CAN CSA-Z10651-6-2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6 Home-care ventilatory support devices (First Ed.pdf

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1、 Reference numberISO 10651-6:2004(E)ISO 2004Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices Ventilateurs pulmonaires usage mdical Exigences particulires pour la scurit de base et les performances essent

2、ielles Partie 6: Dispositifs dassistance respiratoire domicile National Standard of CanadaCAN/CSA-Z10651-6-06International Standard ISO 10651-6:2004 (first edition, 2004-07-01) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z10651-6-06, which has been approved as a National S

3、tandardof Canada by the Standards Council of Canada.ISBN 1-55436-031-5 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 National Standards system in 197

4、3. 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 professional organizations, and governm

5、ental 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, companies, and associations acro

6、ss 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 memberships together form CSAs total

7、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 activities. To ensure the inte

8、grity 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 inspection and testing agencies in e

9、ight 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 services through the use of standa

10、rds, 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 coordinating body of the National Stan

11、dards 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 a means of advancing the nati

12、onal 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 which has been approved by the

13、 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 with relevant interests, as may b

14、e 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 procedures established by the Stan

15、dards 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 of Canada whenever practicable

16、. 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 Street, Suite 200Ottawa, Ontari

17、o, 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 their particular purpose.Registe

18、red trade-mark of Canadian Standards AssociationStandards Update ServiceCAN/CSA-Z10651-6-06February 2006Title: Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devicesPagination: 38 pages (CSA/1CSA/3, iviii, and

19、 27 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 2018384.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Vi

20、sit CSA Groups policy on privacy at csagroup.org/legal to find out how we protect your personal information.CAN/CSA-Z10651-6-06Lung ventilators for medical use Particular requirements forbasic safety and essential performance Part 6:Home-care ventilatory support devicesFebruary 2006 Canadian Standar

21、ds Association CSA/1CAN/CSA-Z10651-6-06Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devicesCSA PrefaceThis is the first edition of CAN/CSA-Z10651-6, Lung ventilators for medical use Particular requirements f

22、or basic safety and essential performance Part 6: Home-care ventilatory support devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 10651-6 (first edition, 2004-07-01).This Standard was reviewed for Canadian

23、 adoption by the CSA Subcommittee on Respiratory Technology, under the 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

24、 Technical Committee. 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

25、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 regarding this National Standard

26、of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044www.csa.caCAN/CSA-Z10651-6-06Lung ventilators for medical use Particular requirements for basicsafety and essential performance Part 6:Home-care

27、ventilatory support devicesCSA/2 Canadian Standards Association February 2006Canadian deviations2 Normative referencesAdd the followingThese National Standards of Canada, published by the Canadian Standards Association, are adoptions of IEC and ISO Standards. The requirements of these CSA Standards

28、shall take precedence over the International Standards on which they are based. Any reference in CAN/CSA-Z10651-6 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 require

29、ments 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 requirements for characterization of a steri

30、lizing agent and the development, validation and routine control of a sterilization process for medical devicesCAN/CSA-Z5359-04Low-pressure hose assemblies for use with medical gasesCAN/CSA-Z9919-94 (R2004)Pulse oximeters for medical use RequirementsAdd the followingCSA (Canadian Standards Associati

31、on)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 pipeline system complying with CAN/CSA-Z305.1, it shall operate and meet the requirements of

32、this Standard throughout a pressure range of 280 kPa to 600 kPa, and shall cause no safety hazard with inlet pressures up to 1000 kPa. The gas flowrate measured at the ventilators high-pressure input port shall not exceed 60 L/min (time-weighted average over 10 s) at a pressure of 280 kPa under norm

33、al condition. 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-Z10651-6-06Lung ventilators for medical use Particular requirements forbasic safety and essential performance Part 6:Home-care

34、ventilatory support devicesFebruary 2006 Canadian Standards Association CSA/356.3 Connections Generalbb) High-pressure input portsReplace this Item with the followingHigh-pressure input port connectors shall be the body of a DISS fitting complying with the requirements of CAN/CSA-Z5359, the male par

35、t 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 inspection.Reference numberISO 10651-6:2004(E)ISO 2004INTERNATIONAL STANDARD ISO10651-6First edition2

36、004-07-01Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices Ventilateurs pulmonaires usage mdical Exigences particulires pour la scurit de base et les performances essentielles Partie 6: Dispositifs dassis

37、tance respiratoire domicile ISO 10651-6:2004(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 the computer pe

38、rforming 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 used to create this

39、 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 Centra

40、l 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 or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at

41、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-mail copyrightiso.org Web www.iso.org ii ISO 2004 All rights reservedISO 10651-6:2004(E) ISO 2004 All rights reserved iiiConten

42、ts Page Foreword vi Introduction vii 1 Scope 1 2 Normative references 1 3 Terms and definitions . 2 4 General requirements and general requirements for tests. 3 5 Classification . 3 6 Identification, marking and documents. 3 6.1 Marking on the outside of equipment or equipment parts 4 6.3 Marking of

43、 controls and instruments 5 6.6 Identification of medical gas cylinders and connections 5 6.101 Test method for legibility 7 7 Power input 8 7.101 Pneumatic power. 8 8 Basic safety categories. 8 9 Removable protective means. 8 10 Environmental conditions. 8 10.101 Pneumatic driving power supplies 9

44、11 Not used . 9 12 Not used . 9 13 General 9 14 Requirements related to classification9 14.2 * Class II Equipment. 9 15 Limitation of voltage and/or energy. 9 16 Enclosures and protective covers . 9 17 Separation 9 18 Protective earthing, functional earthing and potential equalization 9 19 Continuou

45、s leakage currents and patient auxiliary currents 10 19.4 * Tests 10 20 Dielectric strength . 10 21 Mechanical strength 10 22 Moving parts 10 23 Surfaces, corners and edges . 10 24 Stability in normal use 10 25 Expelled parts 10 ISO 10651-6:2004(E) iv ISO 2004 All rights reserved26 Vibration and noi

46、se10 27 Pneumatic and hydraulic power.10 28 Suspended masses .11 29 X-radiation 11 30 Alpha, beta, gamma, neutron radiation and other particle radiation11 31 Microwave radiation 11 32 Light radiation (including lasers) .11 33 Infra-red-radiation 11 34 Ultra-violet radiation 11 35 Acoustical energy (

47、including ultrasonics) 11 36 Electromagnetic compatibility11 37 Locations and basic requirements.11 38 Marking, accompanying documents12 39 Common requirements for category AP and category APG equipment12 40 Requirements and tests for category AP equipment, parts and components thereof.12 41 Require

48、ments and tests for category APG equipment, parts and components thereof12 42 Excessive temperatures12 43 Fire prevention .12 43.2 Oxygen enriched atmospheres 12 43.101 Compatibility with pressurized oxygen .13 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, di

49、sinfection and compatibility 13 44.3 Spillage .13 44.7 Cleaning, sterilization and disinfection .13 44.8 Compatibility with substances used with the equipment13 45 Pressure vessels and parts subject to pressure13 46 Human errors14 47 Electrostatic charges.14 48 Biocompatibility .14 49 Interruption of the power supply14 49.101 * Internal electrical power source.14 49.102 Spontaneous brea