ANSI AAMI 11195-1995 Gas mixers for medical use-Stand-alone gas mixers.pdf

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1、ANSI/AAMI/ISO 11195: 1995Gas mixers for medical useStand-alone gas mixers American National StandardThis document was approved and published when the U.S. TAG for TC 121 was held by ASTM, but it is now an AAMI standard. The original formatting has been maintained, so there are some variations from t

2、he typical AAMI style. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2014 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright cl

3、aims of ISO, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 10

4、1, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per o

5、ffense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: 703-525-4890; Fax: 703-525-1067. Printed in the United States of America ISBN 1570205299

6、 ANS/ISO 11195 1995Gas mixers for medical use Stand-alone gas mixers Approved as an American National Standard with deviations by: ASTM International These materials are subject to copyright claims of ISO, ANSI, and ASTM International. Not for resale without the prior written permission of ASTM Inte

7、rnational. No part of this publication may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASTM International. ASTM Deviations to ISO 11195: 1995 Clause 2 - Normative references Delete the following: ISO 32:1977, Gas cylinders for medical

8、use Marking for identification of content. ISO 5359:1989, Low-pressure flexible connecting assemblies (hose assemblies) for use with medical gas systems. ISO 7767: 1988, Oxygen analyzers for monitoring patient breathing mixtures - Safety requirements.Add the following: CGA C-9: 1993 Standard color m

9、arking of compressed gas containers intended for medical use. ASTM/ISO 5359:2003, Low-pressure flexible connecting assemblies (hose assemblies) for use with medical gas systems. ASTM/ISO 7767:2002, Oxygen analyzers for monitoring patient breathing mixtures - Safety requirements. Rationale for ASTM I

10、nternational Deviations:CGA C-9 contains the medical gas color code used in the United States, which is different from the medical gas color code established by ISO 32.ASTM/ISO 5359:2003 is the recent adoption by ASTM International of the most current edition of ISO 5359. The ASTM International adop

11、tion of ISO 5359 includes deviations to reflect the requirements of low-pressure hose assemblies for use with medical gases in the United States. ASTM/ISO 7767:2002 is the recent adoption by ASTM International of the most current edition of ISO 7767. The ASTM International adoption of ISO 7767 inclu

12、des deviations to reflect the requirements of oxygen analyzers for monitoring patient breathing mixtures-safety requirements in the United States. Clause 4 Gas Connectors Delete the following: Gas inlet connectors shall be gas-specific and shall be either screw-threaded (i.e. NIST or DISS) or quick-

13、connect; they shall comply with ISO 5359. NOTE 1-The outlet connector is not specified because of the diversity of application of gas mixers. Add the following: Gas inlet connectors shall be gas-specific and comply with the applicable requirements of ASTM/ISO 5359:2003. If screw-threaded, the gas in

14、let connectors shall be DISS. NOTE 1-The outlet connector is not specified because of the diversity of application of gas mixers. Rationale for ASTM International Deviation: NIST connectors are not used in the United States. Clause 10 Low-pressure flexible connecting hose assemblies Delete the follo

15、wing: All external, operator-detachable inlet low-pressure hose assemblies supplied with the gas mixer shall comply with ISO 5359. Add the following: All external, operator-detachable low-pressure hose assemblies supplied with the gas mixer shall comply with ASTM/ISO 5359:2003. Rationale for ASTM In

16、ternational Deviation: ASTM/ISO 5359:2003 is the recent adoption by ASTM International of the most current edition of ISO 5359. The ASTM International adoption of ISO 5359 includes deviations to reflect the requirements of low-pressure hose assemblies for use with medical gases in the United States.

17、 Clause 14.1 - Marking Delete the following: Each gas inlet shall be clearly and durably marked with the name or the chemical symbol of the gas in accordance with ISO 5359. If colour coding is used in addition, the colour shall be in accordance with ISO 32. Add the following: Each gas inlet shall be

18、 clearly and durably marked with the name or the chemical symbol of the gas in accordance with ASTM/ISO 5359:2003. If color coding is used in addition, the color shall be in accordance with CGA C-9:1993. Rationale for ASTM International Deviation: CGA C-9 contains the medical gas color code used in

19、the United States, which is different from the medical gas color code established by ISO 32.ASTM/ISO 5359:2003 is the recent adoption by ASTM International of the most current edition of ISO 5359. The ASTM International adoption of ISO 5359 includes deviations to reflect the requirements of low-pres

20、sure hose assemblies for use with medical gases in the United States. Clause 14.5 - Markings Delete the following: The concentration adjustment control(s) or its surroundings shall be clearly and permanently marked in accordance with ISO 5359 with the names or chemical symbols of the gases being mix

21、ed. If colour coding is used in addition to identify the gases, the colours shall be in accordance with ISO 32. Add the following: The concentration adjustment control(s) or its surroundings shall be clearly and permanently marked in accordance with ASTM/ISO 5359:2003 with the name or chemical symbo

22、l of the gases being mixed. If color coding is used in addition to identify the gases, the colors shall be in accordance with CGA C-9:1993. Rationale for ASTM International Deviation:CGA C-9 establishes the medical gas color code used in the United States, which is different than the medical gas col

23、or code established by ISO 32.ASTM/ISO 5359:2003 is the recent adoption by ASTM International of the most current edition of ISO 5359. The ASTM International adoption of ISO 5359 includes deviations to reflect the requirements of low-pressure hose assemblies for use with medical gases in the United

24、States. Figure 1- Example of test arrangement for checking oxygen concentration of delivered gas In the “Key“ - Delete the following: 6 Oxygen monitor complying with ISO 7767 Add the following: 6 Oxygen monitor complying with ASTM/ISO 7767:2002 Rationale for ASTM International Deviation:ASTM/ISO 776

25、7:2002 is the recent adoption by ASTM International of the most current edition of ISO 7767. The ASTM International adoption of ISO 7767 includes deviations to reflect the requirements of oxygen analyzers for monitoring patient breathing mixtures-safety requirements in the United States. Clause 15.2

26、 Item i) Technical documentation Delete the following: a statement that all operator-detachable inlet pressure hoses supplied with the gas mixer comply with ISO 5359; Add the following: a statement that all operator-detachable inlet pressure hoses supplied with the gas mixer comply with ASTM/ISO 535

27、9:2003; Rationale for ASTM International Deviation:ASTM/ISO 5359:2003 is the recent adoption by ASTM International of the most current edition of ISO 5359. The ASTM International adoption of ISO 5359 includes deviations to reflect the requirements of low-pressure hose assemblies for use with medical gases in the United States. ASTM International 100 Barr Harbor Drive PO BoxC70West Conshohocken, PA 19428-2959 Phone: 610-832-9685 Fax: 610-832-9555 e-mail serviceastm.org website: www.astm.org