CAN CSA-Z10651-2-2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2 Home care ventilators for ventilator-dependent .pdf

1、 Reference numberISO 10651-2:2004(E)ISO 2004Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients Ventilateurs pulmonaires usage mdical Exigences particulires pour la scurit de base et les p

2、erformances essentielles Partie 2: Ventilateurs pour soins domicile pour patients dpendants National Standard of CanadaCAN/CSA-Z10651-2-06International Standard ISO 10651-2:2004 (second edition, 2004-07-01) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z10651-2-06, which has

3、 been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 1-55436-035-8 February 2006The 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 Na

4、tional 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, retailers, unions and professio

5、nal 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 environment. Individuals, co

6、mpanies, 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 2000 sustaining members

7、hips 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 its standards development

8、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 across Canada and inspec

9、tion 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 exchange of goods and serv

10、ices 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 of Canada is the coordina

11、ting body of the National Standards system, a federation of independent, autonomous organizations working towards the further development and improvement of voluntary standardization in the national interest. The principal objects of the Council are to foster and promote voluntary standardization as

12、 a means of advancing the national economy, benefiting the health, safety, and welfare of the public, assisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperation in the field of standards. A National Standard of Canada is a standard

13、which has been approved by the Standards Council of Canada and one which reflects a reasonable agreement among the views of a number of capable individuals whose collective interests provide to the greatest practicable extent a balance of representation of producers, users, consumers, and others wit

14、h 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. Approval of a standard as a National Standard of Canada indicates that a standard conforms to the criteria and proc

15、edures established by the Standards Council of Canada. Approval does not refer to the technical content of the standard; this remains the continuing responsibility of the accredited standards development organization. Those who have a need to apply standards are encouraged to use National Standards

16、of Canada whenever practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain the latest edition from the organization preparing the standard.The responsibility for approving National Standards of Canada rests with theStandards Council of Canada270 Albert S

17、treet, 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 suitability for th

18、eir particular purpose.Registered trade-mark of Canadian Standards AssociationStandards Update ServiceCAN/CSA-Z10651-2-06February 2006Title: Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent pati

19、entsPagination: 42 pages (CSA/1CSA/3, iviii and 31 text)To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2018370.If you require assistance, please e-mail

20、techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect your personal information.CAN/CSA-Z10651-2-06Lung ventilators for medical use Particular requirementsfor basic safety and essential performance Part 2: Homecare ventilator

21、s for ventilator-dependent patientsFebruary 2006 Canadian Standards Association CSA/1CAN/CSA-Z10651-2-06Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patientsCSA PrefaceThis is the second edi

22、tion of CAN/CSA-Z10651-2, Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Ho me care ventilators for ventilator-dependent patients, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization fo

23、r Standardization) Standard 10651-2 (second edition, 2004-07-01). It supersedes the first edition, published in 1999 as CAN/CSA-Z10651-2, Lung ventilators for medical use Part 2: Particular requirements for home care ventilators (adopted ISO 10651-2:1996).This Standard was reviewed for Canadian adop

24、tion by the CSA Subcommittee on Respiratory Technology, under the jurisdiction of the Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Comm

25、ittee. A list of the members of the Technical Committee is available upon request. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.February 2006 Canadian Standards Association 2006All rights reserved. No part of this publication may be reproduced i

26、n 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 regarding this National Standard of Canada shoul

27、d be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044www.csa.caCAN/CSA-Z10651-2-06Lung ventilators for medical use Particular requirementsfor basic safety and essential performance Part 2: Homecare ventilators for

28、 ventilator-dependent patientsCSA/2 Canadian Standards Association February 2006Canadian deviations2 Normative references Add the following These National Standards of Canada, published by the Canadian Standards Association, are adoptions of IEC and ISO Standards. The requirements of these CSA Stand

29、ards shall take precedence over the International Standards on which they are based. Any reference in CAN/CSA-Z10651-2 to the International Standard shall be replaced by a reference to the equivalent Canadian Standard. CAN/CSA-C22.2 No. 601.1-M90 (R2001)Medical electrical equipment Part 1: General r

30、equirements for safetyCAN/CSA-C22.2 No. 60601-1-2:03Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and testsCAN/CSA-ISO 14937-01Sterilization of health care products General requiremen ts for characterization of

31、a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesCAN/CSA-ISO 14971:01Medical devices Application of risk management to medical devicesCAN/CSA-Z5359-04 Low-pressure hose assemblies for use with medical gasesCAN/CSA-Z9919-94 (R2004)

32、Pulse oximeters for medical use RequirementsAdd the followingCSA (Canadian Standards Association)CAN/CSA-Z305.1-92 (R2001)Nonflammable medical gas piping systems10.101 Pneumatic driving-power suppliesReplace this clause with the followingIf the ventilator is intended to be connected to a medical gas

33、 pipeline system complying with CAN/CSA-Z305.1, it shall operate and meet the requirements of this Standard throughout a range of 280kPa to 600 kPa and shall cause no safety hazard with inlet pressures up to 1000kPa. The gas flowrate measured at the ventilators high-pressure input port shall not exc

34、eed 60 L/min (time-weighted average over 10 s) at a pressure of 280 kPa under normal conditions. Further, the transient flow requirement shall not exceed the equivalent of 200 L/min for 3 s.Note: Flowrate values are expressed under ATPD conditions.CAN/CSA-Z10651-2-06Lung ventilators for medical use

35、Particular requirementsfor basic safety and essential performance Part 2: Homecare ventilators for ventilator-dependent patientsFebruary 2006 Canadian Standards Association CSA/356.3 Connections Generalbb) High-pressure input portsReplace this Item with the followingHigh-pressure input port connecto

36、rs shall be the body of a DISS fitting complying with the requirements of CAN/CSA-Z5359, the male part of a quick connection complying with the requirements of CAN/CSA-Z5359, or a proprietary connector incompatible with the fittings and connectors specified in CAN/CSA-Z5359.Compliance is checked by

37、inspection.Reference numberISO 10651-2:2004(E)ISO 2004INTERNATIONAL STANDARD ISO10651-2Second edition2004-07-01Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients Ventilateurs pulmonaires

38、usage mdical Exigences particulires pour la scurit de base et les performances essentielles Partie 2: Ventilateurs pour soins domicile pour patients dpendants ISO 10651-2:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be

39、 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 responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts

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41、le 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 2004 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form

42、 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 4

43、7 E-mail copyrightiso.org Web www.iso.org ii ISO 2004 All rights reservedISO 10651-2:2004(E) ISO 2004 All rights reserved iiiContents Page Foreword vi Introduction vii 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements and requirements for tests 3 5 Classification

44、. 4 6 Identification, marking and documents 4 6.1 Marking on the outside of equipment or equipment parts . 4 6.3 Marking of controls and instruments 5 6.6 Identification of medical gas cylinders and connections. 5 6.8.2 Instructions for use. 6 6.8.3 Technical description . 7 6.101 Test method for le

45、gibility . 8 7 Power input 8 7.101 Pneumatic power 8 8 Basic safety categories 8 9 Removable protective means 9 10 Environmental conditions 9 10.2.1 Environment 9 10.2.2 Power supply. 9 10.101 Pneumatic driving-power supplies . 9 11 Not used. 9 12 Not used. 9 13 General. 9 14 Requirements related to

46、 classification . 10 14.2 * Class II Equipment 10 15 Limitation of voltage and/or energy 10 16 Enclosures and protective covers 10 17 Separation 10 18 Protective earthing, functional earthing and potential equalization . 10 19 Continuous leakage currents and patient auxiliary currents . 10 19.4 * Te

47、sts. 10 20 Dielectric strength. 10 21 Mechanical strength . 10 22 Moving parts 11 23 Surfaces, corners and edges. 11 24 Stability in normal use 11 25 Expelled parts 11 ISO 10651-2:2004(E) iv ISO 2004 All rights reserved26 Vibration and noise .11 27 Pneumatic and hydraulic power 11 28 Suspended masse

48、s.11 29 X-radiation11 30 Alpha, beta, gamma, neutron radiation and other particle radiation.11 31 Microwave radiation11 32 Light radiation (including lasers).11 33 Infra-red-radiation12 34 Ultraviolet radiation.12 35 Acoustical energy (including ultrasonics)12 36 Electromagnetic compatibility .12 37

49、 Locations and basic requirements12 38 Marking, accompanying documents .12 39 Common requirements for category AP and category APG equipment .12 40 Requirements and tests for category AP equipment, parts and components thereof 12 41 Requirements and tests for category APG equipment, parts and components thereof .12 42 Excessive temperatures .12 43 Fire prevention.13 43.2 * Oxygen-enriched atmospheres13