1、Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentratorsCAN/CSA-ISO 8637:12(ISO 8637:2010, IDT)National Standard of CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Legal Notice for StandardsCanadian Standards Association (CSA) st
2、andards 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 administers the process and establishes
3、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 or implied, including, without lim
4、itation, 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 of any of the information published
5、 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, OR OFFICERS, BE LIABLE FOR ANY DIR
6、ECT, 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 BASED IN CONTRACT, TORT (INCLUDING NEG
7、LIGENCE), 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 available, CSA is not undertaking to
8、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 and apply its contents, and CSA a
9、ccepts 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 undertake, to enforce compliance w
10、ith 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 contained herein that are protected by
11、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 limitation, the unauthorized use, modif
12、ication, 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 permitted by licence or by law, CSA reserv
13、es 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. Users of this standard are expressl
14、y 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 to do only the following:If this do
15、cument 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 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
16、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 electronic copy of
17、 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 constitutes your
18、 acceptance of the terms and conditions of this Legal Notice.CSA Standards Update ServiceCAN/CSA-ISO 8637:12March 2012Title:Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentratorsPagination:27 pages (CSA/1CSA/4, iv, and 18 text)To regis
19、ter for e-mail notification about any updates to this publicationgo on-line to shop.csa.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 2421760.If you require assistance, please e-mail techs
20、upportcsa.ca or call 416-747-2233.Visit CSAs 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 Cou
21、ncil 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 standards reflect a national consensus of producers and users including manufacturers, consumers, retaile
22、rs, 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, safety, building and construction, and the envi
23、ronment. Individuals, companies, 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
24、 2000 sustaining memberships 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 it
25、s standards development 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
26、across Canada and inspection 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 ex
27、change of goods and services 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 o
28、f Canada (SCC) is thecoordinating 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
29、standardization as a meansof 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 (N
30、SC) is a standardprepared 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
31、 consensus of a number 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
32、. 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 apply standards areencouraged to use NSCs. These standards are subjectto periodic review. Users of NSCs are cautionedto obtain the latest edition from the SD
33、O which publishes the standard.The responsibility for approving standards as National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaAlthough the intended primary application of this Standard is stated in its Scope, it is import
34、antto note that it remains the responsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationCette norme est offerte en anglais seulement pour le moment. La CSA publiera la version enfranais ds quelle sera produite par lorgan
35、isme rdacteur.Reviewed byNational Standard of CanadaPublished in March 2012 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 shop.csa.caPrepared byIntern
36、ational Organization for StandardizationApproved byStandards Council of CanadaCAN/CSA-ISO 8637:12Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentratorsCAN/CSA-ISO 8637:12Cardiovascular implants and extracorporealsystems Haemodialyser s
37、, haemodiafilters,haemofilters and haemoconcentratorsCSA/4 Canadian Standards Association March 2012CAN/CSA-ISO 8637:12Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentratorsCSA PrefaceThis is the first edition of CAN/CSA-ISO 8637, Card
38、iovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which is an adoption, without modification, of the identically titled ISO (International Organization for Standardization) Standard 8637 (third edition, 2010-07-01). It replaces the p
39、revious edition published in 2008 as CAN/CSA-Z8637, Cardiovascular implants and artificial organs Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (adopted ISO 8637:2004). At the time of publication, ISO 8637:2010 is available from ISO in English only. CSA will publish the French
40、 version when it becomes available.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Kidney Dialysis, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard ha
41、s been approved as a National Standard of Canada by the Standards Council of Canada.March 2012 Canadian Standards Association 2012All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of thepublisher. ISO material is reprinted with per
42、mission. 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, Ontario, Can
43、ada 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 to the ap
44、propriate 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 proposed change;
45、 and(d) rationale for the change.Reference numberISO 8637:2010(E)ISO 2010INTERNATIONAL STANDARD ISO8637Third edition2010-07-01Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Implants cardiovasculaires et systmes extracorporels H
46、modialyseurs, hmodiafiltres, hmofiltres et hmoconcentrateurs ISO 8637:2010(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 an
47、d installed on 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 softwar
48、e 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 f
49、ound, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2010 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, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-
