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1、BRITISH STANDARD BS EN ISO 10535:1998 Hoists for the transfer of disabled persons Requirements and test methods The European Standard EN ISO 10535:1998 has the status of a British Standard ICS 11.180 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:58 GMT+00:00 2006, Uncontrolled Copy, (
2、c) BSI BS EN ISO 10535:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 December 1998 BSI 05-1999 ISBN 0 580 30325 X National foreword This Bri
3、tish Standard is the English language version of EN ISO 10535:1998. The UK participation in its preparation was entrusted to Technical Committee CH/31, Hospital furniture, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committ
4、ee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-referen
5、ces Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement international or European publications referred to in this
6、document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users
7、of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, pages 2 to 24 and a
8、back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:58
9、GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10535:1998 BSI 05-1999i Contents Page National forewordInside front cover Foreword2 Text of EN ISO 105355 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldu
10、n sheffieldun, na, Wed Nov 15 13:00:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10535 October 1998 ICS 11.180 Descriptors: Disabled persons, lifting equipment, specifications, safety, accident prevention, definitions, ergonomics, performance
11、 evaluation, mechanical properties, mechanical strength, stability, control devices, routine verification, marking English version Hoists for the transfer of disabled persons Requirements and test methods (ISO 10535:1998) Lve-personnes pour transfrer des personnes handicapes Exigences et mthodes des
12、sai (ISO 10535:1998) Lifter Anforderungen und Prfverfahren (ISO 10535:1998) This European Standard was approved by CEN on 27 May 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national s
13、tandard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any othe
14、r language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Gr
15、eece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All righ
16、ts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10535:1998 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10535:1998 BSI 05-1999 2 Foreword The text of EN ISO 10535:1998
17、has been prepared by Technical Committee CEN/TC 293 “Technical aids for disabled persons”, the secretariat of which is held by SIS, in collaboration with Technical Committee ISO/TC 173 “Technical systems and aids for disabled or handicapped persons”. This European Standard shall be given the status
18、of a national standard, either by publication of an identical text or by endorsement, at the latest by April 1999, and conflicting national standards shall be withdrawn at the latest by April 1999. This European Standard has been prepared under a mandate given to CEN by the European Commission and t
19、he European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex Z, which is an integral part of this standard. This standard provides one means to demonstrate that hoists for the transfer of disabled persons, wh
20、ich are also medical devices, conform to the essential requirements outlined in general terms in Annex 1 of the EU Directive 93/42 EEC. It is not intended to provide a means to show conformity with the requirements of any other directive. There are three levels of European Standards dealing with tec
21、hnical aids for disabled persons. These are as follows, with level 1 being the highest: Level 1: General requirements for technical aids Level 2: Particular requirements for families of technical aids Level 3: Specific requirements for types of technical aids. Where standards for particular aids or
22、groups of aids exist (level 2 or 3), the requirements of lower level standards take presedence over higher level standards. Therefore, to address all requirements for a particular aid, it is necessary to start with standards of the lowest available standard. This is a combined level 2- and 3-standar
23、d (lowest possible) for hoists for the transfer of disabled persons, as specified in the scope. Clause 4 of this standard contains requirements and test methods applicable to all relevant types of hoists. Clause 5 contains additional requirements and test methods for mobile hoists. Clause 6 contains
24、 additional requirements and test methods for stationary hoists. Clause 7 contains additional requirements and test methods for non rigid body supports units. Clause 8 contains additional requirements and test methods for rigid body supports units Clause 9 contains additional and modified requiremen
25、ts and test methods for hoists that are intended to be free standing within the bathtub. NOTE 1Clause 9 is under consideration. Annex A is included to offer information regarding the periodic examination and inspection of hoist equipment. Annex B is included to assist the manufacturer and purchaser
26、with regard to the category into which certain hoists can fall. Annex C is included to give specific requirements and testing for hydraulics and pneumatics. Annex Z is included to show the parts of this European Standard which addresses the essential requirements of EU Directive 93/43/EEC. NOTE 2Thi
27、s standard is valid as a combined level 2/3-standard within the 3-level system used in the European standardization for medical devices concerning technical aids for disabled persons. This standard is an International Standard as well (ISO 10535). The use or the status as an International Standard i
28、s not affected by the European 3-level system. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Irela
29、nd, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10535:1998 BSI 05-19993 Contents Page Foreword2 Introduction5 1Scope5 2Normative
30、references5 3Definitions5 4General requirements and test methods7 4.1General requirements7 4.1.1Risk analysis7 4.1.2Ergonomics factors etc.7 4.1.3Sound level7 4.2General test conditions 7 4.2.1Test conditions7 4.2.2Test equipment7 4.2.3Tolerances8 4.2.4Test report8 4.3General safety requirements8 4.
31、4Test methods for general safety requirements9 4.5Requirements for performance10 4.6Test methods for performance10 4.7Requirements for rate (velocity) of lifting and lowering10 4.8Test methods for rate (velocity) of lifting and lowering10 4.9Requirements for operating forces10 4.10Test methods for o
32、perating forces10 4.11Information supplied by the manufacturer10 4.11.1 General10 4.11.2 Marking10 4.11.3 Instructions for use11 4.12Requirements for durability11 4.13Test methods for durability11 5Mobile hoists Specific requirements and test methods11 5.1Requirements for static strength11 5.2Test m
33、ethods for static strength12 5.3Requirements for static stability12 5.4Test methods for static stability12 5.5Requirements for immobilizing device (brakes)12 5.6Test methods for immobilizing device (brakes)12 5.7Requirements for moving forces12 Page 5.8Test methods for moving forces12 5.9Instruction
34、s for use12 6Stationary hoists Specific requirements and test methods13 6.1Specific safety requirements13 6.2Test methods for specific safety requirements13 6.3Requirements for static strength for all other stationary hoists13 6.4Requirements for static strength (free standing hoists only)13 6.5Test
35、 methods for static strength (free-standing stationary hoists only)13 6.6Requirements for static stability (free-standing stationary hoists only)13 6.7Test methods for static stability (free-standing stationary hoists only)14 6.8Requirements for static strength for all other stationary hoists14 6.9T
36、est methods for static strength for all other stationary hoists14 6.10 Instructions for use14 7Non-rigid body support units Specific requirements and test methods14 7.1General14 7.2Requirements for the central suspension point14 7.3Test method for the central suspension point14 7.4Requirements for t
37、he spreader bar14 7.5Test methods for the spreader bar 14 7.6Requirements for the non-rigid body support unit15 7.7Material and seams of the non-rigid body support unit15 7.8Test methods for body support unit15 7.9Marking15 7.10 Instructions for use15 8Rigid body support units Specific requirements
38、and test methods15 8.1General15 8.2Requirement for backrest15 8.3Requirements and test methods for durability15 8.4Marking15 8.5Instructions for use16 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10535:1998 BSI 05-1999 4 Page 9Free
39、-standing hoists for use in bath tubs16 Annex A (informative) Periodic inspection21 Annex B (informative) Applications21 Annex C (normative) Hydraulic and pneumatic components requirements and test methods21 Annex Z (informative) Clauses of this European Standard addressing essential requirements or
40、 other provisions of EU Directives22 Figure 1 Example of forward stability test16 Figure 2 Placing of loads on rigid body supports17 Figure 3 Placing of loads on stretcher17 Figure 4 Base height/clearance17 Figure 5 Base (Parallel type)18 Figure 6 Base (Radial type)18 Figure 7 Hoisting range/reach19
41、 Figure 8 Hoisting range (ceiling hoist)19 Figure 9 Stability test for free-standing stationary hoist20 Figure 10 Handgrip loading methods20 Table Z.1 Correspondence between this European Standard and EU Directives23 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:58 GMT+00:00 2006, Unc
42、ontrolled Copy, (c) BSI EN ISO 10535:1998 BSI 05-19995 Introduction It appears from studies that the nursing and caring profession involves many physically burdening factors in the caring for and nursing of disabled persons. A hoist may constitute a useful means for preventing overloading of the att
43、endant and the disabled person. 1 Scope This European standard specifies requirements and test methods only for hoists and body support units intended for the transfer of disabled persons as classified in EN ISO 9999:1998: This standard does not apply to devices that transports persons between two l
44、evels (floors) of a building. This standard does not include methods for determination of ageing or corrosion of such hoists and units. The requirements of this standard are formulated with regard to the needs of both the disabled persons being hoisted and the attendant using the hoist. 2 Normative
45、references This European standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any o
46、f these publications apply to this European standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 292, Safety of machinery. Basic concepts, general principles for design Part 1: Basic terminology, methodol
47、ogy Part 2: Technical principles and specification. EN 614-1, Safety of machinery. Ergonomic principles Part 1: Terminology and general principles. EN 853, Rubber hoses and hose assemblies Wire braid reinforced hydraulic type Specification. EN 854, Rubber hoses and hose assemblies Textile reinforced
48、 hydraulic type Specification. EN 980, Graphical symbols for the use in the labelling of medical devices. EN 1021-1:1993, Assessment of the ignitability of upholstered furniture Part 1: Ignition source: Smouldering cigarette. EN 1041, Information supplied by the manufacturer with medical devices. EN
49、 1441, Medical devices Risk analysis. EN ISO 9999:1998, Technical aids for disabled persons Classification. EN 60601-1, Medical electrical equipment Part 1: General requirements for safety. EN 60601-1-2, Electromagnetic compatibility Requirements and tests. prEN 12182:1997, Technical aids for disabled persons General requirements and test methods. ISO 3741:1988, Acoustics Determination of sound power levels of noise sources Precision methods for broad band sources in reverberation rooms. ISO 3
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