1、National Standard of CanadaCAN/CSA-Z10535-03International Standard ISO 10535:1998 (first edition, 1998-10-15) has been adopted with Canadian deviations(MOD) as CSA Standard CAN/CSA-Z10535-03, which has been approved as a National Standard of Canada by theStandards Council of Canada.ISBN 1-55397-477-
2、8 October 2003The Canadian Standards Association (CSA), The Standards Council 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 Standard
3、s Council of Canada to the National organizations working towards the furtherStandards 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 certific
4、ation The principal objects of the Council are to foster activities. and promote 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,
5、 assisting consumers, retailers, unions and professional and protecting the 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
6、often adopted by municipal, provincial, and A National Standard of Canada 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 t
7、he environment. agreement among the views of a number of capableIndividuals, 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 ski
8、lls to representation of producers, users, consumers, andCSA Committee work 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
9、 2000 which is capable of making a significant and timelysustaining memberships 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 ind
10、icates that a standard conforms to theincome for CSAs standards development 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 co
11、ntent of the standard; this remains thestandards development activities. To 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
12、 apply standards arethat bear the CSA Mark. encouraged to use National Standards 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 ce
13、ntres across Canada and inspection and testing to obtain the latest edition 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: CS
14、A is an independent of Canada rests with theservice organization whose mission 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, certifi
15、cation and related services to meet Canadanational and international needs.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 i
16、ntended 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.Registered trade-mark of Canadian Standards AssociationStandards Update ServiceCAN/CSA-Z10535-03October 20
17、03Title: Hoists for the transfer of disabled persons Requirements and test methodsPagination: 56 pages (CSA/1CSA/14, ivi, and 36 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 up
18、dates to this publication is 2015576.If you require 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.Hoists for the transfer of disabled persons CAN/CSA-Z10535-03 Requi
19、rements and test methods October 2003 Canadian Standards Association CSA/1 CAN/CSA-Z10535-03 Hoists for the transfer of disabled persons Requirements and test methods CSA Preface This is the first edition of CAN/CSA-Z10535, Hoists for the transfer of disabled persons Requirements and test methods, w
20、hich is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 10535 (first edition, 1998-10-15). It replaces CAN/CSA-Z323.5-98, Mechanical/Electromechanical Lifting Devices for Persons. Numerous reports of injuries and deaths r
21、esulting from the malfunction, failure, or misuse of lifting devices for health care facility patients and other persons have provided the impetus for adopting this Standard (see Annex ZZA in the Canadian Deviations to this Standard). This Standard was reviewed for Canadian adoption by the CSA Subco
22、mmittee on Lifting Devices, under the jurisdiction of the Technical Committee on Technology for Persons with a Disability and the Strategic 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 ava
23、ilable upon request. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada. October 2003 Canadian Standards Association 2003 All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the pub
24、lisher. 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 should be addressed to Canadian Standards Association 5060 Spect
25、rum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N6 1-800-463-6727 416-747-4044 www.csa.ca Hoists for the transfer of disabled persons CAN/CSA-Z10535-03 Requirements and test methods CSA/2 Canadian Standards Association October 2003 CSA Foreword The Canadian Standards Association (CSA) develops
26、 standards under the name Canadian Standards Association, and provides certification and testing under the name CSA International. CSA International provides certification services for manufacturers who, under license from CSA, wish to use the appropriate registered CSA Marks on certain products of
27、their manufacture to indicate conformity with CSA Standards. CSA Certification for a number of products is provided in the interest of maintaining agreed-upon standards of quality, performance, interchangeability and/or safety, as appropriate. Where applicable, certification may form the basis for a
28、cceptance by inspection authorities responsible for enforcement of regulations. Where feasible, programs will be developed for additional products for which certification is desired by producers, consumers, or other interests. In performing its functions in accordance with its objectives, CSA does n
29、ot assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and findings of the Association represent its professional judgement given with due consideration to the necessary limitations of practical operation and state of the art at the time the Stand
30、ard is processed. Products in substantial accord with this Standard but which exhibit a minor difference or a new feature may be deemed to meet the Standard providing the feature or difference is found acceptable utilizing appropriate CSA International Operating Procedures. Products that comply with
31、 this Standard shall not be certified if they are found to have additional features which are inconsistent with the intent of this Standard. Products shall not be certifiable if they are discovered to contravene applicable laws or regulations. Testing techniques, test procedures, and instrumentation
32、 frequently must be prescribed by CSA International in addition to the technical requirements contained in Standards of CSA. In addition to markings specified in the Standard, CSA International may require special cautions, markings, and instructions that are not specified by the Standard. Some test
33、s required by CSA Standards may be inherently hazardous. The Association neither assumes nor accepts any responsibility for any injury or damage that may occur during or as the result of tests, wherever performed, whether performed in whole or in part by the manufacturer or the Association, and whet
34、her or not any equipment, facility, or personnel for or in connection with the test is furnished by the manufacturer or the Association. Manufacturers should note that, in the event of the failure of CSA International to resolve an issue arising from the interpretation of requirements, there is an a
35、ppeal procedure: the complainant should submit the matter, in writing, to the Secretary of the Canadian Standards Association. If this Standard is to be used in obtaining CSA Certification please remember, when making application for certification, to request all current Amendments, Bulletins, Notic
36、es, and Technical Information Letters that may be applicable and for which there may be a nominal charge. For such information or for further information concerning CSA Certification, please address your inquiry to Applications and Customer Service, CSA International, 178 Rexdale Boulevard, Toronto,
37、 Ontario, Canada M9W 1R3. Hoists for the transfer of disabled persons CAN/CSA-Z10535-03 Requirements and test methods October 2003 Canadian Standards Association CSA/3 Canadian Deviations 1 Scope Add the following note below the first paragraph Note: In this Standard, “hoist” means a device for lift
38、ing persons. Delete the second-last paragraph 2 Normative references Add the following These National Standards of Canada, published by the Canadian Standards Association, are adoptions of IEC Standards. The requirements of these CSA Standards shall take precedence over the International Standards o
39、n which they are based. Any reference in CAN/CSA-Z10535 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 Requirements for Safety CAN/CSA-C22.2 No. 60601-1-2:03 Medical
40、electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests 4 General requirements and test methods 4.1.2 Ergonomics factors etc Replace the first paragraph with the following Note 1A: The ergonomics of the hoist should be
41、based on the requirements of EN 614-1. 4.3 General safety requirements 4.3.3 Replace this clause with the following When a chair or rigid seat is used to support the person being lifted and is attached to the lifting device, the method used to connect the two shall have a locking mechanism that is (
42、a) self locking; (b) protected against inadvertent unlocking by the operator, the person being lifted, or objects (e.g., towels or clothing) that could interfere with its proper operation; (c) of the latching type and requires two independent operations to release; and (d) not subject to jarring loo
43、se if the chair or rigid seat hits an obstruction (e.g., the upper edge of a bathtub while the chair or rigid seat is being lowered). Hoists for the transfer of disabled persons CAN/CSA-Z10535-03 Requirements and test methods CSA/4 Canadian Standards Association October 2003 4.11 Information supplie
44、d by the manufacturer 4.11.1 General Delete this clause 4.13A Corrosion protection Add the following clause A lift that is intended to be used in a humid environment shall be protected against rusting and corrosion (see Annex ZZB). Note: There have been several reports of the base plate of fixed flo
45、or lifts failing because of high humidity and the corrosiveness of cleaning and disinfecting agents used in bathrooms where the lifts are located. Therefore, use of cleaning and disinfecting agents in proper concentrations, along with proper inspection and maintenance, is essential to ensure the str
46、uctural integrity of bathing, therapeutic, aquatic rehabilitation, and other lifts used in bathrooms and other rooms where there is high humidity or cleaning and disinfecting agents are used. Hoists for the transfer of disabled persons CAN/CSA-Z10535-03 Requirements and test methods October 2003 Can
47、adian Standards Association CSA/5 Add the following annex Annex ZZA (informative) Medical devices alert Notes: (1) This annex is not a mandatory part of this Standard. (2) Source: Medical Devices Alert No. 109, Health Canada, March 20, 1997, and Addendum, January 2001 . Adapted and reproduced with t
48、he permission of the Minister of Public Works and Government Services Canada, 2003. Health Canada assumes no responsibility for any errors or omissions which may have occurred in the adaptation of its material. ZZA.1 Health Canadas Medical Devices Alert No. 109 and its Addendum are reproduced on the
49、 following pages. Hoists for the transfer of disabled persons CAN/CSA-Z10535-03 Requirements and test methods CSA/6 Canadian Standards Association October 2003 March 20, 1997. No. 109TO: Hospital and nursing home administrators and home care providers.To the attention of: nursing, CCU/ICU, biomedical engineering, maintenance, occupational health and safety, materiel management, housekeeping and laundry staff.SUBJECT: Incidents involving patient liftsSince 1981, Health Canada has received reports of 11 deaths and o
