CAN CSA-Z10079-2003 Medical suction equipment - Part 1 Electrically powered suction equipment - Safety requirements (First Edition).pdf

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1、AReference numberISO 10079-1:1999(E)Medical suction equipment Part 1:Electrically powered suction equipment Safety requirementsAppareils daspiration mdicale Partie 1: Appareils lectriques daspiration Prescriptions de scuritNational Standard of CanadaCAN/CSA-Z10079-1-03International Standard ISO 1007

2、9-1:1999 (second edition, 1999-08-15) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z10079-1-03, which has been approved as a National Standard ofCanada by the Standards Council of Canada.ISBN 1-55397-181-7 May 2003The Canadian Standards Association (CSA), The Standards Coun

3、cil of Canada is theunder whose auspices this National Standard has been coordinating body of the National Standards system, produced, was chartered in 1919 and accredited by a federation of independent, autonomousthe Standards Council of Canada to the National organizations working towards the furt

4、herStandards system in 1973. It is a not-for-profit, development and improvement of voluntarynonstatutory, voluntary membership association standardization in the national interest.engaged in standards development and certification The principal objects of the Council are to foster activities. and p

5、romote voluntary standardization as a means CSA standards reflect a national consensus of of advancing the national economy, benefiting theproducers and users including manufacturers, health, safety, and welfare of the public, assisting consumers, retailers, unions and professional and protecting th

6、e consumer, facilitating domestic organizations, and governmental agencies. The and international trade, and furthering internationalstandards are used widely by industry and commerce cooperation in the field of standards.and often adopted by municipal, provincial, and A National Standard of Canada

7、is a standard whichfederal governments in their regulations, particularly in has been approved by the Standards Council ofthe fields of health, safety, building and construction, Canada and one which reflects a reasonableand the environment. agreement among the views of a number of capableIndividual

8、s, companies, and associations across individuals whose collective interests provide to theCanada indicate their support for CSAs standards greatest practicable extent a balance ofdevelopment by volunteering their time and skills to representation of producers, users, consumers, andCSA Committee wor

9、k and supporting the Associations others with relevant interests, as may be appropriateobjectives through sustaining memberships. The more to the subject in hand. It normally is a standardthan 7000 committee volunteers and the 2000 which is capable of making a significant and timelysustaining member

10、ships together form CSAs total contribution to the national interest.membership from which its Directors are chosen. Approval of a standard as a National Standard ofSustaining memberships represent a major source of Canada indicates that a standard conforms to theincome for CSAs standards developmen

11、t activities. criteria and procedures established by the StandardsThe Association offers certification and testing Council of Canada. Approval does not refer to theservices in support of and as an extension to its technical content of the standard; this remains thestandards development activities. T

12、o ensure the continuing responsibility of the accreditedintegrity of its certification process, the Association standards-development organization.regularly and continually audits and inspects products Those who have a need to apply standards arethat bear the CSA Mark. encouraged to use National Sta

13、ndards of CanadaIn addition to its head office and laboratory complex whenever practicable. These standards are subject in Toronto, CSA has regional branch offices in major to periodic review; therefore, users are cautioned centres across Canada and inspection and testing to obtain the latest editio

14、n from the organizationagencies in eight countries. Since 1919, the preparing the standard.Association has developed the necessary expertise to The responsibility for approving National Standards meet its corporate mission: CSA is an independent of Canada rests with theservice organization whose mis

15、sion is to provide an Standards Council of Canadaopen and effective forum for activities facilitating the 270 Albert Street, Suite 200exchange of goods and services through the use of Ottawa, Ontario, K1P 6N7standards, certification and related services to meet Canadanational and international needs

16、.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaCette 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

17、 importantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.Registered trade-mark of Canadian Standards AssociationStandards Update ServiceCAN/CSA-Z10079-1-03May 2003Title: Medical suction equipment Part 1: Electrically powered suction equi

18、pment Safety requirementsPagination: 33 pages (CSA/1 and CSA/2, iiii, and 28 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 2014918.If you require

19、assistance, please e-mail 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.Medical suction equipment Part 1: ElectricallyCAN/CSA-Z10079-1-03 powered suction equipment Safety requirementsMay 2003

20、 Canadian Standards Association CSA/1CAN/CSA-Z10079-1-03Medical suction equipment Part 1: Electrically powered suctionequipment Safety requirementsCSA PrefaceThis is the first edition of CAN/CSA-Z10079-1, Medical suction equipment Part 1: Electrically poweredsuction equipment Safety requirements, wh

21、ich is an adoption, with Canadian deviations, of theidentically titled ISO (International Organization for Standardization) Standard 10079-1 (second edition,1999-08-15).This Standard was reviewed for Canadian adoption by the CSA Subcommittee on AnaestheticEquipment, under the jurisdiction of the Tec

22、hnical Committee on Anaesthetic Equipment, RespiratoryTechnology, and Critical Care Equipment and the Strategic Steering Committee on Health CareTechnology, and has been formally approved by the Technical Committee. A list of the members of theTechnical Committee is available upon request. This Stan

23、dard has been approved as a National Standardof Canada by the Standards Council of Canada. May 2003 Canadian Standards Association 2003All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission ofthe publisher. ISO material is reprinted wit

24、h 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 should be addressed to Canadian Standards Association 5060 Spectrum Way, Suite 100, Mississauga, Ontar

25、io, Canada L4W 5N61-800-463-6727 416-747-4044www.csa.caMedical suction equipment Part 1: ElectricallyCAN/CSA-Z10079-1-03 powered suction equipment Safety requirementsCSA/2 Canadian Standards Association May 2003Canadian Deviations2 Normative referencesAdd the followingWhere reference is made to CSA

26、Standards, such reference shall be considered to refer to the latestedition and all amendments published to that edition. This Standard refers to the following Standard,and the year shown indicates the latest edition available at the time of printing:CSA (Canadian Standards Association)CAN/CSA-C22.2

27、 No. 601.1.2-94 (R1999)Medical electrical equipment Part 1: General requirements for safety 2. Collateral Standard:Electromagnetic compatibility Requirements and tests3 Terms and definitions3.5 end-piece Replace the note with the followingNote: Examples of commonly used end-pieces are a Yankauer suc

28、ker and a suction catheter.11 Protection against hazards from unwanted or excessiveradiation11.8 Electromagnetic compatibilityReplace this clause with the followingThe requirements given in CAN/CSA-C22.2 No. 601.1.2 shall apply.15 Abnormal operation and fault conditions: environmentaltests15.2 Envir

29、onmental tests53.5 Add the following note Note 1A: If the equipment complies with a temperature range down to 40 C, it should be noted.AReference numberISO 10079-1:1999(E)INTERNATIONALSTANDARDISO10079-1Second edition1999-08-15Medical suction equipment Part 1:Electrically powered suction equipment Sa

30、fety requirementsAppareils daspiration mdicale Partie 1: Appareils lectriques daspiration Prescriptions de scuritISO 10079-1:1999(E) ISO 1999All rights reserved. Unless otherwise specified, no part of this publication may be reproducedor utilized in any form or by any means, electronic or mechanical

31、, including photocopying andmicrofilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 CH-1211 Genve 20 SwitzerlandInternet isoiso.chiiContents1 Scope 12 Normative references 23 Terms and definitions .34 General requirements and general

32、requirements for tests .55 Classification56 Identification, marking and documents.57 Power input 78 Environmental conditions.79 Protection against electric shock hazards810 Protection against mechanical hazards 911 Protection against hazards from unwanted or excessive radiation .1012 Protection agai

33、nst hazards of ignition of flammable anaesthetic mixtures 1013 Protection against excessive temperatures and other safety hazards 1114 Accuracy of operating data and protection against hazardous output .1515 Abnormal operation and fault conditions: environmental tests.1516 Constructional requirement

34、s17Annexes A to L25Annex M (informative) Rationale statement26Annex N (informative) Table of typical ranges of volume for collection containers for specific uses.27Annex O (informative) Lumen (passageway) size and its effects on flow.28 ISOISO 10079-1:1999(E)iiiForewordISO (the International Organiz

35、ation for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established h

36、asthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.Interna

37、tional Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.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

38、 bodies casting a vote.International Standard ISO 10079-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic andrespiratory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.This second edition cancels and replaces the first edition (ISO 10079-1:1991), which

39、has been technically revised.ISO 10079 consists of the following parts, under the general title Medical suction equipment:Part 1: Electrically powered suction equipment Safety requirementsPart 2: Manually powered suction equipmentPart 3: Suction equipment powered from vacuum or pressure sourceAnnexe

40、s A to L of this part of ISO 10079 refer to Appendixes A to L of IEC 60601:1988, respectively. Annexes M, Nand O are for information only.INTERNATIONAL STANDARD ISO ISO 10079-1:1999(E)1Medical suction equipment Part 1:Electrically powered suction equipment Safety requirements1 ScopeThis part of ISO

41、10079 specifies minimum safety and performance requirements for medical and surgical suctionequipment (see Figure 1) for health care facilities such as hospitals, for domiciliary care of patients and for field andtransport use.Although such equipment may be driven by centrally powered piped vacuum s

42、ystems, compressed gases andelectricity, or be manually powered for a variety of applications, this part of ISO 10079 addresses only mainselectricity- and battery-powered suction equipment.NOTE See also annex M in this part of ISO 10079.ISO 10079-1 is one of a series of International Standards based

43、 on IEC 60601-1:1988; in IEC 60601-1 (the“General Standard“), this type of International Standard is referred to as a “Particular Standard“. As stated in 1.3 ofIEC 60601-1:1988, the requirements of this part of ISO 10079 take precedence over those of IEC 60601-1.The scope and object given in clause

44、1 of IEC 60601-1:1988 apply, except that 1.1 shall be replaced by thefollowing:This part of ISO 10079 is not applicable to:a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings,and wall connectors;b) catheter tubes, drains, curettes and suction tips;

45、c) syringes;d) dental suction equipment;e) waste gas scavenging systems;f) laboratory suction;g) autotransfusion systems;h) passive urinary drainage;i) closed systems for wound drainage;j) gravity gastric drainage;k) orally operated mucous extractors;l) suction equipment where the collection contain

46、er is downstream of the vacuum pump;m) equipment marked as suction unit for permanent tracheostomy;n) ventouse (obstetric) equipment;o) neonatal mucous extractors;p) suction equipment marked for endoscopic use only.ISO 10079-1:1999(E) ISO2Key1 Vacuum indicator2 Filter3 Collection container4 Vacuum r

47、egulatorNOTE 1 This part of ISO 10079 applies to mains electricity- and battery-powered suction equipment. Part 2 of ISO 10079applies to manually powered suction equipment. Part 3 of ISO 10079 applies to suction equipment powered from a vacuum orpressure source.NOTE 2 Components illustrated are not

48、necessarily required by this part of ISO 10079.NOTE 3 Suction equipment shown is an example only, and actual systems may consist of other arrangements andcomponents not illustrated.Figure 1 Schematic drawing of suction equipment2 Normative referencesThe following normative documents contain provisio

49、ns which, through reference in this text, constitute provisions ofthis part of ISO 10079. For dated references, subsequent amendments to, or revisions of, any of these publicationsdo not apply. However, parties to agreements based on this part of ISO 10079 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. For undatedreferences, the latest edition of the normative document referred to applies. Members of ISO and IEC main