CAN CSA-ISO 10079-2-2014 Medical suction equipment - Part 2 Manually powered suction equipment (Second Edition).pdf

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1、 ISO 2014. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 10079-2:14(ISO 10079-2:2014, IDT)National Standard of CanadaCAN/CSA-ISO 10079-2:14 Medical suction equipment Part 2: Manually powered suction equipment(ISO 10079-2:2014, IDT)Legal Notice for

2、StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards 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

3、 standard. Although CSA Group 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 without any representations, warranties,

4、 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 rights. CSA Group does not warrant

5、 the accuracy, completeness, or currency of any of the information published in this document. CSA Group makes no representations or warranties regarding this documents compliance with any applicable statute, rule, or regulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIARIES, OR

6、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 OR DAMAGED DATA, O

7、R 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 GROUP HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INJURY, LOSS, CO

8、STS, OR EXPENSES.In publishing and making this document available, CSA Group 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 direc

9、ted to those who have the appropriate degree of experience to use and apply its contents, and CSA Group accepts no responsibility whatsoever arising in any way from any and all use of or reliance on the information contained in this document.CSA Group is a private not-for-profit company that publish

10、es voluntary standards and related documents. CSA Group 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 Group and the users of this document (whether it be in printe

11、d or electronic form), CSA Group 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 and trade secrets that may be contained in this document, whether or not such inve

12、ntions 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 CSA Groups and/or others intellectual property and may give rise to a right in CSA Group and/o

13、r others to seek legal redress for such use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA Group 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 t

14、he subject of patent rights. CSA Group 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 own responsibility.Authorized use of this documentThis docum

15、ent is being provided by CSA Group 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 reviewing it; search and browse this document; and pri

16、nt 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 Group 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

17、 this document in any way or remove this Legal Notice from the attached standard; sell this document without authorization from CSA Group; 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

18、 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-ISO 10079-2:14September 2014Title: Medi

19、cal suction equipment Part 2: Manually powered suction equipmentTo register for e-mail notification about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2423308.If you require assistance, plea

20、se e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legalto find out how we protect your personal information.Canadian Standards Association (operating as “CSA Group”), under whose auspices this National Standard has been produced, was chartered

21、in 1919 and accredited by the Standards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards development and certification activities.CSA Group standards reflect a national consensus of producers and u

22、sers including manufacturers, consumers, retailers, unions and professional 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,

23、 safety, building and construction, and the environment.Individuals, companies, and associations across Canada indicate their support for CSA Groups standards development by volunteering their time and skills to Committee work and supporting CSA Groups objectives through sustaining memberships. The

24、more than 7000 committee volunteers and the 2000 sustaining memberships together form CSA Groups total membership from which its Directors are chosen. Sustaining memberships represent a major source of income for CSA Groups standards development activities.CSA Group offers certification and testing

25、services in support of and as an extension to its standards development activities. To ensure the integrity of its certification process, CSA Group regularly and continually audits and inspects products that bear the CSA Group Mark.In addition to its head office and laboratory complex in Toronto, CS

26、A Group has regional branch offices in major centres across Canada and inspection and testing agencies in eight countries. Since 1919, CSA Group has developed the necessary expertise to meet its corporate mission: CSA Group is an independent service organization whose mission is to provide an open a

27、nd effective forum for activities facilitating the exchange of goods and services through the use of standards, certification and related services to meet national and international needs.For further information on CSA Group services, write toCSA Group5060 Spectrum Way, Suite 100Mississauga, Ontario

28、, L4W 5N6CanadaThe Standards Council of Canada (SCC) is the coordinating body of the Canadian standardization network, which is composed of people and organizations involved in the development, promotion and implementation of standards. Through the collaborative efforts of Canadian standardization n

29、etwork members, standardization is helping to advance the social and economic well-being of Canada and to safeguard the health and safety of Canadians. The networks efforts are overseen by SCC.The principal objectives of SCC are to foster and promote voluntary standardization as a means of advancing

30、 the national economy, supporting sustainable development, benefiting the health, safety and welfare of workers and the public, assisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperation in relation to standardization.An important f

31、acet of the Canadian standards development system is the use of the following principles: consensus; equal access and effective participation by concerned interests; respect for diverse interests and identification of those who should be afforded access to provide the needed balance of interests; me

32、chanism for dispute resolution; openness and transparency; open access by interested parties to the procedures guiding the standards development process; clarity with respect to the processes; and Canadian interest consideration as the initial basis for the development of standards.A National Standa

33、rd of Canada (NSC) is a standard prepared or reviewed by an SCC-accredited SDO and approved by the SCC according to NSC approval requirements. Approval does not refer to the technical content of the standard, as this remains the responsibility of the SDO. An NSC reflects a consensus of a number of c

34、apable 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 at hand. NSCs are intended to make

35、a significant and timely contribution to the Canadian interest.Those who have a need to apply standards are encouraged to use NSCs. These standards are subject to periodic review. Users of NSCs are cautioned to obtain the latest edition from the SDO that publishes the standard.The responsibility for

36、 approving standards as NSCs rests withStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaCette Norme Nationale du Canada est disponible en versions franaise et anglaise.Although the intended primary application of this Standard is stated in its Scope, it is importa

37、nt to note that it remains the responsibility of the users to judge its suitability for their particular purpose.TMA trade-mark of the Canadian Standards Association, operating as “CSA Group”ICS 11.040.10ISBN 978-1-77139-589-2 2014 CSA GroupAll rights reserved. No part of this publication may be rep

38、roduced in any form whatsoever without the prior permission of the publisher.Published in September 2014 by CSA Group A not-for-profit private sector organization 5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N6 To purchase standards and related publications, visit our Online Store

39、 at shop.csa.caor call toll-free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S tandards Association,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved byMedical suction equipment Part 2: Manually powered suction equipment(ISO 10079

40、-2:2014, IDT)CAN/CSA-ISO 10079-2:14National Standard of CanadaCAN/CSA-ISO 10079-2:14Medical suction equipment Part 2: Manually powered suction equipmentSeptember 2014 2014 CSA GroupCSA/5CAN/CSA-ISO 10079-2:14Medical suction equipment Part 2: Manually powered suction equipment(ISO 10079-2:2014, IDT)C

41、SA PrefaceThis is the second edition of CAN/CSA-ISO 10079-2, Medical suction equipment Part 2: Manually powered suction equipment, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 10079-2 (third edition, 2014-05-01). It

42、 supersedes the previous edition published in 2003 as CAN/CSA-Z10079-2 (adopted ISO 10079-2:1999, with Canadian deviations).For brevity, this Standard will be referred to as “CAN/CSA-ISO 10079-2” throughout.This Standard was reviewed for Canadian adoption by the Standards Mirror Committee to ISO/TC

43、121, under the jurisdiction of the CSA Technical Committee on Perioperative Safety and the CSA Strategic Steering Committee on Health Care Technology Systems, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards

44、Council of Canada. 2014 CSA GroupAll 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 with permission. Where the words “this International Standard” appear in the text, they should be interp

45、reted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed to CSA Group5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada, L4W 5N61-800-463-6727 416-747-4000http:/csa.caTo purchase standards and related publications, visit our Online

46、Store at shop.csa.caor call toll-free 1-800-463-6727 or 416-747-4044.This Standard is subject to review five years from the date of publication, and suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information t

47、o inquiriescsagroup.organd include “Proposal for change” in the subject line:a) Standard designation (number);b) relevant clause, table, and/or figure number;c) wording of the proposed change; andd) rationale for the change.CSA Technical Committee on Perioperative SafetyS. Taylor London, OntarioCate

48、gory: General InterestChairM. Armutlu Jewish General Hospital, Montral, QubecCategory: User ManagementA. Bialachowski St. Josephs Healthcare Hamilton, Hamilton, OntarioCategory: User ManagementD.A. Chartrand Montreal Neurological Hospital, Montral, QubecCategory: Health Care ProfessionalJ.D. Deslaur

49、iers Health Canada, Ottawa, OntarioCategory: Government and/or Regulatory AuthorityN. Dolan Drger Medical Canada Inc., Richmond Hill, OntarioAssociateB. Hunt Class 1 Inc., Cambridge, OntarioCategory: Producer InterestR. Khotar Providence Health Care, Vancouver, British ColumbiaCategory: User ManagementC. Landers Weeneebayko General Hospital, Moose Factory, OntarioCategory: General InterestJ.Y. Latreille Clarion Medical Technologies Inc., Montral, QubecAssociateK.L. LeDez Memorial University of Newfoundland, St. Johns, Newfoundland and Labr

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