CGA-G-8.2-2007.pdf
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1、 CGA G-8.22007 COMMODITY SPECIFICATION FOR NITROUS OXIDE FIFTH EDITION COMPRESSED GAS ASSOCIATION, INC. 4221 Walney Road, 5th Floor Chantilly, VA 20151 Phone: 703-788-2700 Fax: 703-961-1831 E-mail: PAGE ii COMPRESSED GAS ASSOCIATION, INC. CGA G-8.22007 PLEASE NOTE: The information contained in this
2、 document was obtained from sources believed to be reliable and is based on technical information and experience currently available from members of the Compressed Gas Association, Inc. and others. However, the Association or its members, jointly or severally, make no guarantee of the results and as
3、sume no liability or responsibility in connection with the information or suggestions herein contained. Moreover, it should not be assumed that every acceptable commodity grade, test or safety procedure or method, precaution, equipment or device is contained within, or that abnormal or unusual circu
4、mstances may not warrant or suggest further requirements or additional procedure. This document is subject to periodic review, and users are cautioned to obtain the latest edition. The Associa- tion invites comments and suggestions for consideration. In connection with such review, any such comments
5、 or suggestions will be fully reviewed by the Association after giving the party, upon request, a reasonable op- portunity to be heard. Proposed changes may be submitted via the Internet at our web site, . This document should not be confused with Federal, state, provincial, or municipal specificati
6、ons or regulations; insurance requirements; or national safety codes. While the Association recommends reference to or use of this document by government agencies and others, this document is purely voluntary and not binding. A listing of all publications, audiovisual programs, safety and technical
7、bulletins, and safety posters is available via the Internet at our website at . For more information contact CGA at Phone: 703-788-2700, ext. 799. E-mail: . Work Item 05-18 Medical Gases and Equipment Committee NOTETechnical changes from the previous edition are underlined. FIFTH EDITION: 2007 FOURT
8、H EDITION: 2000 THIRD EDITION: 1994 SECOND EDITION: 1989 2007 BY THE COMPRESSED GAS ASSOCIATION, INC. All materials contained in this work are protected by United States and international copyright laws. No part of this work may be reproduced or transmitted in any form or by any means, electronic or
9、 mechanical including photocopying, recording, or any informa- tion storage and retrieval system without permission in writing from The Compressed Gas Association, Inc. All requests for permission to reproduce material from this work should be directed to The Compressed Gas Association, Inc., 4221 W
10、alney Road, Suite 500, Chantilly VA 20151. You may not alter or remove any trademark, copyright or other notice from this work. CGA G-8.22007 COMPRESSED GAS ASSOCIATION, INC. PAGE iii Contents Page 1 Scope .1 2 Classification 1 2.1 Types.1 2.2 Quality verification levels.1 2.3 Quality tests.1 3 Qual
11、ity verification systems3 3.1 Production qualification tests.3 3.2 Lot acceptance tests3 4 Sampling 4 4.1 Sample size.4 4.2 Gaseous samples4 4.3 Liquid samples.4 5 Analytical procedures.5 5.1 Parameters of analysis5 5.2 Ammonia content.6 5.3 Carbon dioxide content6 5.4 Carbon monoxide content .6 5.5
12、 Halogen content 7 5.6 Hydrocarbon content (C1-C5).7 5.7 Nitrogen content7 5.8 Nitrogen and oxygen (air) content.7 5.9 Nitrogen oxides content (NO and NO2) .7 5.10 Oxygen content .7 5.11 Percent nitrous oxide.8 5.12 Water content8 5.13 Identity.8 6 Containers8 6.1 Nitrous oxide containers8 6.2 Conta
13、iner preparation9 6.3 Nitrous oxide (USP).9 6.4 Valves on nitrous oxide containers9 7 Supplemental specification data.10 7.1 Moisture conversion data 10 7.2 Assay conversion data 12 8 References.12 Tables Table 1Directory of limiting characteristics (units in ppm (v/v) unless otherwise shown)2 Table
14、 2Typical uses.2 Table 3Moisture conversion data 10 Table 4Assay conversion data 12 -,-,- This page is intentionally blank. -,-,- CGA G-8.22007 COMPRESSED GAS ASSOCIATION, INC. PAGE 1 1 Scope This publication describes the specification requirements for nitrous oxide manufactured by various commerci
15、al processes. The term container as used in this publication shall refer to portable compressed gas cylinders and liquid containers made in accordance with Title 49 of the U.S. Code of Federal Regulations (49 CFR) Parts 100-180; Transport Canadas (TC) Transportation of Dangerous Goods Regulations; o
16、r ASME Boiler whereas contaminants such as nitrogen dioxide, ammonia, and chlorine are concentrated in the liquid phase. It is therefore important that a two-phase sample be analyzed in an analytical sequence that will not materially reduce contaminants to be determined in subsequent procedures. The
17、 analytical proce- dures are listed in a sequence that will minimize concentration changes. Analytical sequence may be altered as agreed to by the supplier and the customer for non-USP nitrous oxide. 2) Unless otherwise specified, the sample shall be obtained from the vapor phase of the container or
18、 as agreed to by the sup- plier and the customer. 3) For USP quality verification, the percent nitrous oxide shall be defined as the difference between 100% and the percent air. This test is performed last in the sequence of USP tests after all other trace constituents have been determined. 4) For U
19、SP quality verification, perform the verification tests in the sequence listed (after the filled container has warmed to ambient temperature); a gas/liquid equilibrium must be established in the container. For a vapor sample, test nitrous oxide gas from the vapor phase of the container; for a liquid
20、 sample, a representative vaporized sample of the liquid phase must be obtained. The sequence listed minimizes concentration changes and allows for maximum detection of toxic contami- nants on the assumption that the usage is inhalation. Table 2Typical uses Quality verification level (QVL) Typical u
21、ses A Medical/USP B General commercial uses C Semiconductor NOTETypical uses defined in this table are not all-inclusive. -,-,- CGA G-8.22007 COMPRESSED GAS ASSOCIATION, INC. PAGE 3 3 Quality verification systems 3.1 Production qualification tests These tests are a single test or a series of analyse
22、s performed on the product to ensure the reliability of the production facility to supply nitrous oxide of the required QVL. This production qualification can be verified by the analytical records of product from the supplier or, if required, by the analysis of representative samples of the product
23、from the facility at appropriate intervals as agreed to by the supplier and the customer. Production qualification tests can be performed by the supplier or by a laboratory agreed to by the supplier and the cus- tomer. 3.1.1 Analytical requirements of the production qualification tests Analytical re
24、quirements of the production qualification tests include the determination of all the limiting charac- teristics of nitrous oxide. 3.1.2 Compliance with U.S. Pharmacopeia and National Formulary To comply with the General Notices requirements of the U.S. Pharmacopeia and National Formulary (USPNF), t
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