1、Reference numberISO 9360-1:2000(E)ISO 2000Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) forhumidifying respired gases in humans Part 1:HMEs for use with minimum tidal volumesof 250 mlMatriel danesthsie et de ranimation respiratoire changeurs dechaleur et dhumidit (ECH) ut
2、iliss pour humidifier les gaz respirs parles tres humains Partie 1: ECH pour utilisation avec des volumes courants dau moins250 mlNational Standard of CanadaCAN/CSA-Z9360-1-07International Standard ISO 9360-1:2000 (first edition, 2000-03-15) has been adopted with Canadiandeviations (MOD) as CSA Stan
3、dard CAN/CSA-Z9360-1-07, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 1-55436-207-5 March 2007Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the St
4、andards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensus and develop a standard. Although CSA administers the process and establishes rules to promote fairness in achieving consensus, it does not independently test, evaluate
5、, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided without any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning this documents fitness for a particul
6、ar purpose or use, its merchantability, or its non-infringement of any third partys intellectual property rights. CSA does not warrant the accuracy, completeness, or currency of any of the information published in this document. CSA makes no representations or warranties regarding this documents com
7、pliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OR OFFICERS, BE LIABLE FOR ANY DIRECT, INDIRECT, OR INCIDENTAL DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED,
8、INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST OR DAMAGED DATA, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OF LIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR
9、POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA is not undertaking to render professional or other services for or on behalf of any person or entity or to perfo
10、rm any duty owed by any person or entity to another person or entity. The information in this document is directed to those who have the appropriate degree of experience to use and apply its contents, and CSA accepts no responsibility whatsoever arising in any way from any and all use of or reliance
11、 on the information contained in this document. CSA is a private not-for-profit company that publishes voluntary standards and related documents. CSA has no power, nor does it undertake, to enforce compliance with the contents of the standards or other documents it publishes. Intellectual property r
12、ights and ownershipAs between CSA and the users of this document (whether it be in printed or electronic form), CSA is the owner, or the authorized licensee, of all works contained herein that are protected by copyright, all trade-marks (except as otherwise noted to the contrary), and all inventions
13、 and trade secrets that may be contained in this document, whether or not such inventions and trade secrets are protected by patents and applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate laws that protect CSAs and/or
14、 others intellectual property and may give rise to a right in CSA and/or others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectual property rights in this document.Patent rightsAttention is drawn to th
15、e possibility that some of the elements of this standard may be the subject of patent rights. CSA shall not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any such patent rights is entirely their o
16、wn responsibility.Authorized use of this documentThis document is being provided by CSA for informational and non-commercial use only. The user of this document is authorized to do only the following:If this document is in electronic form:.load this document onto a computer for the sole purpose of r
17、eviewing it;.search and browse this document; and.print this document. Limited copies of this document in print or paper form may be distributed only to persons who are authorized by CSA to have such copies, and only if this Legal Notice appears on each such copy.In addition, users may not and may n
18、ot permit others to.alter this document in any way or remove this Legal Notice from the attached standard;.sell this document without authorization from CSA; or.make an electronic copy of this document.If you do not agree with any of the terms and conditions contained in this Legal Notice, you may n
19、ot load or use this document or make any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and conditions of this Legal Notice.Standards Update ServiceCAN/CSA-Z9360-1-07March 2007
20、Title: Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 mLPagination:28 pages (CSA/1CSA/4, iv, and 19 text)To register for e-mail notification about any updates to this publicatio
21、ngo on-line to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2417873.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we
22、 protect your personal information.The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntar
23、y membership association engaged in standards development and certification activities. CSA standards reflect a national consensus of producers and users including manufacturers, consumers, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by
24、industry and commerce and often adopted by municipal, provincial, and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and the environment. Individuals, companies, and associations across Canada indicate their support for CSAs standar
25、ds development by volunteering their time and skills to CSA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteers and the 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. S
26、ustaining memberships represent a major source of income for CSAs standards development activities. The Association offers certification and testing services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, the Associati
27、on regularly and continually audits and inspects products that bear the CSA Mark. In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, the Association has d
28、eveloped the necessary expertise to meet its corporate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet n
29、ational and international needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada (SCC) is thecoordinating body of the National StandardsSystem, a coalition of independent, aut
30、onomousorganizations working towards the furtherdevelopment and improvement of voluntarystandardization in the national interest.The principal objects of the SCC are to fosterand promote voluntary standardization as a meansof advancing the national economy, benefiting thehealth, safety, and welfare
31、of the public, assistingand protecting the consumer, facilitating domesticand international trade, and furthering internationalcooperation in the field of standards.A National Standard of Canada (NSC) is a standardprepared or reviewed by an accredited Standards Development Organization (SDO) and app
32、roved by the SCC according to the requirements of CAN-P-2. Approval does not refer to the technical content of the standard; this remains the continuing responsibility of the SDO. An NSC reflects a consensus of a number of capable individuals whose collective interests provide, to the greatest pract
33、icable extent, a balance of representation of general interests, producers, regulators, users (including consumers), and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant and timely contribution to the nat
34、ional interest.Those who have a need to apply standards areencouraged to use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SDO which publishes the standard.The responsibility for approving standards as National Standards of Cana
35、da rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme nationale du Canada est offerte en anglais et en franais.Although the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the res
36、ponsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in March 2007 by Canadian Standards AssociationA not-for-profit private sector organization
37、5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z9360-1-07Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum
38、tidalvolumes of 250 mLRegistered trade-mark of Canadian Standards AssociationReviewed byPrepared byInternational Organization for StandardizationCAN/CSA-Z9360-1-07Anaesthetic and respiratory equipment Heat and moistureexchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use wi
39、th minimum tidal volumes of 250 mLMarch 2007 Canadian Standards Association CSA/3CAN/CSA-Z9360-1-07Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 mLCSA PrefaceThis is the first
40、edition of CAN/CSA-Z9360-1, Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 mL, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organ
41、ization for Standardization) Standard 9360-1 (first edition, 2000-03-15). This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Respiratory Technology, under the jurisdiction of the Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipmen
42、t and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. March 2007 Canadian Standards Association 2007All rights reserved. No part
43、 of this publication may be reproduced in any form whatsoever without the prior permission ofthe publisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text, they should be interpreted as “this National Standard of Canada”.Inquiries regardin
44、g this National Standard of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4000www.csa.caTo purchase CSA Standards and related publications, visit CSAs Online Store at www.ShopCSA.ca or call toll-fre
45、e1-800-463-6727 or 416-747-4044.CAN/CSA-Z9360-1-07Anaesthetic and respiratory equipment Heat and moistureexchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 mLCSA/4 Canadian Standards Association March 2007Canadian deviations2 Normative r
46、eferencesAdd the followingThe following National Standard of Canada, published by the Canadian Standards Association, is an adoption of an IEC Standard. The requirements of this CSA Standard shall take precedence over the International Standard on which they are based; any reference in CAN/CSA-Z9360
47、-1 to the International Standard shall be replaced by a reference to the equivalent Canadian Standard.CAN/CSA-C22.2 No. 601.1-M90 (R2005)Medical electrical equipment Part 1: General requirements for safety7 Marking7.1 Replace Item (b) with the following(b) the letters APG (explained in CAN/CSA-C22.2
48、 No. 601.1) if the manufacturer states that the HME is safe for use with flammable anaesthetics.Reference numberISO 9360-1:2000(E)ISO 2000INTERNATIONALSTANDARDISO9360-1First edition2000-03-15Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) forhumidifying respired gases in hu
49、mans Part 1:HMEs for use with minimum tidal volumesof 250 mlMatriel danesthsie et de ranimation respiratoire changeurs dechaleur et dhumidit (ECH) utiliss pour humidifier les gaz respirs parles tres humains Partie 1: ECH pour utilisation avec des volumes courants dau moins250 mlISO 9360-1:2000(E)PDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but sh
