1、 Reference numberISO 22870:2006(E)ISO 2006INTERNATIONAL STANDARD ISO22870First edition2006-02-01Point-of-care testing (POCT) Requirements for quality and competenceAnalyses de biologie dlocalises (ADBD) Exigences concernant la qualit et la comptence National Standard of CanadaCAN/CSA-Z22870-07Intern
2、ational Standard ISO 22870:2006 (first edition, 2006-02-01) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z22870-07, which has been approved as a National Standard ofCanada by the Standards Council of Canada.ISBN 978-1-55436-539-5 November 2007Legal Notice for StandardsCanad
3、ian 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 interests to achieve consensus and develop a standard. Although CSA admini
4、sters 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, or conditions of any kind, express
5、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 does not warrant the accuracy, completeness, or currency o
6、f 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, SUBSIDIARIES, OR AFFILIATED COMPANIES, OR THEIR EMPLOYEES, DIRECTORS,
7、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, OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS, WHETHER BASE
8、D 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, INJURY, LOSS, COSTS, OR EXPENSES.In publishing and making this document ava
9、ilable, 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 directed to those who have the appropriate degree of experience to use
10、 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 voluntary standards and related documents. CSA has no power, nor does it
11、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 form), CSA is the owner, or the authorized licensee, of all works conta
12、ined 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 inventions and trade secrets are protected by patents and applications for patents. Without limit
13、ation, 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 such use, modification, copying, or disclosure. To the extent permitte
14、d 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 not be held responsible for identifying any or all such patent rights. U
15、sers 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 and non-commercial use only. The user of this document is authorized t
16、o 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 print or paper form may be distributed only to persons who are authori
17、zed 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;.sell this document without authorization from CSA; or.make an electro
18、nic 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, you are required to destroy them immediately. Use of this document const
19、itutes your acceptance of the terms and conditions of this Legal Notice.NameOrganizationAddressCityProvince/StateCountry Postal/Zip CodeE-mailI consent to CSA collecting and using the above information to send me updates relating to this publication.Visit CSAs policy on privacy at www.csagroup.org/l
20、egal to find out how we protect your personal information.CAN/CSA-Z22870-07CSA Standards Update ServiceCAN/CSA-Z22870-07November 2007Title: Point-of-care testing (POCT) Requirements for quality and competencePagination: 20 pages (CSA/1CSA/4, iv, and 11 text)Automatic notifications about any updates
21、to this publication are available.To register for e-mail notifications, and/or to download any existing updates in PDF, enter the Online Store at www.ShopCSA.ca and click on My Account on the navigation bar.The List ID for this document is 2019961.To receive printed updates, please complete and retu
22、rn the attached card.AffranchirsuffisammentPlaceStamp HereASSOCIATION CANADIENNE DENORMALISATIONBUREAU CENTRAL DE LINFORMATION5060, SPECTRUM WAY, BUREAU 100MISSISSAUGA ON L4W 5N6CANADACANADIAN STANDARDSASSOCIATIONCONSOLIDATED MAILING LIST5060 SPECTRUM WAY, SUITE 100MISSISSAUGA ON L4W 5N6CANADAThe Ca
23、nadian 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, voluntary membership association engaged in stand
24、ards 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 industry and commerce and often adopted b
25、y 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 standards development by volunteering their time
26、 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. Sustaining memberships represent a major s
27、ource 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 Association regularly and continually audits and i
28、nspects 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 developed the necessary expertise to meet
29、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 national and international needs.For furth
30、er 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, autonomousorganizations working towards the
31、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 of the public, assistingand protecting th
32、e 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 approved by the SCC according to the require
33、ments 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 practicable extent, a balance of representatio
34、n 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 national interest.Those who have a need to a
35、pply 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 Canada rests with theStandards Council of Can
36、ada270 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 responsibility of the users to judge its sui
37、tability for their particular purpose.Registered trade-mark of Canadian Standards AssociationApproved byStandards Council of CanadaNational Standard of CanadaPublished in November 2007 by Canadian Standards AssociationA not-for-profit private sector organization5060 Spectrum Way, Suite 100, Mississa
38、uga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044Visit our Online Store at www.ShopCSA.caCAN/CSA-Z22870-07Point-of-care testing (POCT) Requirements for quality and competencePrepared by International Organization for StandardizationReviewed byCAN/CSA-Z22870-07 Point-of-care testing (POCT) Requ
39、irements for quality and competenceNovember 2007 Canadian Standards Association CSA/3CAN/CSA-Z22870-07Point-of-care testing (POCT) Requirements for quality and competenceCSA PrefaceThis is the first edition of CAN/CSA-Z22870, Point-of-care testing (POCT) Requirements for quality and competence, whic
40、h is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 22870 (first edition, 2006-02-01). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Medical Laboratory Quality Systems, under the juri
41、sdiction of 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.November 2007 Canadian Standards Association 2007All rights reserved.
42、 No part 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
43、regarding 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
44、toll-free 1-800-463-6727 or 416-747-4044.CAN/CSA-Z22870-07 Point-of-care testing (POCT) Requirements for quality and competenceCSA/4 Canadian Standards Association November 2007Canadian deviations2 Normative references Add the following The following National Standard of Canada, published by the Can
45、adian Standards Association, is an adoption of an ISO Standard. The requirements of the CSA Standard shall take precedence over the International Standard on which it is based; any reference in CAN/CSA-Z22870 to the International Standard shall be replaced by a reference to the equivalent Canadian S
46、tandard. CAN/CSA-Z15189-03Medical laboratories Particular requirements for quality and competenceReference numberISO 22870:2006(E)ISO 2006INTERNATIONAL STANDARD ISO22870First edition2006-02-01Point-of-care testing (POCT) Requirements for quality and competenceAnalyses de biologie dlocalises (ADBD) E
47、xigences concernant la qualit et la comptence ISO 22870:2006(E) PDF disclaimer This PDF file may 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
48、 the computer performing the editing. In downloading this file, parties accept therein the responsibility 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 use
49、d 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 the address given below. ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, incl
