EN ISO 10535:2021
(Main)Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021, Corrected version 2023-08)
Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021, Corrected version 2023-08)
This document specifies requirements and test methods for hoists and body-support units intended for the transfer of persons with disabilities. The document applies to the following products classified in ISO 9999:—[1].
— 12 36 03 Mobile hoists for transferring a person in sitting position with sling seats;
— 12 36 04 Mobile hoists for transferring a person in standing position;
— 12 36 06 Mobile hoists for transferring a person in sitting position with solid seats;
— 12 36 09 Mobile hoists for transferring a person in lying position;
— 12 36 12 Stationary hoists fixed to walls, floor or ceiling;
— 12 36 15 Stationary hoists fixed to, or mounted in or on, another product;
— 12 36 18 Stationary free-standing hoists;
— 12 36 21 Body-support units for hoists.
This document covers different types of mobile and stationary hoists. Some of the requirements and test methods are general and others are only valid for specific product types.
Annexes A, B and C provide general recommendations.
This document 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.
It does not include methods to qualify individual units prior to use.
The requirements of this document are formulated with regard to the needs of both the persons being hoisted and the attendant using the hoist.
[1] Under preparation. Stage at the time of publication: ISO/FDIS 9999:2021.
Hilfsmittel - Lifter zum Transfer von Menschen mit Behinderungen - Anforderungen und Prüfverfahren (ISO 10535:2021, korrigierte Fassung 2023-08)
Dieses Dokument legt Anforderungen und Prüfverfahren für Lifter und Körperstützsysteme für den Transport von Personen mit Behinderungen fest. Das Dokument gilt für die folgenden in ISO 9999:— klassifizierten Produkte.
— 12 36 03 fahrbare Lifter mit Gurtsitzen für den Transfer einer Person in sitzender Position;
— 12 36 04 fahrbare Stehlifter;
— 12 36 06 fahrbare Lifter mit festen Sitzen für den Transfer einer sitzenden Person;
— 12 36 09 fahrbare Lifter für den Transfer einer Person im Liegen;
— 12 36 12 stationäre Lifter mit Wand-, Boden- oder Deckenbefestigung;
— 12 36 15 stationäre Lifter, die in, an oder auf einem anderen Objekt befestigt sind;
— 12 36 18 stationäre, freistehende Lifter;
— 12 36 21 Körperstützsysteme für Lifter.
Dieses Dokument behandelt verschiedene Arten von fahrbaren und stationären Liftern. Einige der Anforderungen und Prüfverfahren sind allgemein und andere sind nur für bestimmte Produkttypen gültig.
Anhang A, Anhang B und Anhang C enthalten allgemeine Empfehlungen.
Dieses Dokument ist nicht anzuwenden für Einrichtungen zum Transport von Personen zwischen zwei Ebenen (Geschossen) eines Gebäudes.
Es enthält keine Verfahren zur Bestimmung von Alterung oder Korrosion solcher Lifter und Körperstützsysteme.
Es enthält keine Verfahren zur Qualifizierung einzelner Körperstützsysteme vor der Verwendung.
Die Anforderungen des vorliegenden Dokuments sind hinsichtlich der Bedürfnisse sowohl des zu hebenden Menschen als auch der Hilfsperson, die den Lifter verwendet, formuliert.
Produits d'assistance - Lève-personnes pour transférer des personnes - Exigences et méthodes d'essais (ISO 10535:2021, Version corrigée 2023-08)
Le présent document spécifie les exigences et les méthodes d'essai concernant les lève-personnes et les éléments de soutien du corps destinés au transfert des personnes en situation de handicap. Le document s'applique aux produits suivants, conformément à la classification donnée dans l'ISO 9999:—[1].
— 12 36 03 Lève-personnes mobiles avec sangles permettant de transférer une personne en position assise.
— 12 36 04 Lève-personnes mobiles permettant de transférer une personne en position debout.
— 12 36 06 Lève-personnes mobiles avec siège rigide permettant de transférer une personne en position assise.
— 12 36 09 Lève-personnes mobiles permettant de transférer une personne en position allongée.
— 12 36 12 Lève-personnes fixés aux murs, au sol 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 du corps pour lève-personnes.
Le présent document couvre différents types de lève-personnes mobiles et fixes. Certaines exigences et méthodes d'essai s'appliquent à tous les produits, d'autres ne sont valables que pour certains types spécifiques de produits.
Les Annexes A, B et C fournissent des recommandations générales.
Le présent document ne s'applique pas aux dispositifs destinés au transport de personnes entre deux niveaux (ou étages) d'un bâtiment.
Il ne décrit pas les méthodes relatives à la détermination du vieillissement ou de la corrosion des lève-personnes et des éléments cités.
Il n'inclut pas de méthodes permettant de qualifier les éléments particuliers avant leur utilisation.
Les exigences du présent document sont formulées en tenant compte des besoins éprouvés à la fois par les personnes transportées sur le lève-personne et par l'accompagnateur utilisant celui-ci.
[1] En cours d'élaboration. Stade à la date de publication: ISO/FDIS 9999:2021.
Tehnični pripomočki - Dvigala za prestavljanje oseb - Zahteve in preskusne metode (ISO 10535:2021)
Ta mednarodni standard določa zahteve in preskusne metode samo za dvigala in enote za podporo telesa, namenjene za prestavljanje invalidnih oseb v skladu z razvrstitvijo v standardu ISO 9999:2002:
⎯ 12 36 03 Mobilna dvigala z vrečo
⎯ 12 36 04 Stoječa mobilna dvigala
⎯ 12 36 06 Mobilna dvigala s sedežem
⎯ 12 36 09 Dvižni vozički
⎯ 12 36 12 Stacionarna dvigala, pritrjena na steno/stene, tla in/ali strop
⎯ 12 36 15 Stacionarna dvigala, pritrjena/nameščena v/na drug izdelek
⎯ 12 36 18 Stacionarna prosto stoječa dvigala
⎯ 12 36 21 Enote za podporo telesa za dvigala
Ta mednarodni standard se ne uporablja za pripomočke za prestavljanje oseb med dvema etažama (nadstropjema) stavbe.
Ne vključuje metod za določitev staranja ali korozije takšnih dvigal in enot.
Zahteve tega mednarodnega standarda so oblikovane glede na potrebe invalidov, ki se jih dviguje, in tudi upravljavca dvigala.
General Information
- Status
- Published
- Publication Date
- 02-Nov-2021
- Withdrawal Date
- 30-May-2022
- Technical Committee
- CEN/TC 293 - Technical aids for disabled persons
- Drafting Committee
- CEN/TC 293 - Technical aids for disabled persons
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 03-Nov-2021
- Due Date
- 04-Nov-2019
- Completion Date
- 03-Nov-2021
Relations
- Effective Date
- 10-Nov-2021
Overview - What EN ISO 10535:2021 (ISO 10535:2021) covers
EN ISO 10535:2021 specifies requirements and test methods for hoists and body‑support units used to transfer persons with disabilities. It applies to a range of assistive products classified in ISO 9999, including mobile hoists for sitting, standing and lying transfers, stationary (wall, floor, ceiling, free‑standing or mounted) hoists, and body‑support units. The standard addresses both general and product‑specific safety, performance and information requirements and includes Annexes A–C with general recommendations.
This standard:
- Replaces EN ISO 10535:2006 and is ISO 10535:2021 adopted as a European standard.
- Excludes devices that transport persons between building levels (elevators) and does not include ageing/corrosion testing or pre‑use qualification of individual units.
Key technical topics and requirements
The standard defines test methods and performance criteria across multiple areas without prescribing specific numeric values in this summary. Major technical topics include:
- Risk management and ergonomics for both the person being hoisted and the attendant.
- General safety: prevention of traps, safety of moving/folding parts, V‑shaped opening hazards, noise and vibration.
- Structural and mechanical tests: static strength, static stability and durability tests for mobile and stationary hoists.
- Performance tests: rate of lifting/lowering, powered horizontal movement, and spreader bar/central suspension point integrity.
- Operating forces/torques and moving forces requirements to ensure usability by attendants.
- Immobilizing devices (brakes) test methods for mobile hoists.
- Hydraulic and pneumatic components: dedicated requirements and test methods.
- Machine‑washable hoists: specific requirements and tests for hygiene.
- Information and labelling: pre‑sale information, instructions for use and marking requirements to support safe operation.
Practical applications and users
Who uses ISO 10535:
- Manufacturers and product designers to design compliant hoists and body‑support units.
- Test laboratories and conformity assessors to perform standardized performance and safety tests.
- Procurement teams, healthcare facilities and care homes selecting safe transfer equipment.
- Regulators and standards committees for certification, surveillance and policy development.
- Service technicians and attendants for understanding maintenance, safe use and limits of equipment.
Practical benefits:
- Improved safety of person transfers and reduced injury risk for users and carers.
- Clear, repeatable test methods to demonstrate product performance and reliability.
- Standardized information for safe selection, installation and use.
Related standards and references
- ISO 9999 - classification of assistive products (referenced for product categories).
- EN ISO 10535:2006 - superseded by this edition.
- Prepared by ISO/TC 173 (Assistive products) in collaboration with CEN/TC 293.
Keywords: hoists for the transfer of persons, assistive products, ISO 10535, mobile hoists, stationary hoists, body‑support units, safety, performance, test methods.
Frequently Asked Questions
EN ISO 10535:2021 is a standard published by the European Committee for Standardization (CEN). Its full title is "Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021, Corrected version 2023-08)". This standard covers: This document specifies requirements and test methods for hoists and body-support units intended for the transfer of persons with disabilities. The document applies to the following products classified in ISO 9999:—[1]. — 12 36 03 Mobile hoists for transferring a person in sitting position with sling seats; — 12 36 04 Mobile hoists for transferring a person in standing position; — 12 36 06 Mobile hoists for transferring a person in sitting position with solid seats; — 12 36 09 Mobile hoists for transferring a person in lying position; — 12 36 12 Stationary hoists fixed to walls, floor or ceiling; — 12 36 15 Stationary hoists fixed to, or mounted in or on, another product; — 12 36 18 Stationary free-standing hoists; — 12 36 21 Body-support units for hoists. This document covers different types of mobile and stationary hoists. Some of the requirements and test methods are general and others are only valid for specific product types. Annexes A, B and C provide general recommendations. This document 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. It does not include methods to qualify individual units prior to use. The requirements of this document are formulated with regard to the needs of both the persons being hoisted and the attendant using the hoist. [1] Under preparation. Stage at the time of publication: ISO/FDIS 9999:2021.
This document specifies requirements and test methods for hoists and body-support units intended for the transfer of persons with disabilities. The document applies to the following products classified in ISO 9999:—[1]. — 12 36 03 Mobile hoists for transferring a person in sitting position with sling seats; — 12 36 04 Mobile hoists for transferring a person in standing position; — 12 36 06 Mobile hoists for transferring a person in sitting position with solid seats; — 12 36 09 Mobile hoists for transferring a person in lying position; — 12 36 12 Stationary hoists fixed to walls, floor or ceiling; — 12 36 15 Stationary hoists fixed to, or mounted in or on, another product; — 12 36 18 Stationary free-standing hoists; — 12 36 21 Body-support units for hoists. This document covers different types of mobile and stationary hoists. Some of the requirements and test methods are general and others are only valid for specific product types. Annexes A, B and C provide general recommendations. This document 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. It does not include methods to qualify individual units prior to use. The requirements of this document are formulated with regard to the needs of both the persons being hoisted and the attendant using the hoist. [1] Under preparation. Stage at the time of publication: ISO/FDIS 9999:2021.
EN ISO 10535:2021 is classified under the following ICS (International Classification for Standards) categories: 11.180.10 - Aids and adaptation for moving. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 10535:2021 has the following relationships with other standards: It is inter standard links to EN ISO 10535:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 10535:2021 is associated with the following European legislation: EU Directives/Regulations: 92/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 10535:2021 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2022
Nadomešča:
SIST EN ISO 10535:2007
Tehnični pripomočki - Dvigala za prestavljanje oseb - Zahteve in preskusne
metode (ISO 10535:2021)
Assistive products - Hoists for the transfer of persons - Requirements and test methods
(ISO 10535:2021)
Lifter zum Transfer von Menschen mit Behinderungen - Anforderungen und
Prüfverfahren (ISO 10535:2021)
Produits d'assistance - Lève-personnes pour transférer des personnes - Exigences et
méthodes d'essais (ISO 10535:2021)
Ta slovenski standard je istoveten z: EN ISO 10535:2021
ICS:
11.180.10 Pripomočki in prilagoditve za Aids and adaptation for
gibanje moving
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 10535
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2021
EUROPÄISCHE NORM
ICS 11.180.10 Supersedes EN ISO 10535:2006
English Version
Assistive products - Hoists for the transfer of persons -
Requirements and test methods (ISO 10535:2021)
Produits d'assistance - Lève-personnes pour transférer Lifter zum Transfer von Menschen mit Behinderungen
des personnes - Exigences et méthodes d'essais (ISO - Anforderungen und Prüfverfahren (ISO 10535:2021)
10535:2021)
This European Standard was approved by CEN on 31 August 2021.
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 standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10535:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10535:2021) has been prepared by Technical Committee ISO/TC 173 "Assistive
products" in collaboration with Technical Committee CEN/TC 293 “Assistive products and accessibility”
the secretariat of which is held by SIS.
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 May 2022, and conflicting national standards shall be
withdrawn at the latest by May 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10535:2006.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10535:2021 has been approved by CEN as EN ISO 10535:2021 without any modification.
INTERNATIONAL ISO
STANDARD 10535
Third edition
2021-10
Assistive products — Hoists for the
transfer of persons — Requirements
and test methods
Produits d'assistance — Lève-personnes pour transférer des
personnes — Exigences et méthodes d'essais
Reference number
ISO 10535:2021(E)
ISO 10535:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10535:2021(E)
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements and test methods . 8
4.1 General requirements . 8
4.1.1 Risk management . 8
4.1.2 Ergonomic factors . 8
4.1.3 Noise and vibration . 8
4.1.4 Safety of moving and folding parts . 9
4.1.5 Prevention of traps for parts of the human body . 10
4.1.6 V-shaped openings . 11
4.2 General test methods . 11
4.2.1 Test conditions . 11
4.2.2 Apparatus . 11
4.2.3 Permissible errors of test equipment .12
4.2.4 Test report .12
4.2.5 Safety and performance requirements . 16
4.2.6 Test methods for general safety requirements . 19
4.3 Requirements for body-support units . 22
4.4 Central suspension point .22
4.4.1 Requirements for central suspension point . 22
4.4.2 Test method for the central suspension point .22
4.5 Spreader bar .22
4.5.1 Requirements for spreader bar . 22
4.5.2 Test methods for the spreader bar . 23
4.6 Performance . 23
4.6.1 Requirements for performance . 23
4.6.2 Test methods for performance . 23
4.7 Rate of movements of the hoist . 24
4.7.1 Requirements for rate of lifting and lowering . 24
4.7.2 Test methods for rate of lifting and lowering . 24
4.7.3 Requirements for rate of powered horizontal movement . 24
4.7.4 Test methods for rate of powered horizontal movement . 24
4.8 Operating forces/torques . 24
4.8.1 Requirements for operating forces/torques . . 24
4.8.2 Test methods for operating forces/torques . 25
4.9 Durability . 25
4.9.1 Requirements for durability . 25
4.9.2 Test methods for durability . 25
4.10 Hydraulic components . 27
4.10.1 Requirements for hydraulic components . 27
4.10.2 Test methods for hydraulic components .28
4.11 Pneumatic components .28
4.11.1 Requirements for pneumatic components .28
4.11.2 Test methods for pneumatic components .28
4.12 Machine washable hoists . 29
4.12.1 Requirements for machine washable hoists .29
4.12.2 Test methods for machine washable hoists . .29
4.13 Requirement for information supplied by the manufacturer .30
4.13.1 General .30
4.13.2 Instructions for use. 30
iii
ISO 10535:2021(E)
4.13.3 Labelling . 32
5 Mobile hoists — Specific requirements and test methods .37
5.1 General requirements . 37
5.2 Static strength . . 37
5.2.1 Requirements for static strength . 37
5.2.2 Test methods for static strength . 37
5.3 Static stability .38
5.3.1 Requirements for static stability .38
5.3.2 Test methods for static stability .38
5.4 Immobilizing device (brakes) .38
5.4.1 Requirements for immobilizing device (brakes) .38
5.4.2 Test methods for immobilizing device (brakes) .38
5.5 Moving forces . .39
5.5.1 Requirements for moving forces .39
5.5.2 Test methods for moving forces.39
5.6 Requirement for information supplied by the manufacturer .40
5.6.1 Pre-sale information .40
6 Mobile hoists for transferring a person in standing position— Specific requirements
and test methods.41
6.1 General requirements . 41
6.2 Static strength . . 41
6.2.1 Requirements for static strength . 41
6.2.2 Test method for static strength. 41
6.3 Static stability . 41
6.3.1 Requirements for static stability . 41
6.3.2 Test methods for static stability . 42
6.4 Immobilizing device (brakes) . 43
6.4.1 Requirements for immobilizing device (brakes) . 43
6.4.2 Test methods for immobilizing device (brakes) . 43
6.5 Moving forces . . 43
6.5.1 Requirements for moving forces . 43
6.5.2 Test methods for moving forces. 43
6.6 Durability . 43
6.6.1 Requirements for durability . 43
6.6.2 Test methods for durability . 43
6.7 Requirement for information supplied by the manufacturer .44
6.7.1 Pre-sale information .44
7 Stationary hoists — Specific requirements and test methods . 44
7.1 General requirements .44
7.2 Specific safety requirements . 45
7.2.1 Requirements for specific safety requirements . 45
7.2.2 Test methods for specific safety requirements . 45
7.3 Static strength (free-standing stationary hoists only) . 45
7.3.1 Requirements for static strength (free-standing stationary hoists only) . 45
7.3.2 Test methods for static strength (free-standing stationary hoists only) . 45
7.4 Static stability (free-standing stationary hoists only) .46
7.4.1 Requirements for static stability (free-standing stationary hoists only) .46
7.4.2 Test methods for static stability (free-standing stationary hoists only) .46
7.5 Static strength for all other stationary hoists . 47
7.5.1 Requirements for static strength for all other stationary hoists . 47
7.5.2 Test methods for static strength for all other stationary hoists . 47
7.6 Requirement for information supplied by the manufacturer . 47
7.6.1 User information . 47
8 Non-rigid body-support units — Specific requirements and test methods .47
8.1 General requirements . 47
8.2 Requirements for material and seams of the non-rigid body-support unit . 47
iv
ISO 10535:2021(E)
8.3 Test methods for non-rigid body-support unit .48
8.3.1 Test methods for non-rigid body-support unit designed to be laundered .48
8.3.2 Test method for durability for non-rigid body-support unit .48
8.4 Requirement for information supplied by the manufacturer .48
8.4.1 Pre-sale information .48
8.4.2 User information .48
8.4.3 Labelling .49
9 Rigid body-support units — Specific requirements and test methods .49
9.1 General requirements .49
9.2 Requirements for backrest .50
9.3 Requirements and test methods for durability .50
9.4 Requirement for information supplied by the manufacturer .50
9.4.1 User information .50
9.4.2 Labelling . 50
10 Bathtub hoists — Specific requirements and test methods .51
10.1 General requirements . 51
10.1.1 General . 51
10.1.2 Risk analysis . 51
10.1.3 Ergonomic factors . 51
10.1.4 Noise . 51
10.1.5 Safety of moving and folding parts . 51
10.1.6 Prevention of traps for parts of the human body . 51
10.1.7 V-shaped openings . 51
10.2 General test methods . 52
10.2.1 Test conditions . 52
10.2.2 Test equipment . 52
10.2.3 Permissible errors of test equipment . 52
10.2.4 Test report . 52
10.3 Safety requirements . 52
10.3.1 General safety requirements . 52
10.3.2 Test methods for general safety requirements . 52
10.4 Body-support units . 53
10.5 Spreader bar .53
10.6 Performance .53
10.7 Rate of movements of the hoist . 53
10.8 Operating forces/torques .53
10.9 Durability . 53
10.9.1 Requirements for durability . 53
10.9.2 Test methods for durability . 53
10.10 Static strength and stability .54
10.10.1 Requirements for static strength and stability .54
10.10.2 .
Test methods for static strength and stability .54
10.11 Hydraulic components .54
10.12 Pneumatic components . 55
10.13 Specific safety requirements . 55
10.13.1 Requirements for specific safety requirements . 55
10.13.2 .
Test methods for specific safety requirements . . 55
10.14 Non-rigid body-support units .55
10.15 Rigid body-support units — Requirements . 55
10.16 Requirement for information supplied by the manufacturer . 55
10.16.1 General .55
10.16.2 .
Instructions for use.55
10.16.3 .
Labelling . 55
v
ISO 10535:2021(E)
Annex A (informative) Rationale for specific safety requirements .56
Annex B (informative) Periodic inspection and maintenance .58
Annex C (informative) Compatibility of hoist/spreader bar/body-support units .61
Annex D (informative) Guidelines for colour coding for size of non-rigid body-support units .74
Bibliography .75
vi
ISO 10535:2021(E)
Foreword
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 173, Assistive products, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive
products and accessibility, in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 10535:2006), which has been technically
revised.
The main changes are as follows:
— aspects on hoists with robotic features has been included;
— guidelines regarding compatibility of hoists/body-support units have been included;
— the informative annex on Inspection has been further developed;
— lowering of minimum capacity of a mobile hoist from 120 kg to 100 kg;
— requirement of emergency lowering device for mobile hoist and standing/raising hoists has been
included.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vii
ISO 10535:2021(E)
Introduction
It appears from studies that the nursing and caring profession involves many physically burdening
factors in the caring for and nursing of persons with disabilities. A hoist offers a safe means of
supportive lifting and moving, either assisted or independently.
This document specifies requirements and test methods that are relevant to hoists for the transfer of
persons with disabilities. This document addresses further needs in terms of providing safety for both
the person with a disability and the attendant, while taking into account the potential new development
within robotic technology on hoist solutions.
viii
INTERNATIONAL STANDARD ISO 10535:2021(E)
Assistive products — Hoists for the transfer of persons —
Requirements and test methods
1 Scope
This document specifies requirements and test methods for hoists and body-support units intended for
the transfer of persons with disabilities. The document applies to the following products classified in
1)
ISO 9999:— .
— 12 36 03 Mobile hoists for transferring a person in sitting position with sling seats;
— 12 36 04 Mobile hoists for transferring a person in standing position;
— 12 36 06 Mobile hoists for transferring a person in sitting position with solid seats;
— 12 36 09 Mobile hoists for transferring a person in lying position;
— 12 36 12 Stationary hoists fixed to walls, floor or ceiling;
— 12 36 15 Stationary hoists fixed to, or mounted in or on, another product;
— 12 36 18 Stationary free-standing hoists;
— 12 36 21 Body-support units for hoists.
This document covers different types of mobile and stationary hoists. Some of the requirements and
test methods are general and others are only valid for specific product types.
Annexes A, B and C provide general recommendations.
This document 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.
It does not include methods to qualify individual units prior to use.
The requirements of this document are formulated with regard to the needs of both the persons being
hoisted and the attendant using the hoist.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14971, Medical devices — Application of risk management to medical devices
1) Under preparation. Stage at the time of publication: ISO/FDIS 9999:2021.
ISO 10535:2021(E)
ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the
manufacturer — Part 1: General requirements
ISO 20417, Medical devices — Information to be supplied by the manufacturer
IEC 60204-1, Safety of machinery - Electrical equipment of machines - Part 1: General requirements
IEC 60529, Degrees of protection provided by enclosures (IP Code)
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements
for basic safety and essential performance
IEC 60601-1-2:2014+AMD1: 2020, Medical electrical equipment — Part 1-2: General requirements for
safety — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-11, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance - Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications
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 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 13480-3:2017, Metallic industrial piping — Part 3: Design and calculation
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
adverse condition
condition in which failure is most likely to occur
3.2
attendant
person who operates the hoist if not the person with disability (3.36)
3.3
backrest
part of the body-support unit (3.6) that provides support to the back of the person being lifted in a hoist
3.4
backwards
180° to the forwards (3.20) direction of travel
ISO 10535:2021(E)
3.5
bathtub hoist
equipment specifically designed to be used in or adjacent to a bathtub for transferring by lifting and
moving a person in an area limited by the system
3.6
body-support unit
device for providing support to a person being lifted, transferred or moved in a hoist, with its associated
attachment structure
EXAMPLE A sling, seat or stretcher.
3.7
ceiling hoist
equipment for transferring by lifting and moving a person in a specific location by an overhead mounted
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 1 to entry: This point may be a connecting point.
3.9
connecting point
part to which the body-support unit (3.6) attaches
3.10
control device
part or parts of the hoist that operate the lifting and lowering
...
EN ISO 10535:2021 표준 문서는 장애인을 위한 인양 장치 및 지지장치에 대한 요건과 시험 방법을 구체적으로 정의하고 있습니다. 이 표준은 다양한 유형의 이동형 및 고정형 호이스트를 포괄하는데, 특히 다음과 같은 제품에 적용됩니다: 슬링 좌석이 장착된 앉은 자세의 이동형 호이스트, 서 있는 자세의 이동형 호이스트, 단단한 좌석으로 옮기는 앉은 자세의 이동형 호이스트, 누운 자세의 이동형 호이스트, 벽이나 바닥, 천장에 고정된 고정형 호이스트 등입니다. 이 표준의 강점 중 하나는 다양한 호이스트 유형에 대한 요구사항과 시험 방법을 명확하게 구분하여 정의하고 있다는 점입니다. 일반적인 요구사항 외에도 특정 제품 유형에만 유효한 별도의 규정이 마련되어 있어 사용자가 필요로 하는 다양한 상황에 적합하게 설계되었습니다. 부록 A, B 및 C에서는 일반적인 권장 사항을 제공하여 호이스트 사용자와 보조인의 요구를 동시에 충족시키는 데 기여하고 있습니다. EN ISO 10535:2021은 단순히 제품의 안전성을 보장하는 데 그치지 않으며, 장애인을 돕는 보조기구의 사용을 더욱 용이하게 만들어 주는 점에서 매우 중요합니다. 또한, 이 문서는 건물 내 두 개의 층 간의 이동을 위한 장치에는 적용되지 않으며, 이러한 호이스트의 노화나 부식에 대한 평가 방법을 포함하고 있지 않다는 점을 유념해야 합니다. 결론적으로, EN ISO 10535:2021 표준은 장애인을 위한 호이스트와 관련된 요구 사항을 체계적으로 정리한 문서로, 품질과 안전성을 확보하며 사용자와 보조인 모두의 필요를 충족시키기 위한 중요한 기준을 제시하고 있습니다.
EN ISO 10535:2021は、障害者の移動支援を目的としたリフト及び体支援装置に関する要求事項と試験方法を定めた重要な標準です。この文書は、ISO 9999に分類されるさまざまな移動型及び固定型リフトに適用されます。具体的には、座位での移動、立位での移動、横たわった状態での移動等、異なる状況における利用を考慮しています。 この標準の強みは、利用者や介護者のニーズを考慮して要求事項が策定されている点です。これは、製品が適切かつ安全に機能し、様々なユーザーの状況に応じた柔軟性を提供することを意味します。また、一般的な試験方法に加え、特定の製品タイプに特化した要求事項が設けられていることも、実用性と安全性の向上につながります。 附属書A、B、Cでは一般的な推奨事項が提供されており、これにより使用者は選択肢を持ち、効果的な運用が可能になります。この標準は、明確に移動支援のリフトに焦点を合わせているため、施設における利用者の移動効率を高めることが期待されます。 しかしながら、この文書は建物の異なる階層間での運搬装置には適用されず、リフトや装置の老朽化や腐食の評価方法、使用前の個別ユニットの適合性を確認するための方法は含まれていない点に留意が必要です。従って、これらの要件を検討する際には、追加の基準や評価が必要となるでしょう。
La norme EN ISO 10535:2021 est un document fondamental qui établit les exigences et les méthodes d'essai pour les dispositifs de levage destinés au transfert de personnes en situation de handicap. Elle s'applique à une large gamme de produits, notamment les élévateurs mobiles et fixes, qui sont classés selon la norme ISO 9999. Cette diversification dans le champ d'application permet de répondre efficacement à différents besoins en matière de transfert, qu’il s’agisse de personnes en position assise, debout ou allongée. L'une des forces majeures de cette norme réside dans son approche globale qui tient compte des besoins à la fois des utilisateurs et des aides-soignants. Les exigences formulées garantissent non seulement la sécurité des personnes transférées, mais également un maniement simplifié pour les aides-soignants, contribuant ainsi à améliorer la qualité des soins. Les méthodes d'essai précises proposées pour chaque type de produit permettent de s'assurer que les élévateurs répondent aux normes de sécurité et de performance élevées. Les annexes A, B et C enrichissent le document en offrant des recommandations générales qui sont essentielles pour la mise en œuvre des dispositifs. Bien que la norme ne couvre pas les dispositifs de transport entre différents niveaux d'un bâtiment ni les méthodes pour évaluer le vieillissement ou la corrosion, son focus sur les exigences spécifiques aux dispositifs de levage des personnes permet de maintenir un niveau de spécialisation élevé. La pertinence de la norme EN ISO 10535:2021 dans le contexte actuel ne peut être sous-estimée. Avec le vieillissement de la population et l'augmentation des besoins en assistance, cette norme constitue un outil clé pour assurer la sécurité et le bien-être des personnes ayant des besoins spécifiques. En définissant des exigences adaptées et des méthodes d'essai claires pour les élévateurs et les unités de soutien corporel, la norme contribue à la standardisation et à l'amélioration continue des dispositifs d'assistance à la mobilité.
The EN ISO 10535:2021 standard provides a comprehensive framework for the requirements and test methods needed for assistive products, specifically hoists for transferring persons with disabilities. This standard is crucial for ensuring safety, efficacy, and user comfort during such transfers, which is essential in enhancing the quality of care and promoting independence for individuals with mobility challenges. The scope of this standard is well-defined, focusing on various types of hoists, including mobile hoists designed for different transfer positions-sitting, standing, and lying-as well as stationary hoists that can be fixed or freestanding. This broad classification under ISO 9999 ensures that the standard addresses a range of products that fall under specific categories of assistive devices, thereby enhancing its applicability across different scenarios. One of the significant strengths of EN ISO 10535:2021 is its detailed specification of requirements and test methods, tailored to each type of hoist, thus ensuring that they meet high safety and operational standards. The inclusion of both general and specific requirements provides manufacturers with a clear guideline for product development and testing, ensuring that the assistive products are safe and reliable for users and attendants alike. Additionally, the standard's structure, bolstered by the annexes (A, B, and C) that offer general recommendations, enhances its usability for manufacturers looking to adhere to best practices in their production processes. This guidance is particularly valuable in fostering innovation in assistive technologies while maintaining a focus on user safety and comfort. While the standard effectively addresses the needs of those who will utilize these devices, it acknowledges its limitations by specifying that it does not encompass methods for the determination of aging or corrosion in hoists, nor does it include methods for qualifying individual units before use. This delineation of scope is essential for ensuring that manufacturers and users understand the boundaries of the document's applicability. Overall, the EN ISO 10535:2021 standard is a critical document for stakeholders in the assistive technology sector, ensuring that hoists for the transfer of persons are designed and tested to meet the safety and comfort needs of users and caregivers alike. Its comprehensive nature and focus on practical requirements and test methods highlight its relevance and importance in the field of assistive products.
Die Norm EN ISO 10535:2021 bietet eine umfassende Regelung für Hebevorrichtungen und Körperstützeinheiten, die für den Transfer von Personen mit Behinderungen bestimmt sind. Sie definiert klare Anforderungen und Prüfmethoden für mobile und stationäre Hebesysteme, die in verschiedenen Anwendungsszenarien zum Einsatz kommen. Die Norm umfasst sowohl mobile Hebevorrichtungen, die Personen in sitzender oder stehender Position transferieren, als auch stationäre Systeme, die an Wänden, Böden oder Decken befestigt sind. Eine der Stärken dieser Norm ist ihre Differenziertheit. Sie berücksichtigt die spezifischen Anforderungen verschiedener Produkttypen, wie z.B. mobile Hebesysteme mit Sling-Sitzen oder feste Sitze. Diese Anpassungsfähigkeit an unterschiedliche Produkte macht die Norm besonders relevant für Hersteller und Anwender, die sicherstellen möchten, dass ihre Produkte den internationalen Standards entsprechen. Die Norm enthält auch allgemeine Empfehlungen in den Anhängen A, B und C, die zusätzliche Richtlinien zur sicheren Nutzung und zur Vermeidung von Unfällen geben. Besonders hervorzuheben ist, dass die Anforderungen auf die Bedürfnisse sowohl der zu hebenden Personen als auch der Begleitpersonen ausgerichtet sind, was die Sicherheit und Effizienz im Transferprozess erhöht. Zu beachten ist, dass die Norm nicht für Geräte gilt, die Personen zwischen verschiedenen Ebenen eines Gebäudes transportieren. Auch Methoden zur Bestimmung von Alterung oder Korrosion der Hebesysteme sind nicht enthalten, ebenso wenig wie Verfahren zur Qualifizierung einzelner Einheiten vor ihrer Nutzung. Dieses klare Abgrenzung ermöglicht es Herstellern, sich auf die wesentlichen Sicherheitsanforderungen und Testmethoden zu konzentrieren. Insgesamt leistet die EN ISO 10535:2021 einen wichtigen Beitrag zur Schaffung von sicheren und effektiven Transfersystemen für Menschen mit Behinderungen. Sie bietet sowohl eine solide Grundlage für Hersteller als auch wichtige Informationen für Fachkräfte im Gesundheitswesen, die im Umgang mit solchen Assistenzprodukten tätig sind.
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