SIST EN ISO 10535:2007

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

ISO 10535:2006 specifies requirements and test methods only for hoists and body-support units intended for the transfer of disabled persons as classified in ISO 9999:2002:
12 36 03 Mobile hoists with sling seats
12 36 04 Standing mobile hoists
12 36 06 Mobile hoists with solid seats
12 36 09 Hoist trolleys
12 36 12 Stationary hoists fixed to the wall/walls, floor and/or ceiling
12 36 15 Stationary hoists fixed to, mounted in or on another product
12 36 18 Stationary free-standing hoists
12 36 21 Body-support units for hoists
The requirements of ISO 10535:2006 are formulated with regard to the needs of both the disabled persons being hoisted and the attendant using the hoist.

Lifter zum Transport von behinderten Menschen - Anforderungen und Prüfverfahren (ISO 10535:2006)

Diese Internationale  Norm legt Anforderungen und Prüfverfahren für Lifter und Körperstützsysteme für den Transport behinderter Menschen fest, die in ISO 9999:2002 wie folgt klassifiziert sind:
12 36 03   fahrbare Lifter mit Gurtsitzen
12 36 04   fahrbare Stehlifter
12 36 06   fahrbare Lifter mit festen Sitzen
12 36 09   fahrbare Lifter mit Liege
12 36 12   stationäre Lifter mit Decken-, Wand- oder Bodenbefestigung
12 36 15   stationäre Lifter, die in, an oder auf einem anderen Objekt befestigt sind
12 36 18   stationäre, frei stehende Lifter
12 36 21   Körperstützsysteme für Lifter
Diese Internationale Norm gilt nicht für Einrichtungen zum Transport von Personen zwischen zwei Ebenen (Geschossen) eines Gebäudes.
Sie enthält keine Verfahren zur Bestimmung von Alterung oder Korrosion solcher Lifter und Körper-stützsysteme.
Die Anforderungen der vorliegenden Norm sind hinsichtlich der Bedürfnisse sowohl des zu hebenden Behinderten als auch der Hilfsperson, die den Lifter verwendet, formuliert.

Leve-personnes pour transférer des personnes handicapées - Exigences et méthodes d'essai (ISO 10535:2006)

L'ISO 10535:2006 spécifie les exigences et les méthodes d'essai concernant uniquement les lève-personnes et les éléments de soutien destinés au transfert de personnes handicapées, conformément à la classification donnée dans l'ISO 9999:2002:
12 36 03 Lève-personnes mobiles avec sangles
12 36 04 Releveurs mobiles
12 36 06 Lève-personnes mobiles avec sièges
12 36 09 Lève-personne horizontaux
12 36 12 Lève-personnes fixés au mur, entre les murs, au sol et/ou au plafond
12 36 15 Lève-personnes fixés à, montés dans ou sur un autre produit
12 36 18 Lève-personnes fixes simplement posés
12 36 21 Éléments de soutien pour lève-personnes
Les exigences de l'ISO 10535:2006 sont formulées en tenant compte des besoins éprouvés à la fois par les personnes handicapées transportées sur le lève-personne, et par l'accompagnateur utilisant celui-ci.

Dvigala za prestavljanje invalidnih oseb - Zahteve in preskusne metode (ISO 10535:2006)

General Information

• Status: Withdrawn
• Publication Date: 28-Feb-2007
• Withdrawal Date: 02-Dec-2021
• ICS: 11.180.10 - Aids and adaptation for moving
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 02-Dec-2021
• Due Date: 25-Dec-2021
• Completion Date: 03-Dec-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10535:2006 - Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

Relations

• Replaces: SIST EN ISO 10535:2000 - Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:1998)
• Effective Date: 01-Mar-2007
• Replaced By: SIST EN ISO 10535:2022 - Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021)
• Effective Date: 01-Jan-2022
• Child: SIST EN ISO 11334-4:2000 - Walking aids manipulated by one arm - Requirements and test methods - Part 4: Walking sticks with three or more legs (ISO 11334-4:1999)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dvigala za prestavljanje invalidnih oseb - Zahteve in preskusne metode (ISO 10535:2006)Lifter zum Transport von behinderten Menschen - Anforderungen und Prüfverfahren (ISO 10535:2006)Leve-personnes pour transférer des personnes handicapées - Exigences et méthodes d'essai (ISO 10535:2006)Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)11.180.10JLEDQMHAids and adaptation for movingICS:Ta slovenski standard je istoveten z:EN ISO 10535:2006SIST EN ISO 10535:2007en01-marec-2007SIST EN ISO 10535:2007SLOVENSKI
STANDARDSIST EN ISO 10535:20001DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10535December 2006ICS 11.180.10Supersedes EN ISO 10535:1998
English VersionHoists for the transfer of disabled persons - Requirements andtest methods (ISO 10535:2006)Lève-personnes pour transférer des personneshandicapées - Exigences et méthodes d'essai (ISO10535:2006)Lifter für Behinderte - Anforderungen und Prüfverfahren(ISO 10535:2006)This European Standard was approved by CEN on 18 October 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2006 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10535:2006: ESIST EN ISO 10535:2007

Foreword
This document (EN ISO 10535:2006) has been prepared by Technical Committee CEN/TC 293 "Assistive products for persons with disability", 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 of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2007, and conflicting national standards shall be withdrawn at the latest by June 2007.
This document supersedes EN ISO 10535:1998.
This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
ANNEX ZA (informative)
Clauses of this EN addressing essential requirements or other provisions of EU Directives
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this Standard and Directive 93/42/EEC
Clauses/sub-clauses of this European Standard
Corresponding essential requirements of Directive 93/42/EEC
Qualifying remarks/Notes 4 – 10 1 ISO 14971 (risk analysis part) is generally valid 4 – 10 2
4.7, 10.6 3
4.9, 4.10, 5.5, 6.5, 6.6, 10.8, 10.9 4
4 – 10 5 Requirements for packaging not covered. Equivalent clauses of EN 12182:1997 apply. Information supplied by the manufacturer 4.13, 5.6, 6.7, 7.6, 8.4, 9.4, 10.16 4.1.1, 10.1.2 6 ISO 14971 (risk analysis part) is generally valid 4.3.1.4, 8.2, 8.4.2, 9.1, 9.4.2, 10.3.1.2,10.14 7.1 Flammability. Testing according to EN 1021-1:1993, EN 1021-2:1993 4.7.1.2, 4.7.2.2, 10.6 7.2
7.5, 7.6 Equivalent clauses of EN 12182:1997 apply. 4.13.3, 8.4.1, 9.4.2, 10.14, 10.15 8.1
4.3.1.9, 4.3.1.21, 4.4, 4.5, 4.6, 7.2.1.1, 8.1, 8.4, 9.1, 9.4, 10.3.1.2, 10.3.1.4, 10.4, 10.5, 10.14, 10.15 9.1
4 Table ZA.1 (continued)
Clauses/sub-clauses of this European Standard
Corresponding essential requirements of Directive 93/42/EEC
Qualifying remarks/Notes 4.1.1, 4.1.2, 4.3.1.14, 4.3.1.23, 4.9, 5.5, 6.5, 9.2,
10.1.2, 10.1.3, 10.3.1.2, 10.3.1.4, 10.8, 10.15 9.2 ISO 14971 (risk analysis part) is generally valid.
Ergonomics EN 614-1. Part 1 4.3.1.2, 10.3.1.2 9.3 Fire/explosion due to electrical fault (EN 60601-1)
4.13.3, 10.16.3
10.1 Limits of accuracy. 90/384/EEC Non-automatic Weighing Instruments.
4.3.1.2, 10.3.1.2
12.1 Reference to EN 60601-1
4.3.1.16, 10.3.1.2
12.2
4.3.1.23, 10.3.1.4
12.5
4.3.1.2, 10.3.1.2
12.6
4.1.2, 4.3.1.5, 4.4 until 4.11, 5.2 until 5.6, 6.2 until 6.7, 7.2 until 7.6, 8.1 until 8.4, 9.3, 10.1.2, 10.3.1.2, 10.4 until 10.11 12.7.1
4.1.3, 10.1.4
12.7.3 Test regarding sound level according to ISO 3746
4.11, 4.12, 10.11, 10.12
12.7.4
12.7.5 Equivalent clauses of EN 12182:1997 apply.
4.3.1.15, 4.13.1, 4.13.2, 10.3.1.2, 10.16.1,
10.16.2
12.9 EN 980 and EN 1041 ’Information supplied by the manufacturer with medical devices’ are generally valid. For electrical details, EN 60601-1 applies
4.13.1, 4.13.2, 8.4.1, 9.4.1, 10.16.1, 10.16.2 13.1, 13.2, 13.3, 13.4, 13.5 EN 980 and EN 1041 are generally valid.
4.13.3, 5.6, 6.7, 7.6, 8.4.2, 9.4.2,
10.16.3, Annex A
13.6 EN 980 and EN 1041 are generally valid. Annex A for guidance.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Reference numberISO 10535:2006(E)© ISO 2006
INTERNATIONAL STANDARD ISO10535Second edition2006-12-15Hoists for the transfer of disabled persons — Requirements and test methods Lève-personnes pour transférer des personnes handicapées — Exigences et méthodes d'essai
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ii © ISO 2006 – All rights reserved
ISO 10535:2006(E) © ISO 2006 – All rights reserved iiiContents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 General requirements and test methods.7 4.1 General requirements.7 4.2 General test methods.7 4.3 Safety requirements.12 4.4 Requirements for body-support units.17 4.5 Central suspension point.17 4.6 Spreader bar.17 4.7 Performance.17 4.8 Rate (velocity) of lifting and lowering.18 4.9 Operating forces/torques.18 4.10 Durability.19 4.11 Hydraulic components.20 4.12 Pneumatic components.21 4.13 Information supplied by the manufacturer.22 5 Mobile hoists — Specific requirements and test methods.28 5.1 General requirements.28 5.2 Static strength.28 5.3 Static stability.29 5.4 Immobilizing device (brakes).29 5.5 Moving forces.30 5.6 Instructions for use.31 6 Standing and/or raising hoists — Specific requirements and test methods.32 6.1 General requirements.32 6.2 Static strength.32 6.3 Static stability.32 6.4 Immobilizing device (brakes).33 6.5 Moving forces.34 6.6 Durability.34 6.7 Instructions for use.35 7 Stationary hoists — Specific requirements and test methods.35 7.1 General requirements.35 7.2 Specific safety requirements.35 7.3 Static strength (free-standing stationary hoists only).36 7.4 Static stability (free-standing stationary hoists only).36 7.5 Static strength for all other stationary hoists.37 7.6 Instructions for use.38 8 Non-rigid body-support units — Specific requirements and test methods.38 8.1 General requirements.38 8.2 Requirements for material and seams of the non-rigid body-support unit.38 8.3 Test methods for non-rigid body-support unit.38 8.4 Information supplied by the manufacturer.38 9 Rigid body-support units — Specific requirements and test methods.39 SIST EN ISO 10535:2007

ISO 10535:2006(E) iv © ISO 2006 – All rights reserved 9.1 General requirements.39 9.2 Requirements for backrest.39 9.3 Requirements and test methods for durability.39 9.4 Information supplied by the manufacturer.40 10 Bathtub hoists — Specific requirements and test methods.41 10.1 General requirements.41 10.2 General test methods.41 10.3 Safety requirements.42 10.4 Body-support units.42 10.5 Spreader bar.42 10.6 Performance.42 10.7 Rate (velocity) of lifting and lowering.42 10.8 Operating forces.43 10.9 Durability.43 10.10 Static strength and stability.43 10.11 Hydraulic components.44 10.12 Pneumatic components.44 10.13 Specific safety requirements.44 10.14 Non-rigid body-support units.44 10.15 Rigid body-support units — Requirements.44 10.16 Information supplied by the manufacturer.45 Annex A (informative)
Structure of ISO 10535.46 Annex B (informative)
Periodic inspection.47
ISO 10535:2006(E) © ISO 2006 – 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 committees. 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 International 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 casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10535 was prepared by Technical Committee CEN/TC 293, Assistive products for persons with disability, of the European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 173, Assistive products for persons with disability, Subcommittee SC 6, Hoists for transfer of persons, in conformance with the agreement on technical cooperation between ISO and CEN (Vienna Agreement). This second edition cancels and replaces the first edition (ISO 10535:1998), which has been technically revised. SIST EN ISO 10535:2007

ISO 10535:2006(E) vi © ISO 2006 – All rights reserved 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 offers a safe means of supportive lifting and moving, either assisted or independently.
INTERNATIONAL STANDARD ISO 10535:2006(E) © ISO 2006 – All rights reserved 1Hoists for the transfer of disabled persons — Requirements and test methods 1 Scope This International Standard specifies requirements and test methods only for hoists and body-support units intended for the transfer of disabled persons as classified in ISO 9999:2002: ⎯ 12 36 03 Mobile hoists with sling seats ⎯ 12 36 04 Standing mobile hoists ⎯ 12 36 06 Mobile hoists with solid seats ⎯ 12 36 09 Hoist trolleys ⎯ 12 36 12 Stationary hoists fixed to the wall/walls, floor and/or ceiling ⎯ 12 36 15 Stationary hoists fixed to, mounted in or on another product ⎯ 12 36 18 Stationary free-standing hoists ⎯ 12 36 21 Body-support units for hoists This International Standard does not apply to devices that transport persons between two levels (floors) of a building. It does not include methods for the determination of ageing or corrosion of such hoists and units. The requirements of this International Standard are formulated with regard to the needs of both the disabled persons being hoisted and the attendant using the hoist. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 3746, Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane ISO 3758, Textiles — Care labelling code using symbols ISO 9999:2002, Technical aids for persons with disabilities — Classification and terminology ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing ISO 14253-1, Geometrical Product Specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for proving conformance or non-conformance with specifications SIST EN ISO 10535:2007

ISO 10535:2006(E) 2 © ISO 2006 – All rights reserved ISO 14971, Medical devices — Application of risk management to medical devices EN 614-1, Safety of machinery — Ergonomic design 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 hydraulic type — Specification EN 980, Graphical symbols for use in the labelling of medical devices EN 1021-1, Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source: Smouldering cigarette EN 1021-2, Furniture — Assessment of the ignitability of upholstered furniture — Part 2: Ignition source: Match flame equivalent EN 12182:1999, Technical aids for disabled persons — General requirements and test methods EN 13480-3:2002, Metallic industrial piping — Part 3: Design and calculation IEC 60529, Degrees of protection provided by enclosures (IP Code) IEC 60601-1:2006, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2005, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests IEC 61000-3-2, Electromagnetic compatibility (EMC) — Part 3-2: Limits — Limits for harmonic current emissions (equipment input current u 16 A per phase) IEC 61000-3-3 am1, Electromagnetic compatibility (EMC) — Part 3: Limits — Section 3: Limitation of voltage fluctuations and flicker in low-voltage supply systems for equipment with rated current u 16 A IEC 61000-4-3, Electromagnetic compatibility (EMC) — Part 4-3: Testing and measurement techniques — Radiated, radio-frequency electromagnetic field immunity test IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 adverse condition condition in which failure is most likely to occur 3.2 attendant person who operates the hoist if not the lifted person 3.3 backrest part of the body-support unit that supports the back of the person being lifted, transferred or moved along with the associated attachment structure EXAMPLE A body-support unit can be a sling, seat or stretcher. SIST EN ISO 10535:2007

ISO 10535:2006(E) © ISO 2006 – All rights reserved 33.4 backwards 180° to the forwards direction of travel 3.5 bathtub hoist piece of equipment that is specifically designed to be used in or adjacent to a bathtub and with which a disabled person is lifted, transferred or moved 3.6 body-support unit part of the hoist that supports the person being lifted, transferred or moved along with its associated attachment structure EXAMPLE A body-support unit can be a sling, seat or stretcher. 3.7 ceiling hoist overhead mounted hoist system fixed to the ceiling or wall(s), including the tracking system 3.8 central suspension point CSP reference point on the hoist to be used for measurements NOTE This point may be a connecting point. 3.9 connecting point(s) part(s) to which the body-support unit attaches 3.10 control devices part or parts of the hoist which operate the lifting and lowering mechanisms of the CSP as well as other functions EXAMPLE A function can be the leg opening of the mobile base. 3.11 end limiting device device that stops any movement at a predetermined end position 3.12 flexible device component along with any associated joining components that functions as a lifting device EXAMPLE A flexible device can be a chain, tape or rope. 3.13 footrest part of the body-support unit that supports the feet 3.14 forwards intended direction of travel, as indicated by the manufacturer in the instructions for use 3.15 free-standing stationary hoist equipment for transferring by lifting and moving a disabled person in an area limited by the system with the hoist free-standing on the floor SIST EN ISO 10535:2007

ISO 10535:2006(E) 4 © ISO 2006 – All rights reserved 3.16 hoisting
range vertical difference between the maximum and minimum heights of the CSP See Figure 1. 3.17 hoisting
reach unimpeded horizontal distance between the structure and a vertical line through the CSP at a given height within the hoisting range See Figure 1 (b, c). 3.18 hold to run control device control device(s) which initiate and maintain operation of the hoist elements only as long as the manual control is actuated and where the manual control automatically returns to the 'Stop' or 'Off' position when released 3.19 legrest part of the body-support unit that supports the legs 3.20 lifted person person who is transferred by the hoist 3.21 lifting cycle raising and lowering of the lifting machinery for the same distance in both directions 3.22 lifting device means of lifting and lowering the body-support unit 3.23 lifting machinery device that performs the lifting function EXAMPLE The lifting machinery can be a hydraulic, mechanical or electrical apparatus. 3.24 locking gate device that ensures a hoist cannot move from one track to another unless both tracks are in the correct position 3.25 locking system means by which the rigid body-support unit is secured to the hoist 3.26 maximum load greatest permissible load, excluding the body-support unit, that can be applied to the hoist 3.27 mobile hoist piece of equipment, fitted with a device or devices (e.g. wheels) that are freely movable and propellable along the floor, and with which a disabled person is lifted, transferred or moved independent of a fixed installation or other allied device SIST EN ISO 10535:2007

ISO 10535:2006(E) © ISO 2006 – All rights reserved 53.28 multi-purpose hoist piece of equipment that can be assembled, possibly with the use of different parts, to provide a variety of operations 3.29 non-rigid body-support unit device that is manufactured from flexible materials and which adapts to the body shape, with the associated connecting means for attaching to the lifting device of the hoist 3.30 rigid body-support unit preformed seat or recumbent device, manufactured from rigid materials (if necessary padded), or flexible materials encased by a frame, with connecting means for attaching to the lifting device of the hoist 3.31 single fault condition condition in which a single means for reducing the risk resulting from a hazard is defective or a single abnormal condition is present 3.32 sitting part part of the body-support unit that is intended for sitting on 3.33 spreader bar rigid construction with more than one connection point, on to which the body-support unit is attached 3.34 standing and/or raising hoist device to assist the lifting, transferring and moving of a disabled person where some of the mass of the disabled person is supported by some means of footrest 3.35 stationary hoist piece of equipment, with which a person is lifted, transferred or moved within a pre-defined area and which is fixed to a wall, ceiling or floor or is mounted or placed in or on other allied devices, or is free-standing 3.36 turning diameter diameter of the narrowest circle encompassing the extreme points of the hoist, when it is turned 360° without being reversed SIST EN ISO 10535:2007

ISO 10535:2006(E) 6 © ISO 2006 – All rights reserved Dimensions in millimetres
Key 1 highest position 2 maximum reach position 3 lowest position a Maximum reach at 600 mm (reference height). b Maximum reach from base. c Reach from base with legs spread to 700 mm. k Maximum height of CSP. l Minimum height of CSP. m Hoisting range. p Maximum internal width. q Internal width at maximum reach. r Minimum internal width. NOTE Example, schematic presentation only. Figure 1 — Key dimensions of mobile hoist SIST EN ISO 10535:2007

ISO 10535:2006(E) © ISO 2006 – All rights reserved 74 General requirements and test methods 4.1 General requirements 4.1.1 Risk analysis The relevant clauses of ISO 14971 regarding risk analysis apply. 4.1.2 Ergonomic factors Grips, handles and pedals shall suit the functional anatomy of the user, according to the intended use and meet with the following requirements: a) the distance between any handle (part intended to be grabbed) requiring an operating force of more than 10 N and any construction part of the hoist shall not be less than 35 mm; b) the distance between any upper surface of a pedal (in its operating position) and any other part of the hoist shall have a vertical toe clearance of not less than 75 mm; c) the diameter of any operating handles and/or knobs requiring an operating force of more than 10 N shall be between 19 mm and 43 mm; d) for hoists operated from a standing position, pedals shall be placed not more than 300 mm above the surface of the floor; e) for hoists operated from a standing position, hand operated controls shall be placed at a height of 800 mm to 1 200 mm above the floor; f) handles for pushing and/or pulling shall be placed at a minimum height of 900 mm. NOTE Operating controls used by the lifted person may require other positions. For further information on this subject see EN 614-1. 4.1.3 Noise The maximum A-weighted sound power level of the hoist shall be measured in accordance with ISO 3746 during a transfer using the maximum load. This measurement shall also be undertaken with the hoist in an unloaded situation. The results of these measurements shall be stated in the instructions for use. 4.2 General test methods 4.2.1 Test conditions The hoist shall be tested in the as-delivered state (to the customer). However, if the hoist is of a multi-purpose design that can be assembled in different formats, it shall be assembled according to the instructions supplied by the manufacturer. If the hoist is intended to be used in different combinations, then all combinations shall be tested in the most adverse condition. The tests shall be carried out under normal indoor conditions. All tests shall be carried out in the order stated and on one and the same sample hoist. If the hoist is of a multi-purpose design that incorporates a standing and/or raising function, then the durability tests of Clause 5 only shall apply, however the requirements of Clause 5 and Clause 6 shall apply with regard to stability, static strength and push/pulling forces. The test report referred to in 4.2.4 shall be placed in the manufacturer’s technical file. SIST EN ISO 10535:2007

ISO 10535:2006(E) 8 © ISO 2006 – All rights reserved 4.2.2 Test equipment 4.2.2.1 Test surface, rigid, flat, inclinable and with stops preventing the hoist from sliding but not tilting. 4.2.2.2 Stops no smaller than half of the wheel diameter and no greater than the wheel diameter. 4.2.2.3 Loads suitable for the loading of hoists and body-support units, e.g. cylindrical load(s), made of steel with rounded edges, (not less than R25) and with diameter 350 mm. For the testing of non-rigid body-support units the load can be made to represent the proposed body to be lifted. 4.2.2.4 Equipment capable of simulating use in practice (e.g., test fingers). 4.2.2.5 Equipment for applying loads, with negligible dynamic factor. 4.2.2.6 Sound level meter in accordance with IEC 61672-1. 4.2.2.7 Equipment for measuring pressure of water, oil and air. 4.2.2.8 Device for applying loads to standing and/or raising hoists (see Figure 2). The centre of gravity of the load shall be positioned as indicated and the centre of gravity shall be able to move as demonstrated by the joints. 4.2.2.9 Device for applying loads to rigid body support units [see Figures 3, 4 a) and 4 b]. 4.2.3 Permissible errors of test equipment The following maximum permissible error(s) of test equipment apply: ⎯ pressures
± 5 % ⎯ forces/loads
± 5 % ⎯ velocities
± 5 % ⎯ angles
± 0,25° ⎯ dimensions u 100 mm ± 0,5 mm ⎯ dimensions > 100 mm ± 0,5 % ⎯ time
± 0,1 s For proving conformance or non-conformance with this specification, the procedures in accordance with ISO 14253-1 shall apply. 4.2.4 Test report The test report shall include at least the following information: a) a reference to this International Standard, i.e. ISO 10535:2006; b) a description of the product, including type, designation and serial number; c) name and address of the manufacturer; d) a photograph of the hoist equipment as presented during test; e) the name and address of the testing laboratory; SIST EN ISO 10535:2007

ISO 10535:2006(E) © ISO 2006 – All rights reserved 9f) the stability values to the nearest 0,5° rounded down; g) result of tests including record of maintenance, if any; h) any deviations from the standardized test procedure; i) date of test; j) test conditions regarding humidity and temperature. Dimensions in millimetres
a Centre of gravity. Figure 2 — Test dummy for standing and/or raising hoists SIST EN ISO 10535:2007

ISO 10535:2006(E) 10 © ISO 2006 – All rights reserved
Key X width in millimetres Y load in kilogrammes 1 backrest a Width, in millimetres = 2 × maximum load in kilogrammes. b Height = 200 mm. c Centre of gravity. NOTE Dimension “a” starts where dimension “b” contacts the backrest. Figure 3 — Placing of loads on rigid body-supports SIST EN ISO 10535:2007

ISO 10535:2006(E) © ISO 2006 – All rights reserved 11Dimensions in millimetres
Key 1 feet 2 head 3 base a)
Front elevation
a Width, in millimetres = 2 × maximum load. b Height = 200 mm. c Centre of gravity. NOTE Dimension “a” starts where dimension “b” contacts the backrest. b)
Side elevation Figure 4 — Placing of loads on fixed stretcher SIST EN ISO 10535:2007

ISO 10535:2006(E) 12 © ISO 2006 – All rights reserved 4.3 Safety requirements 4.3.1 Safety and performance requirements 4.3.1.1 Every hoist shall be capable of lifting a person of 120 kg mass excluding the mass of any body-support unit. 4.3.1.2 Electrically operated hoists shall conform to IEC 60601-1 regarding electrical safety unless requirements are covered by this International Standard. For electrical safety covered by both standards, the requirements of this International Standard prevail over the ones given in IEC 60601-1. 4.3.1.3 The manufacturer shall ensure that the choice of materials used in the construction of the hoist shall be well suited to the intended area of use. 4.3.1.4 Materials which come into contact with the human body shall be assessed for biocompatibility using the guidance given in ISO 10993-1. The assessment shall take into account the intended use and contact by the users. 4.3.1.5 All load-bearing fasteners shall be either self-locking or fitted with a locking device to prevent inadvertent detachment. 4.3.1.6 Single use components (e.g. wood screws or self-tapping screws), shall not be used for the assembly of any component that is intended to be removed for the purpose of dismantling for transport or storage. 4.3.1.7 Handgrips shall be fixed in such a manner as to prevent inadvertent detachment. 4.3.1.8 Unless required for a specific function of the hoist, all accessible edges, corners and surfaces shall be smooth and have no burrs or sharp edges. All projections shall be avoided or fitted with adequate protection to prevent damage or injury. 4.3.1.9 It shall not be possible to assemble the hoist in a manner which affects the overall safety of the unit. If the lifting device incorporates a mast, it shall be so located in relation to its base that it can only be assembled or adjusted in the correct safe working position. If the design of the hoist is such that the load is allowed to move in a horizontal manner, then the hoist shall not move or operate unless the hoist has been properly secured to prevent inadvertent tipping. 4.3.1.10 Protection against shearing, crushing, trapping and abrading shall be provided and shall be in accordance with the requirements of IEC 60601-1. 4.3.1.11 The hoist shall include in its design some means (e.g., limiting switches, the principal of free-wheeling, etc.) that will ensure that, when lowering, should the spreader bar or lifting arm come into contact with the lifted person, the total load imposed on the lifted person shall not be greater than the total mass of those parts and shall not increase by more than 50 N due to the lifting machinery of the hoist. 4.3.1.12 When a hoist is used in accordance with the manufacturer’s instructions, should a part of a person become trapped during a horizontal transfer, then the total force imposed on that person shall not increase by more than 100 N due to the machinery of the hoist. 4.3.1.13 When operated, the means provided in 4.3.1.11 shall not allow the hoist to become unsafe. 4.3.1.14 All controls, for lowering or raising the lifted person, shall be easily accessible and operable by the person operating the hoist. 4.3.1.15 Electrically operated hoists shall be provided with an emergency device that is readily accessible and is intended to isolate the power supply and to stop any electrically produced mechanical movement which could cause a safety hazard. SIST EN ISO 10535:2007

ISO 10535:2006(E) © ISO 2006 – All rights reserved 13Resetting the emergency device shall only be possible as the result of a manual action on the emergency device itself. The action of resetting shall be different to the action of activation. The emergency device shall be coloured red. 4.3.1.16 On all battery-powered hoists, a warning device(s) shall be provided that will indicate when the battery(ies) require charging. When this device operates there shall be sufficient power available to complete one full lifting cycle with maximum load. 4.3.1.17 All controls shall be of the 'hold to run' type. 4.3.1.18 The hoist shall be designed in such a way so that it shall not lift more than 1,5 × the maximum load. 4.3.1.19 Hoists shall be provided with a safety device that shall ensure that the lifted person does not fall in the event of a single-fault condition of the lifting machinery. See 4.7 and 9.8.2 of IEC 60601-1:2006. 4.3.1.20 After the static test, in accordance with 4.3.2.20, any flexible device shall show no sign of damage that will affect the function of the hoist as stated by the manufacturer. 4.3.1.21 A connection point shall be so designed that the body-support unit shall not become inadvertently detached. 4.3.1.22 Where necessary, all precautions shall be taken [e.g. by the fitting of a safety devices(s)] to protect the lifted person from inadvertently falling off/from the body-support unit. 4.3.1.23 Electrically operated hoists shall fulfill the requirements specified in IEC 60601-1-2 and shall in addition fulfill the following: a) Emission The requirements of IEC 61000-3-2 apply if applicable as specified in IEC 61000-3-2. The requirements of IEC 61000-3-3-am1 apply if applicable as specified in IEC 61000-3-3-am1. b) Immunity Requirements are only applicable to hoists containing electronic devices/components. Electrical motors, mechanical switches and other passive components are not considered electronic devices/components. In addition to the requirements of IEC 60601-1-2:2005, Clause 36.202.2.1, the hoist shall also be tested with a field strength of 10V/m (RMS value of the unmodulated carrier) in the frequency range of 800 MHz to 2 GHz. The test shall be performed in accordance with IEC 61000-4-3. If as a result of the application of this test the hoist becomes dangerous or unsafe, the hoist shall be deemed to have failed the test. Furthermore, any unintentional movement of any part of the hoist during the test is not allowed. It is necessary to assess the risk associated with the hoist when used in close proximity to a mobile telephone or other form of transmitter. NOTE 1 In this case higher field strength values over a broader range of frequency may apply. NOTE 2 Hoists are used in a wide range of environments and may be used in the presence of other electrical equipment. The electromagnetic compatibility (EMC) needs to be carefully matched to the intended use of the hoist. SIST EN ISO 10535:2007

ISO 10535:2006(E) 14 © ISO 2006 – All rights reserved 4.3.1.24 Any electrical component that can be splashed, during ’normal’ operation shall have an IP rating of at least IP×4. Any electrical component that can be submerged during normal operation shall have an IP rating of at least IP×7. 4.3.1.25 The connection point(s) shall be smooth, thus avoiding excessive wear of any connectors. 4.3.1.26 Where a stretcher system is suspended from the CSP of the hoist, the stretcher shall be marked to ensure that the patient is correctly positioned according to the intended use as stated by the manufacturer (eg., head end/foot end) For an example of marking of stretcher, see Figure 5.
Figure 5 — Example of marking of stretcher 4.3.2 Test methods for general safety requirements 4.3.2.1 The requirements described in 4.3.1.1 shall be confirmed through practical test and inspection. 4.3.2.2 The requirements described in 4.3.1.2 shall be determined by verification in accordance with IEC 60601-1. 4.3.2.3 The requirements described in 4.3.1.3 shall be determined through inspection. 4.3.2.4 The result of the assessment for biocompatibility will provide verification methods. 4.3.2.5 The requirements described in 4.3.1.5 shall be determined through inspection. 4.3.2.6 The requirements described in 4.3.1.6 shall be determined through inspection. SIST EN ISO 10535:2007

ISO 10535:2006(E) © ISO 2006 – All rights reserved 154.3.2.7 The requirement described in 4.3.1.7 shall be determined by testing as follows, according to the following procedure: a) with the hoist standing on a horizontal and smooth test plane, set up the 'loading meth
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