CAN CSA-Z18778-2008 Respiratory equipment - Infant monitors - Particular requirements (First Edition).pdf

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1、 Reference numberISO 18778:2005(E)ISO 2005INTERNATIONAL STANDARD ISO18778First edition2005-02-15Respiratory equipment Infant monitors Particular requirements Matriel respiratoire Moniteurs pour enfants Exigences particulires National Standard of CanadaCAN/CSA-Z18778-08International Standard ISO 1877

2、8:2005 (first edition, 2005-02-15) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z18778-08, which has been approved as a National Standard ofCanada by the Standards Council of Canada.ISBN 978-1-55436-709-2 February 2008International Organization for Standardization (ISO), 20

3、05. All rights reserved. NOT FOR RESALE.Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and int

4、erests 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, or verify the content of standards.Disclaimer and exclusion of liabilityThis document is provided witho

5、ut any representations, warranties, or conditions of any kind, express or implied, including, without limitation, implied warranties or conditions concerning this documents fitness for a particular purpose or use, its merchantability, or its non-infringement of any third partys intellectual property

6、 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 compliance with any applicable statute, rule, or regulation. IN NO EVENT SHALL CSA, ITS VOLUNTEERS, MEMBERS,

7、 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, INCLUDING BUT NOT LIMITED TO SPECIAL OR CONSEQUENTIAL DAMAGES, LOST REVENUE, BUSINESS INTERRUPTION, LOST

8、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 POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJU

9、RY, 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 perform any duty owed by any person or entity to another person or entity. The information in this document is

10、 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 on the information contained in this document. CSA is a private not-for-profit company that publishes vo

11、luntary 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 rights and ownershipAs between CSA and the users of this document (whether it be in printed or electronic

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13、ts 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 others intellectual property and may give rise to a right in CSA and/or others to seek legal redress for

14、 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 the possibility that some of the elements of this standard may be the subject of patent rights. CSA shall n

15、ot 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 own responsibility.Authorized use of this documentThis document is being provided by CSA for informational

16、 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 reviewing it;.search and browse this document; and.print this document. Limited copies of this document in

17、 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 not permit others to.alter this document in any way or remove this Legal Notice from the attached standard

18、;.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 not load or use this document or make any copies of the contents hereof, and if you do make such copies, y

19、ou 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-Z18778-08February 2008Title: Respiratory equipment Infant monitors Particular requirementsPagination: 36 pages (CSA/1CSA/4, i

20、vi, and 26 text)To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2418784.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-

21、2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we 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 N

22、ational Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary 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 professi

23、onal organizations, and governmental agencies. The standards are used widely by 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, c

24、ompanies, and associations across Canada indicate their support for CSAs standards 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 member

25、ships together form CSAs total membership from which its Directors are chosen. Sustaining 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

26、 activities. To ensure the integrity of its certification process, the Association 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 inspe

27、ction and testing agencies in eight countries. Since 1919, the Association has developed 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 ser

28、vices through the use of standards, certification and related services to meet national 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 theco

29、ordinating body of the National StandardsSystem, a coalition of independent, autonomousorganizations 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 me

30、ansof advancing the national economy, benefiting thehealth, safety, and welfare 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 standardprepar

31、ed or reviewed by an accredited Standards Development Organization (SDO) and approved 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

32、of capable individuals whose collective interests provide, to the greatest practicable 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 stan

33、dard which is capable of making a significant and timely contribution to the national 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 s

34、tandard.The responsibility for approving standards as National Standards of Canada 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

35、 Standard is stated in its Scope, it is importantto note that it remains the responsibility 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 February

36、 2008 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z18778-08Respiratory equipment Infant monitors Particular requirementsRegist

37、ered trade-mark of Canadian Standards AssociationReviewed byPrepared byInternational Organization for StandardizationCAN/CSA-Z18778-08 Respiratory equipment Infant monitors Particular requirementsFebruary 2008 Canadian Standards Association CSA/3CAN/CSA-Z18778-08Respiratory equipment Infant monitors

38、 Particular requirementsCSA PrefaceThis is the first edition of CAN/CSA-Z18778, Respiratory equipment Infant monitors Particular requirements, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 18778 (first edition,

39、 2005-02-15). This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Respiratory Technology, under the jurisdiction of the CSA Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the Strategic Steering Committee on Health Care Te

40、chnology, 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.February 2008 Canadian Standards Association 2008All rights reserved. No part of this publication may be reproduced in any form wha

41、tsoever without the prior permission of the 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 regarding this National Standard of Canada should be addresse

42、d 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-free 1-800-463-6727 or 416-747-4044.CAN/CSA-Z18778-08 Re

43、spiratory equipment Infant monitors Particular requirementsCSA/4 Canadian Standards Association February 2008Canadian deviations2 Normative referencesAdd the followingCSA (Canadian Standards Association)The following National Standards of Canada, published by the Canadian Standards Association, are

44、adoptions of IEC and ISO Standards. The requirements of these CSA Standards shall take precedence over the International Standards on which they are based; any reference in CAN/CSA-Z18778 to the International Standard shall be replaced by a reference to the equivalent Canadian Standard.CAN/CSA-C22.2

45、 No. 601.1-M90 (R2005)Medical electrical equipment Part 1: General requirements for safetyCAN/CSA-C22.2 No. 60529:05Degrees of protection provided by enclosures (IP Code) CAN/CSA-C22.2 No. 60601-1-2:03 Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electr

46、omagnetic compatibility Requirements and testsCAN/CSA-C22.2. No. 60601-1-6:05Medical electrical equipment Part 1-6: General requirements for safety Collateral standard: UsabilityCAN/CSA-C22.2 No. 60601-1-8:05Medical electrical equipment Part 1-8: General requirements for safety Collateral standard:

47、General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsCAN/CSA-C22.2 No. 60601-2-23:02Medical electrical equipment Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure

48、monitoring equipmentCAN/CSA-C22.2 No. 60601-2-27:06Medical electrical equipment Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipmentCAN/CSA-ISO 14971:07Medical devices Application of risk management to medical devicesCAN/CSA

49、-Z9919-07Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical useReference numberISO 18778:2005(E)ISO 2005INTERNATIONAL STANDARD ISO18778First edition2005-02-15Respiratory equipment Infant monitors Particular requirements Matriel respiratoire Moniteurs pour enfants Exigences particulires ISO 18778:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing polic

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