Use of the medical grade gas is by prescription only, and regulated by the FDA. Compressed medical gas suppliers must register with FDA, and are subjected to facility inspections from FDA at least once every two years. Licenses required to purchase and administer nitrous oxide in the healthcare setting is regulated on a state level. 

In Canada, the TDG Regulations of TC will apply [7]. Identification of the contents of portable medical gas containers must be as laid out in CGSB 24.2-M86, Identification of Medical Gas Containers, Pipelines, and Valves [10]. 

In Canada, oxygen USP must be manufactured, filled and handled in accordance with the Food and Drug Act and Regulations of Health and Welfare Canada and the Canadian General Standards Board Standard for Identification of Medical Gas Containers, Pipelines and Valves. [4]... 

Certain types of equipment are specifically excluded from the scope of the directive. It is self-evident that equipment which is already regulated at Union level with respect to the pressure risk by other directives had to be excluded. That is the case with simple pressure vessels, transportable pressure equipment, aerosols and motor vehicles. Other equipment, such as carbonated drink containers or radiators and piping for hot water systems are excluded from the scope because of the limited risk involved. Also excluded are products which are subject to a minor pressure risk which are covered by the directives on machinery, lifts, low voltage, medical devices, gas appliances and on explosive atmospheres. A further and last group of exclusions refers to equipment which presents a significant pressure risk, but for which neither the free circulation aspect nor the safety aspect necessitated their inclusion. 

Nitrous oxide is not a U.S. Drug Enforcement Administration controlled substance. Nitrous oxide is regulated at the federal level by the United States Food and Dmg Administration (FDA), as a food-grade propellant, medical grade gas, and prescription drug. In the... 

Figure 8 Simplified diagram of a signaling cascade that involves NE, BDNF, and CREB after NE acts on the postsynaptic fi-noradrenergic receptor. NE couples to a G protein (Gas), which stimulates the production of cAMP from adenosine triphosphate (ATP). This reaction is catalyzed by adenylate cyclase (AC). cAMP activates protein kinase A (PKA). Inside the cell, PKA phosphorylates (P) the CREB protein, which binds upstream from specific regions of genes and regulates their expression. BDNF is one target of cAMP signaling pathways in the brain. CRE, cyclic AMP regulatory element ER, endoplasmic reticulum, [reprinted from Reference 76 with permission of the author and the publisher, Canadian Medical Association].

Do not eat, drink or smoke when using this product. Wash hands thoroughly after handling. Do not breathe dust/fume/gas/mist/vapours/spray. Get medical attention/advice if you feel unwell. Dispose of contents/container to.... .. (in accordance with local/regional/national/intemational regulation). 

---