ImageVerifierCode 换一换
格式:PDF , 页数:25 ,大小:2.42MB ,
资源ID:430275      下载积分:5000 积分
快捷下载
登录下载
邮箱/手机:
温馨提示:
如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
如填写123,账号就是123,密码也是123。
特别说明:
请自助下载,系统不会自动发送文件的哦; 如果您已付费,想二次下载,请登录后访问:我的下载记录
支付方式: 支付宝扫码支付 微信扫码支付   
注意:如需开发票,请勿充值!
验证码:   换一换

加入VIP,免费下载
 

温馨提示:由于个人手机设置不同,如果发现不能下载,请复制以下地址【http://www.mydoc123.com/d-430275.html】到电脑端继续下载(重复下载不扣费)。

已注册用户请登录:
账号:
密码:
验证码:   换一换
  忘记密码?
三方登录: 微信登录  

下载须知

1: 本站所有资源如无特殊说明,都需要本地电脑安装OFFICE2007和PDF阅读器。
2: 试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。
3: 文件的所有权益归上传用户所有。
4. 未经权益所有人同意不得将文件中的内容挪作商业或盈利用途。
5. 本站仅提供交流平台,并不能对任何下载内容负责。
6. 下载文件中如有侵权或不适当内容,请与我们联系,我们立即纠正。
7. 本站不保证下载资源的准确性、安全性和完整性, 同时也不承担用户因使用这些下载资源对自己和他人造成任何形式的伤害或损失。

版权提示 | 免责声明

本文(ANSI AAMI 11195-1995 Gas mixers for medical use-Stand-alone gas mixers.pdf)为本站会员(boatfragile160)主动上传,麦多课文库仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文库(发送邮件至master@mydoc123.com或直接QQ联系客服),我们立即给予删除!

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

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

copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
备案/许可证编号:苏ICP备17064731号-1