1、 Reference numberISO 8835-4:2004(E)ISO 2004Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices Systmes danesthsie par inhalation Partie 4: Dispositifs dalimentation en vapeur anesthsique National Standard of CanadaCAN/CSA-Z8835-4-06International Standard ISO 8835-4:2004 (fir
2、st edition, 2004-06-01) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z8835-4-06, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 1-55436-033-1 March 2006The Canadian Standards Association (CSA), under whose auspices this Natio
3、nal 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 standards development and certification activities. CSA standards reflec
4、t 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 by municipal, provincial, and federal governments in their regulatio
5、ns, 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 and skills to CSA Committee work and supporting the Associations o
6、bjectives 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 source of income for CSAs standards development activities. The Asso
7、ciation 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 inspects products that bear the CSA Mark. In addition to its head of
8、fice 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 its corporate mission: CSA is an independent service organization w
9、hose 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 further information on CSA services, write toCanadian Standards Associat
10、ion5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards Council of Canada is the coordinating body of the National Standards system, a federation of independent, autonomous organizations working towards the further development and improvement of voluntary standardization in t
11、he national interest. The principal objects of the Council are to foster and promote voluntary standardization as 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,
12、 and furthering international cooperation in the field of standards. A National Standard of Canada is a standard 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 prov
13、ide to the greatest practicable extent a balance of representation of producers, users, 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. Ap
14、proval of a standard as a National Standard of Canada indicates that a standard conforms to the criteria and procedures 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 stand
15、ards development organization. Those who have a need to apply standards are encouraged to use National Standards 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.Th
16、e responsibility for approving National Standards of Canada rests with theStandards Council of Canada270 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
17、its Scope, it is importantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationNameOrganizationAddressCityProvince/StateCountry Postal/Zip CodeE-mailI consent to CSA collecting and using t
18、he above information to send me updates relating to this publication.Visit CSAs policy on privacy at www.csagroup.org/legal to find out how we protect your personal information.CAN/CSA-Z8835-4-06CSA Standards Update ServiceCAN/CSA-Z8835-4-06March 2006Title: Inhalational anaesthesia systems Part 4: A
19、naesthetic vapour delivery devicesPagination: 26 pages (CSA/1CSA/2, ivi, and 18 text)Automatic notifications about any updates 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
20、 My Account on the navigation bar.The List ID for this document is 2018382.To receive printed updates, please complete and return the attached card.AffranchirsuffisammentPlaceStamp HereASSOCIATION CANADIENNE DENORMALISATIONBUREAU CENTRAL DE LINFORMATION5060, SPECTRUM WAY, BUREAU 100MISSISSAUGA ON L4
21、W 5N6CANADACANADIAN STANDARDSASSOCIATIONCONSOLIDATED MAILING LIST5060 SPECTRUM WAY, SUITE 100MISSISSAUGA ON L4W 5N6CANADACAN/CSA-Z8835-4-06Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devicesMarch 2006 Canadian Standards Association CSA/1CAN/CSA-Z8835-4-06Inhalational anaesth
22、esia systems Part 4: Anaesthetic vapour delivery devicesCSA PrefaceThis is the first edition of CAN/CSA-Z8835-4, Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for
23、 Standardization) Standard 8835-4 (first edition, 2004-06-01). This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Anaesthetic Equipment, under the jurisdiction of the Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the St
24、rategic Steering Committee on Health Care Technology, and has been formally approved by the 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. March 2006
25、 Canadian Standards Association 2006All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text, they should be int
26、erpreted 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, Canada L4W 5N61-800-463-6727 416-747-4044www.csa.caCAN/CSA-Z8835-4-06Inhalational anaesthesia sy
27、stems Part 4: Anaesthetic vapour delivery devicesCSA/2 Canadian Standards Association March 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
28、 these CSA Standards shall take precedence over the International Standards on which they are based. Any reference in CAN/CSA-Z8835-4 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 P
29、art 1: General requirements for safetyCAN/CSA-C22.2 No. 60601-1-2:03 Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and testsCAN/CSA-C22.2 No. 60601-2-13:02Medical electrical equipment Part 2-13: Particular requi
30、rements for the safety of anaesthetic workstationsCAN/CSA-E60079-11:02Electrical apparatus for explosive gas atmospheres Part 11: Intrinsic safety “i”CAN/CSA-ISO 11196-98 (R2003)Anaesthetic gas monitorsCAN/CSA-Z5360-94 (R2004) Anaesthetic vaporizers Agent-specific filling systemsCAN/CSA-Z8835-3-00In
31、halation anaesthesia systems Part 3: Anaesthetic gas scavenging systems Transfer and receiving systems 6.101 Test method for legibilityReplace this clause with the followingLegible indications shall be correctly perceived by an operator with a visual acuity of 0 on the log MAR scale or 6-6 (20/20) v
32、ision (corrected if necessary) from a distance of 1 m 10% at a light level of 215 lx 65 lx, when viewing the information, markings, etc. perpendicular to and including 15 above, below, left, and right of the normal line of sight of the operator.Reference numberISO 8835-4:2004(E)ISO 2004INTERNATIONAL
33、 STANDARD ISO8835-4First edition2004-06-01Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices Systmes danesthsie par inhalation Partie 4: Dispositifs dalimentation en vapeur anesthsique ISO 8835-4:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accord
34、ance 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 performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes lic
35、ensing 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 PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printi
36、ng. 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 2004 All rights reserved. Unless otherwise specified, no part of this pu
37、blication 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 Ge
38、neva 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 8835-4:2004(E) ISO 2004 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 General require
39、ments and general requirements for tests 2 5 Classification. 2 6 Identification, marking and documents 2 7 Power input 4 8 Basic safety categories 4 9 Removable protective means 4 10 Environmental conditions 4 11 Not used. 4 12 Not used. 4 13 General. 4 14 Requirements related to classification . 4
40、15 Limitation of voltage and/or energy 5 16 Enclosures and protective covers 5 17 Separation 5 18 Protective earthing, functional earthing and potential equalization . 5 19 Continuous leakage currents and patient auxiliary currents . 5 20 Dielectric strength. 5 21 Mechanical strength . 5 22 Moving p
41、arts 5 23 Surfaces, corners and edges. 5 24 Stability in normal use 5 25 Expelled parts 5 26 Vibration and noise. 6 27 Pneumatic and hydraulic power 6 28 Suspended masses. 6 29 X-radiation 6 30 Alpha, beta, gamma, neutron radiation and other particle radiation. 6 31 Microwave radiation 6 32 Light ra
42、diation (including lasers) 6 33 Infra-red radiation . 6 ISO 8835-4:2004(E) iv ISO 2004 All rights reserved34 Ultraviolet radiation.6 35 Acoustical energy (including ultrasonics)6 36 Electromagnetic compatibility .6 37 Locations and basic requirements7 38 Marking and accompanying documents.7 39 Commo
43、n requirements for category AP and category APG equipment .7 40 Requirements and tests for category AP equipment, parts and components thereof 7 41 Requirements and tests for category APG equipment, parts and components thereof .7 42 Excessive temperatures .7 43 Fire prevention.7 44 Overflow, spilla
44、ge, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility8 45 Pressure vessels and parts subject to pressure .8 46 Human errors .8 47 Electrostatic charges 8 48 Biocompatibility.8 49 Interruption of the power supply .8 50 Accuracy of operating data 9 51 Prote
45、ction against hazardous output9 52 Abnormal operation and fault conditions.10 53 Environmental tests 11 54 General .11 55 Enclosures and covers .11 56 Components and general assembly11 57 Mains parts, components and layout11 58 Protective earthing Terminals and connections .11 59 Construction and la
46、yout .11 101 Additional requirements for AVDDs11 102 Appendices of IEC 60601-1:1988 .12 Annex AA (informative) Rationale .13 Annex BB (informative) Recommended colours for colour coding of anaesthetic vapour delivery devices .16 Annex CC (normative) Test for flammability of anaesthetic agents17 Bibl
47、iography18 ISO 8835-4:2004(E) ISO 2004 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical commit
48、tees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the In
49、ternational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies castin
