1、 ISO 2013. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited.CAN/CSA-ISO 81060-2:14(ISO 81060-2:2013, IDT)National Standard of CanadaCAN/CSA-ISO 81060-2:14Non-invasive sphygmomanometers Part 2: Clinicalinvestigation of automated measurementtype(ISO 81060-2:2013, I
2、DT)LegalNotice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards development process approvedby the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve conse
3、nsusand develop a standard. Although CSA Group administers the process and establishes rules to promote fairness in achieving consensus,it doesnot independently test, evaluate, or verify the content of standards.Disclaimerand exclusion of liabilityThis document is provided without any representation
4、s, warranties, or conditions of any kind, express or implied, including, without limitation,implied warranties or conditions concerning this documents fitness for a particularpurpose or use, its merchantability, or its non-infringementof any third partys intellectual property rights. CSA Group does
5、not warrant the accuracy, completeness, or currency of any of the informationpublished in this document. CSA Group makes no representations or warranties regarding this documents compliancewith any applicablestatute, rule, or regulation.IN NO EVENT SHALL CSA GROUP, ITS VOLUNTEERS, MEMBERS, SUBSIDIAR
6、IES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS, OROFFICERS, 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 DAT
7、A,OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS,WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR ANY OTHER THEORY OFLIABILITY, ARISING OUT OF OR RESULTING FROM ACCESS TO OR POSSESSION OR USE OF THIS DOCUMENT, EVEN IF CSA GROUP HAS BEENADVISED 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 servicesfor or on behalf of anyperson or entity or to perform any duty owed by any person or entity to another person or entity. The information in this document is directe
9、dto those who have the appropriate degree of experience to use and apply its contents, and CSA Group accepts no responsibility whatsoeverarising 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 publishes v
10、oluntary standards and related documents. CSA Group has no power, nor does itundertake, to enforce compliancewith the contents of the standards or other documents it publishes.Intellectualpropertyrights and ownershipAs between CSA Group and the users of this document (whether it be in printed or ele
11、ctronic form), CSA Group is the owner, or the authorizedlicensee,of all works contained herein that are protected by copyright, all trade-marks (except as otherwisenoted to the contrary), and allinventions and trade secrets that may be contained in this document, whether or not such inventions and t
12、rade secrets are protected by patentsand applications for patents. Without limitation, the unauthorized use, modification, copying, or disclosure of this document may violate lawsthat protect CSA Groups and/or others intellectual property and may give rise to a right in CSA Group and/or others to se
13、ek legal redress forsuch use, modification, copying, or disclosure. To the extent permitted by licence or by law, CSA Group reserves all intellectual property rights inthis document.Patent rightsAttention is drawn to the possibility that some of the elements of this standard may be the subject of pa
14、tent rights. CSA Group shall not be heldresponsible for identifying any or all such patent rights. Users of this standard are expressly advised that determination of the validity of any suchpatent rights is entirely their own responsibility.Authorizeduse of this documentThis document is being provid
15、ed by CSA Group for informational and non-commercial use only. The user of this document is authorized to doonly 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 if
16、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 this document in any
17、 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 document or make any
18、copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of this document constitutesyour acceptanceof the terms and conditions of this Legal Notice.Standards UpdateServiceCAN/CSA-ISO 81060-2:14October 2014Title: Non-invasive sphygmomanometers
19、Part 2: Clinical investigation of automatedmeasurement typeTo 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 2423514.If you require assistance, please e-
20、mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legalto find out how we protect your personalinformation.CanadianStandards Association (operating as “CSA Group”), underwhose auspicesthis National Standard has been produced, waschartered in 1919 an
21、d accredited by the Standards Council of Canadato the National Standards system in 1973. It is a not-for-profit,nonstatutory, voluntary membership association engaged instandards development and certification activities.CSA Group standards reflect a national consensus of producers andusers including
22、 manufacturers, consumers, retailers, unions andprofessional organizations, and governmental agencies. Thestandards are used widely by industry and commerce and oftenadopted by municipal, provincial, and federal governments in theirregulations, particularlyin the fields of health, safety, building a
23、ndconstruction, and the environment.Individuals, companies, and associationsacross Canada indicate theirsupport for CSA Groups standards development by volunteeringtheir time and skills to Committee work and supporting CSA Groupsobjectivesthrough sustaining memberships. The more than 7000committee v
24、olunteers and the 2000 sustaining membershipstogether form CSA Groups total membership from which itsDirectors are chosen. Sustaining memberships represent a majorsource of income for CSA Groups standards development activities.CSA Group offers certification and testing servicesin support of andas a
25、n extension to its standards development activities. To ensurethe integrity of its certification process, CSA Group regularly andcontinually audits and inspects products that bear theCSA Group Mark.In addition to its head office and laboratory complex in Toronto, CSAGroup has regional branch offices
26、 in major centres across Canadaand inspection and testing agencies in eight countries. Since 1919,CSA Group has developed the necessaryexpertise to meet itscorporate mission: CSA Group is an independent service organizationwhose mission is to provide an open and effective forum foractivities facilit
27、ating the exchange of goods and servicesthrough theuse of standards, certification and related servicesto meet nationaland international needs.For further information on CSA Group services,write toCSA Group5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Councilof Canada
28、(SCC) is the coordinating body ofthe Canadian standardization network, which is composed of peopleand organizations involved in the development,promotion andimplementation of standards. Through the collaborative efforts ofCanadian standardization network members, standardization ishelping to advance
29、 the social and economic well-being of Canada andto safeguard the health and safety of Canadians.The networksefforts are overseen by SCC.The principal objectives of SCC are to foster and promote voluntarystandardization as a means of advancing the national economy,supporting sustainable development,
30、benefiting the health, safetyand welfare of workers and the public, assisting and protecting theconsumer, facilitating domestic and international trade, andfurthering international cooperation in relation to standardization.An important facet of the Canadian standards development system isthe use of
31、 the following principles: consensus;equal access andeffective participation by concerned interests; respect for diverseinterests and identification of those who should be afforded accessto provide the needed balance of interests; mechanismfor disputeresolution; opennessand transparency;open access
32、by interestedparties to the procedures guiding the standards developmentprocess; clarity with respect to the processes; and Canadian interestconsideration as the initial basis for the development of standards.A National Standard of Canada (NSC) is a standard prepared orreviewed by an SCC-accredited
33、SDO and approved by the SCCaccording to NSC approval requirements. Approval does not refer tothe technical content of the standard, as this remains theresponsibility of the SDO. An NSC reflects a consensus of a number ofcapable individuals whose collective interests provide, to the greatestpracticab
34、le extent, a balance of representation of general interests,producers, regulators, users (including consumers) and others withrelevant interests, as may be appropriate to the subject at hand.NSCs are intended to make a significant and timely contribution tothe Canadian interest.Those who have a need
35、 to apply standards are encouraged to useNSCs. These standards are subjectto periodic review. Users of NSCsare cautioned to obtain the latest edition from the SDO thatpublishes the standard.The responsibility for approving standards as NSCs rests withStandards Council of Canada270 Albert Street, Sui
36、te 200Ottawa, Ontario, K1P 6N7CanadaCette Norme Nationale du Canada est disponible en versions franaise et anglaise.Although the intended primaryapplication of this Standard is stated in its Scope, it is important to note that it remainsthe responsibility of theusers to judge its suitability for the
37、ir particular purpose.TMA trade-mark of the Canadian Standards Association,operating as “CSA Group”ICS 11.040.10ISBN 978-1-77139-853-4 2014 CSA GroupAll rights reserved.No part of this publication may be reproduced in any form whatsoever withoutthe prior permission of the publisher.Published in Octo
38、ber 2014 by CSA GroupA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N6To purchase standards and related publications, visit our Online Store at shop.csa.caor call toll-free 1-800-463-6727 or 416-747-4044.TMA trade-mar k of the Canadian S t
39、andards Association,operating as “CSA Group”Reviewed byPrepared byInternational Organization for StandardizationApproved byNon-invasive sphygmomanometers Part 2:Clinical investigation of automatedmeasurementtype(ISO 81060-2:2013,IDT)CAN/CSA-ISO 81060-2:14National Standard of CanadaCAN/CSA-ISO 81060-
40、2:14Non-invasive sphygmomanometers Part 2: Clinicalinvestigation of automated measurementtypeOctober 2014 2014 CSA GroupCSA/5CAN/CSA-ISO 81060-2:14Non-invasive sphygmomanometers Part 2: Clinical investigation of automatedmeasurementtype(ISO 81060-2:2013,IDT)CSA PrefaceThis is the first edition of CA
41、N/CSA-ISO 81060-2, Non-invasive sphygmomanometers Part 2: Clinicalinvestigation of automated measurementtype, which is an adoption without modification of theidentically titled ISO (International Organization for Standardization) Standard 81060-2 (second edition,2013-05-01).For brevity, this Standar
42、d will be referred to as “CAN/CSA-ISO 81060-2” throughout.This Standard was reviewed for Canadian adoption by the Standards Mirror Committee to ISO/TC 121,under the jurisdiction of the CSA Technical Committee on Perioperative Safety and the CSA StrategicSteering Committee on Health Care Technology a
43、nd Systems, and has been formally approved by theTechnical Committee. This Standard has been approved as a National Standard of Canada by theStandards Council of Canada. 2014 CSA GroupAll rights reserved.No part of this publication may be reproducedin any form whatsoeverwithout theprior permission o
44、f the publisher. ISO material is reprinted with permission. Where the words “thisInternational Standard” appear in the text, they should be interpreted as “this National Standard ofCanada”.Inquiries regarding this National Standard of Canada should be addressedtoCSA Group5060 Spectrum Way, Suite 100
45、, Mississauga, Ontario, Canada, L4W 5N61-800-463-6727 416-747-4000http:/csa.caTo purchase standards and related publications, visit our Online Store at shop.csa.caor call toll-free1-800-463-6727or 416-747-4044.This Standard is subject to review five years from the date of publication, and suggestion
46、s for its improvement willbe referred to the appropriate committee. To submit a proposal for change, please send the following informationto inquiriescsagroup.org and include “Proposal for change” in the subject line:a) Standard designation (number);b) relevant clause,table, and/or figure number;c)
47、wording of the proposed change; andd) rationale for the change.CSA Technical Committeeon PerioperativeSafetyR. Khotar Providence Health Care,Vancouver, British ColumbiaCategory: User ManagementChairB.W. McLeod Maple Ridge, British ColumbiaCategory: Health Care ProfessionalVice-ChairM. Armutlu Jewish
48、 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.Y. Deslauriers Consultant,Gatineau, QubecCategory: Gove
49、rnmentand/or Regulatory AuthorityN. Dolan Drger Medical Canada Inc.,Mississauga, OntarioCategory: Producer InterestB. Hunt Class 1 Inc.,Cambridge, OntarioCategory: Producer InterestC. 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 LabradorCategory: Health Care ProfessionalG. Mendes GE Healthcare Technologies,Mississauga, OntarioCategory: Producer InterestP.I. Me
