CAN CSA-Z7376-2012 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (Second Edition).pdf

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1、Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubationCAN/CSA-Z7376:12(ISO 7376:2009, MOD)National Standard of CanadaNOT FOR RESALE. / PUBLICATION NON DESTINE LA REVENTE.Legal Notice for StandardsCanadian Standards Association (CSA) standards are developed through a consensus st

2、andards development process approved by the Standards 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 conse

3、nsus, it does not independently test, evaluate, 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 co

4、ncerning this documents fitness for a particular 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 representati

5、ons or warranties regarding this documents compliance 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

6、, LOSS, COSTS, OR EXPENSES, HOWSOEVER CAUSED, 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,

7、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, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document available, CSA is not undertaking to render professional or other services for or

8、 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 directed to those who have the appropriate degree of experience to use and apply its contents, and CSA accepts no responsibility whatsoever arising

9、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 voluntary standards and related documents. CSA has no power, nor does it undertake, to enforce compliance with the contents of the standards or other d

10、ocuments it publishes. Intellectual property rights 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 otherw

11、ise noted to the contrary), and all inventions 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 docu

12、ment 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 such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA reserves all intellectual property rights in this

13、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 not be held responsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity

14、 of any such patent rights is entirely their own 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 docu

15、ment onto a computer for the sole purpose of reviewing it;.search and browse this document; and.print this document if it is in PDF format. 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

16、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;.sell this document without authorization from CSA; or.make an electronic copy of this document.If you do not agree with any

17、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, you are required to destroy them immediately. Use of this document constitutes your acceptance of the terms and conditions of t

18、his Legal Notice.CSA Standards Update ServiceCAN/CSA-Z7376:12October 2012Title: Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubationPagination: 37 pages (CSA/1CSA/5, iv, and 27 text)To register for e-mail notification about any updates to this publicationgo on-line to shop.csa

19、.caclick on E-mail Services under MY ACCOUNTclick on CSA Standards Update ServiceThe List ID that you will need to register for updates to this publication is 2421786.If you require assistance, please e-mail techsupportcsa.ca or call 416-747-2233.Visit CSAs policy on privacy at csagroup.org/legal to

20、 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 National Standards system in 1973. It is a not-for-profit, nonsta

21、tutory, 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 professional organizations, and governmental agencies. The standards are

22、 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, companies, and associations across Canada indicate their support

23、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 memberships together form CSAs total membership from which its Directo

24、rs 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 activities. To ensure the integrity of its certification proces

25、s, 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 inspection and testing agencies in eight countries. Since 1919, the A

26、ssociation 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 services through the use of standards, certification and related se

27、rvices 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 thecoordinating body of the National StandardsSystem, a coalition of

28、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 meansof advancing the national economy, benefiting thehealth, safe

29、ty, 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 standardprepared or reviewed by an accredited Standards Development Organizati

30、on (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 of capable individuals whose collective interests provide, to th

31、e 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 standard which is capable of making a significant and timely contrib

32、ution 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 standard.The responsibility for approving standards as National S

33、tandards 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 Standard is stated in its Scope, it is importantto note that it

34、 remains the responsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationReviewed byNational Standard of CanadaPublished in October 2012 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spec

35、trum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at shop.csa.caPrepared byInternational Organization for StandardizationApproved byStandards Council of CanadaCAN/CSA-Z7376:12Anaesthetic and respiratory equipment Laryngoscopes for tracheal int

36、ubationCAN/CSA-Z7376:12Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubationCSA/4 Canadian Standards Association October 2012CAN/CSA-Z7376:12Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubationCSA PrefaceThis is the second edition of CAN/CSA-Z7376, Anaest

37、hetic and respiratory equipment Laryngoscopes for tracheal intubation, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 7376 (second edition, 2009-08-15). It supersedes the previous edition published in 2007 as CA

38、N/CSA-Z7376 (adopted ISO 7376:2003).This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Perioperative Safety, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Stand

39、ard has been approved as a National Standard of Canada by the Standards Council of Canada.October 2012 Canadian Standards Association 2012All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted

40、 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 addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ont

41、ario, Canada L4W 5N61-800-463-6727 416-747-4000http:/csa.caTo purchase CSA Standards and related publications, visit CSAs Online Store at shop.csa.ca or call toll-free 1-800-463-6727 or 416-747-4044.CSA Standards are subject to periodic review, and suggestions for their improvement will be referred

42、to the appropriate committee. To submit a proposal for change to CSA Standards, please send the following information to inquiriescsa.ca and include “Proposal for change” in the subject line:(a) Standard designation (number);(b) relevant clause, table, and/or figure number;(c) wording of the propose

43、d change; and(d) rationale for the change.CAN/CSA-Z7376:12Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubationOctober 2012 Canadian Standards Association CSA/5Canadian deviations2 Normative referencesAdd the followingThe following National Standard of Canada, published by the

44、Canadian Standards Association, is an adoption of an IEC Standard. The requirements of the CSA Standard shall take precedence over the International Standard on which it is based; any reference in CAN/CSA-Z7376 to the International Standard shall be replaced by a reference to the equivalent Canadian

45、 Standard.CSA (Canadian Standards Association)CAN/CSA-C22.2 No. 60601-1:08Medical electrical equipment Part 1: General requirements for basic safety and essential performanceAnnex E (informative)Rationale for inclusion of certain requirementsClause 11, item m)Replace this clause with the followingAt

46、tention is drawn to the requirement in CAN/CSA-C22.2 No. 60601-1 that the temperature of equipment parts that can, in normal use, have a brief contact with a patient shall not exceed 50 C, which can be applicable to lamps in conventional laryngoscopes unless other protective means are provided.Refer

47、ence numberISO 7376:2009(E)ISO 2009INTERNATIONAL STANDARD ISO7376Second edition2009-08-15Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation Matriel danesthsie et de ranimation respiratoire Laryngoscopes pour intubation trachale ISO 7376:2009(E) PDF disclaimer This PDF file m

48、ay contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the res

49、ponsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at

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