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11.180.10 - Aids and adaptation for moving

ICS 11.180.10 Details

Aids and adaptation for moving

Hilfsmittel zur Fortbewegung. Prothesen. Orthesen

Aides a la marche

Pripomočki in prilagoditve za gibanje

General Information

Parent
11.180 - Aids for disabled or handicapped persons

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Standardization Organization
Technical Committee
Directive
Mandate
50
ISO
ISO 16840-2:2018/Amd 1:2024(Amendment)
Wheelchair seating — Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity — Amendment 1: Updates and addition of new Annex covering alternatively sized cushions
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ISO
ISO 16840-10:2021/Amd 1:2024(Amendment)
Wheelchair seating — Part 10: Resistance to ignition of postural support devices — Requirements and test method — Amendment 1: Amended with additional Annexes and test method
  • Standard
    19 pages
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ISO
ISO/TS 16840-15:2024(Main)
Wheelchair seating — Part 15: Selection, placement and fixation of flexible postural support devices in seating

This document specifies requirements for the selection, placement and fixation of flexible postural support devices within seating devices and systems and to chairs, including wheelchairs and bathroom equipment. Seating devices can be involved in one or more situations, including hoists, static seating, wheelchair seating, shower chairs, etc. The devices enable the seated person (the occupant) to be positioned to maximize their functional activities in a safe environment. These requirements are formulated to achieve a balance of posture maintenance and safety. This document covers flexible positioning supports (padded or otherwise) used for postural positioning and/or safety. It does not cover belts and harnesses used in transportation for restraint, postural support devices made from rigid materials such as metal, wood, or hard plastics, or postural support devices designed solely for use in sports-related seating.

  • Technical specification
    51 pages
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IEC
ISO 5363:2024(Main)
Robotics - Test methods for exoskeleton-type walking RACA robot

This document specifies test methods for the exoskeleton-type walking RACA robot used as medical electrical equipment which is intended to move from one location to another, by making reciprocating motion having intermittent contact with the travel surface.
This document does not apply to passive or non-powered exoskeletons.
NOTE These tests can be used to verify conformity with the requirements of IEC 80601-2-78.

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ISO
ISO 5363:2024(Main)
Robotics — Test methods for exoskeleton-type walking RACA robot

This document specifies test methods for the exoskeleton-type walking RACA robot used as medical electrical equipment which is intended to move from one location to another, by making reciprocating motion having intermittent contact with the travel surface. This document does not apply to passive or non-powered exoskeletons. NOTE These tests can be used to verify conformity with the requirements of IEC 80601-2-78.

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ISO
ISO/TS 16840-14:2023(Main)
Wheelchair seating — Part 14: Concepts related to managing external forces to maintain tissue integrity

This document describes common terms related to forces and their effects as experienced by human bodies and their support surfaces. It provides further information on concepts around how these forces affect the human body's response to postural support systems, and particularly highlights the impact of the interface between tissues and postural support devices (PSD) on the maintenance of tissue integrity. It provides a general introduction to biomechanical concepts, phenomena, and vocabulary. This is intended to facilitate effective understanding and sharing of information between a range of disciplines/stakeholders involved in providing equipment to manage tissue integrity. Representative stakeholders include people with a disability, occupational therapists, physical therapists, biomedical engineers, nurses, medical and para medical personnel, device manufacturers, and other professionals facilitating development, provision, and access to seating and mobility equipment. This document does not provide detailed information that is currently available in physiological text books or scientific literature.

  • Technical specification
    12 pages
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ISO
ISO 7176-31:2023(Main)
Wheelchairs — Part 31: Lithium-ion battery systems and chargers for powered wheelchairs — Requirements and test methods

This document specifies requirements and test methods for lithium-ion batteries and battery systems intended for use in electrically powered wheelchairs, and their charging systems.

  • Standard
    10 pages
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SIST
SIST EN 12183:2022(Main)
Manual wheelchairs - Requirements and test methods
EN 12183:2022

This document specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 250 kg, including:
—   stand-up manual wheelchairs, and
—   manual wheelchairs for showering and/or toileting.
This document does not apply to custom-made manual wheelchairs or manual wheelchairs intended for use in sports.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

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SIST
SIST EN 12184:2022(Main)
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
EN 12184:2022

TThis document specifies requirements and test methods for electrically powered wheelchairs, with a maximum speed not exceeding 20 km/h, intended to carry one person of mass not greater than 300 kg, including:
-   electrically powered scooters with three or more wheels,
-   manual wheelchairs with an add-on drive system,
-   handrim-activated power-assisted wheelchairs,
-   electrically powered stand-up wheelchairs,
-   balancing wheelchairs,
-   wheelchairs with a pivot drive wheel unit, and
-   assistant-guided wheelchairs.
This document does not apply to custom-made electrically powered wheelchairs or electrically powered wheelchairs intended for use in sports.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

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ISO
ISO 16840-3:2022(Main)
Wheelchair seating — Part 3: Determination of static, impact, and repetitive load strengths for postural support devices

This document specifies requirements for static, impact, and repetitive load strengths for postural support devices (PSDs) with associated attachment hardware intended for use with an undefined wheelchair seating system. It specifies the test methods for determining whether the minimum performance requirements have been met to release a product into use. It also specifies requirements for disclosure of the test results. Not all tests apply to all PSDs. This document is also applicable to other seating systems. The test methods can be used to verify the manufacturer’s claims that a product meets the requirements of this document. This document does not apply to PSDs that are designed to fail under certain static, dynamic, or repetitive loads. This document does not apply to the strength of PSDs under crash conditions in a motor vehicle. This document does not evaluate long-term useful life. NOTE 1 ISO 16840‑4 provides crash test methods and requirements for wheelchair seating systems when used as part of a wheelchair seat in a motor vehicle. NOTE 2 For user masses greater or less than those specified in this document, appropriate extrapolation of test apparatus dimensions, mounting point separation, forces, etc. can be carried out, and the test parameters noted in the test report. NOTE 3 Rigid surrogate test fixtures are utilized to provide a standardized test method, and consequently this document does not involve a test of a PSD on a particular wheelchair.

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ISO
ISO 7176-25:2022(Main)
Wheelchairs — Part 25: Lead-acid batteries and chargers for powered wheelchairs — Requirements and test methods

This document specifies requirements and test methods for lead-acid batteries and their chargers intended for use with electrically-powered wheelchairs and scooters. Requirements for chargers are applicable to those with a rated input voltage not greater than 250 V AC and a nominal output voltage not greater than 36 V.

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CEN
EN 81-40:2020(Main)
Safety rules for the construction and installation of lifts - Special lifts for the transport of persons and goods - Part 40: Stairlifts and inclined lifting platforms intended for persons with impaired mobility
SIST EN 81-40:2020

1.1   This document deals with safety requirements for construction, manufacturing, installation, maintenance and dismantling of electrically operated stairlifts (chair, standing platform and wheelchair platform) affixed to a building structure, moving in an inclined plane and intended for use by persons with impaired mobility:
-   travelling over a stair or an accessible inclined surface;
-   intended for use by one person;
-   whose carriage is directly retained and guided by a guide rail or rails;
-   supported or sustained by rope (5.4.4), rack and pinion (5.4.5), chain (5.4.6), friction traction drive (5.4.7), and guided rope and ball (5.4.8).
1.2   This document identifies hazards as listed in Clause 4 which arise during the various phases in the life of such equipment and describes methods for the elimination or reduction of these hazards when used as intended by the manufacturer.
1.3   This document does not specify the additional requirements for:
-   operation in severe conditions (e.g. extreme climates, strong magnetic fields);
-   operation subject to special rules (e.g. potentially explosive atmospheres);
-   handling of materials, the nature of which could lead to dangerous situations;
-   use of energy systems other than electricity;
-   hazards occurring during manufacture;
-   earthquakes, flooding, fire;
-   evacuation during a fire;
-   stairlifts for goods only;
-   concrete, hardcore, timber or other foundation or building arrangement;
-   design of anchorage bolts to the supporting structure.
NOTE   For the actual type of machinery, noise is not considered a significant nor relevant hazard.
1.4   This document is not applicable to power operated stairlifts which are manufactured before the date of publication of this document by CEN.

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CEN
EN 12183:2022(Main)
Manual wheelchairs - Requirements and test methods
SIST EN 12183:2022

This document specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not less than 25 kg and not greater than 250 kg, including
- stand-up manual wheelchairs, and
- manual wheelchairs whose intended use includes showering and/or toileting.
This document does not apply to custom-made manual wheelchairs, manual wheelchairs intended for use in sports, or manual wheelchairs intended only for showering and/or toileting.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

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CEN
EN 12184:2022(Main)
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
SIST EN 12184:2022

This document specifies requirements and test methods for electrically powered wheelchairs, with a maximum speed not exceeding 20 km/h, intended to carry one person of mass not less than 25 kg and not greater than 300 kg, including
- electrically powered scooters with three or more wheels,
- manual wheelchairs with an add-on electrically powered drive system,
- handrim-activated power-assisted wheelchairs,
- electrically powered stand-up wheelchairs,
- wheelchairs with a pivot drive wheel unit, and
- push-assist wheelchairs.
This document does not apply to balancing wheelchairs, custom-made electrically powered wheelchairs or electrically powered wheelchairs intended for use in sports.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

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CEN
EN ISO 10535:2021(Main)
Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021, Corrected version 2023-08)
SIST EN ISO 10535:2022

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.

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ISO
ISO 16840-11:2022(Main)
Wheelchair seating — Part 11: Determination of dissipation characteristics of sensible perspiration into seat cushions

This document specifies a method for determining the dissipation characteristics of simulated sensible perspiration exposure on seat cushions of a wheelchair under test conditions that simulate body loading on support surfaces with flat and contoured profiles. The test method is applicable to a wide variety of seat cushion materials and constructions that are used across the world. The test method is intended to determine how the cushion handles a liquid load. It is not intended to determine how the cushion responds to a continuous release of liquid or vapour. This document also specifies apparatus to measure dissipation characteristics (of perspiration) of seat cushions and the approach to be employed in measuring these characteristics. This document is applicable to seat cushions for wheelchairs that include a cushion cover. NOTE The significance of the dissipation characteristics of the seat cushion can be greatly affected by the clothing worn, for example a moisture wicking cover might not help the skin condition of the patient sitting in a wet adult diaper.

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ISO
ISO 7176-32:2022(Main)
Wheelchairs — Part 32: Test method for wheelchair castor assembly durability

This document specifies strength requirements and test methods for wheelchair castor assemblies. The test methods include corrosion, abrasion and fatigue conditions. This document also specifies requirements for disclosure of test results. It is applicable to castor assemblies of or developed for use in occupant and to assistant-propelled manual wheelchairs and electrically powered wheelchairs. The test requirements are also applicable to wheelchair castor assemblies not necessarily associated or supplied with a wheelchair. Castor assemblies including those with anti-tip castor wheels that do not touch the ground during wheelchair travel are outside the scope of this document.

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ISO
ISO 7176-19:2022(Main)
Wheelchairs — Part 19: Wheelchairs for use as seats in motor vehicles

This document specifies test methods, requirements and recommendations for wheelchairs intended for use as seats in motor vehicles related to design, performance, labelling, presale literature, user instructions and user warnings. This document is applicable to all manual and powered wheelchairs, including scooters, which, in addition to their primary function as wheeled mobility devices, are also likely to be used as forward-facing seats in motor vehicles by children and adults with a body mass equal to or greater than 12 kg. This document is applicable to complete wheelchairs, including a frame or powerbase and seating system. It is also applicable to wheelchairs equipped with additional components designed to facilitate conformity with one or more of the requirements of this document.

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ISO
ISO 7176-14:2022(Main)
Wheelchairs — Part 14: Power and control systems for electrically powered wheelchairs and scooters — Requirements and test methods

This document specifies requirements and associated test methods for the power, and control systems of electrically powered wheelchairs and scooters. It sets safety and performance requirements that apply during normal use and some conditions of abuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and sets limits on the forces needed for some operations. This document is applicable to electrically powered wheelchairs and scooters with a maximum speed no greater than 15 km/h intended to provide indoor and/or outdoor mobility for one disabled person whose mass lies in the range specified in ISO 7176-11.

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CEN
EN ISO 11199-2:2021(Main)
Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2021)
SIST EN ISO 11199-2:2021

This document specifies requirements and test methods of rollators being used as assistive products for walking with wheels, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer including marking and labelling.
The requirements and tests are based on every-day use of rollators as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes rollators specified for a user mass of no less than 35 kg.
This document is not applicable to rollators with horizontal forearm supports, classified as walking tables, for which ISO 11199-3 is applicable.

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CEN
EN ISO 11199-1:2021(Main)
Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1:2021)
SIST EN ISO 11199-1:2021

This document specifies requirements and test methods for walking frames used as assistive products for walking, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling.
The requirements and tests are based on everyday use of walking frames as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes walking frames specified for a user mass of no less than 35 kg.

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SIST
SIST EN ISO 10535:2022(Main)
Assistive products - Hoists for the transfer of persons - Requirements and test methods (ISO 10535:2021)
EN ISO 10535:2021

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.

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ISO
ISO 16840-12:2021(Main)
Wheelchair seating — Part 12: Envelopment and immersion characterization of seat cushions using a dual semispherical indenter

This document specifies apparatus, test methods, and disclosure requirements for characterization of wheelchair seat cushion immersion and envelopment properties using indenters instrumented with pressure sensors. This document expands the characterization of products intended to manage tissue integrity (ISO 16840‑2) and provides a standardized indenter for other wheelchair seating tests. It does not provide information specific to cushion performance for a particular individual user, nor is it intended to characterize envelopment or immersion under higher loading conditions, nor to assess the weight capacity of a cushion. This document includes a method that is specific to 220 mm and 255 mm indenters. Dimensions are provided for a 380 mm indenter to allow for extension of the method to larger patient simulation.

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ISO
ISO 10535:2021(Main)
Assistive products — Hoists for the transfer of persons — Requirements and test methods

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.

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SIST
SIST EN ISO 11199-2:2021(Main)
Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2021)
EN ISO 11199-2:2021

This document specifies requirements and test methods of rollators being used as assistive products for
walking with wheels, manipulated by both arms, without accessories, unless specified in the particular
test procedure. This document also gives requirements relating to safety, ergonomics, performance and
information supplied by the manufacturer including marking and labelling.
The requirements and tests are based on every-day use of rollators as assistive products for walking
for a maximum user mass as specified by the manufacturer. This document includes rollators specified
for a user mass of no less than 35 kg.
This document is not applicable to rollators with horizontal forearm supports, classified as walking
tables, for which ISO 11199-3 is applicable.

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ISO
ISO 11199-2:2021(Main)
Assistive products for walking manipulated by both arms — Requirements and test methods — Part 2: Rollators

This document specifies requirements and test methods of rollators being used as assistive products for walking with wheels, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer including marking and labelling. The requirements and tests are based on every-day use of rollators as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes rollators specified for a user mass of no less than 35 kg. This document is not applicable to rollators with horizontal forearm supports, classified as walking tables, for which ISO 11199-3 is applicable.

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SIST
SIST EN ISO 11199-1:2021(Main)
Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1:2021)
EN ISO 11199-1:2021

This document specifies requirements and test methods for walking frames used as assistive products
for walking, manipulated by both arms, without accessories, unless specified in the particular test
procedure. This document also gives requirements relating to safety, ergonomics, performance and
information supplied by the manufacturer, including marking and labelling.
The requirements and tests are based on everyday use of walking frames as assistive products for
walking for a maximum user mass as specified by the manufacturer. This document includes walking
frames specified for a user mass of no less than 35 kg.

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ISO
ISO 16840-13:2021(Main)
Wheelchair seating — Part 13: Determination of the lateral stability property of a seat cushion

This document specifies apparatus, test methods, and disclosure requirements for determination of lateral stability properties of wheelchair seat cushions by measuring the response from the cushion to a shift in the centre of mass of the load on the cushion. It provides a method of determining changes in a particular physical and mechanical property of the cushion. It does not provide information specific to cushion performance for a particular individual user. It does not provide information related to anterior-posterior stability, nor to stability contributions from cushion edges. NOTE 1 Test conditions simulate a symmetric anatomy. NOTE 2 Loads are intended to represent those seen under the pelvis of a 40th to 60th percentile wheelchair user. This document is applicable to cushions used in situations other than a wheelchair.

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ISO
ISO 16840-10:2021(Main)
Wheelchair seating — Part 10: Resistance to ignition of postural support devices — Requirements and test method

This document specifies requirements and test methods to assess the resistance to ignition by smouldering cigarette equivalent of integrated or non-integrated components of a wheelchair intended to protect tissue integrity and/or provide postural support. The electronic ignition source is also a simulation of other potential sources of environmental ignition hazards. The tests measure only the resistance to ignition of the items tested, and not the ignitability of the complete wheelchair. It gives an indication, but cannot guarantee, the ignition behaviour of the assembled devices of a complete wheelchair. This document does not apply to resistance to ignition of structural parts of a wheelchair. This document does not cover changes in resistance to ignition as a result of regular washing or use of the postural support devices. This document does not apply to the control of risks created by electrical and electronic components. This document allows for the separate testing of components of a wheelchair that are normally used in the horizontal plane (e.g. a seat cushion) from those normally used in the vertical plane (e.g. a back support). This document describes testing an assembly of the composite of materials as used in the component. The results of the tests in this document do not give any indication of the resistance to ignition of any of the separate individual materials of the test sample. NOTE The intent of this document is primarily to address components that interface with the human body, such as cushions for positioning, or whose described purpose is that of protecting skin tissue against pressure, shear, and maceration related damage, as well as textile, foam, and plastic-based postural support devices.

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ISO
ISO 11199-1:2021(Main)
Assistive products for walking manipulated by both arms — Requirements and test methods — Part 1: Walking frames

This document specifies requirements and test methods for walking frames used as assistive products for walking, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling. The requirements and tests are based on everyday use of walking frames as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes walking frames specified for a user mass of no less than 35 kg.

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ISO
ISO 10542-1:2012/Amd 1:2021(Amendment)
Technical systems and aids for disabled or handicapped persons — Wheelchair tiedown and occupant-restraint systems — Part 1: Requirements and test methods for all systems — Amendment 1: Annexes K, L, M
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SIST
SIST EN 81-40:2020(Main)
Safety rules for the construction and installation of lifts - Special lifts for the transport of persons and goods - Part 40: Stairlifts and inclined lifting platforms intended for persons with impaired mobility
EN 81-40:2020

1.1   This European Standard deals with safety requirements for construction, manufacturing, installation, maintenance and dismantling of electrically operated stairlifts (chair, standing platform and wheelchair platform) affixed to a building structure, moving in an inclined plane and intended for use by persons with impaired mobility:
-   travelling over a stair or an accessible inclined surface;
-   intended for use by one person;
-   whose carriage is directly retained and guided by a guide rail or rails;
-   supported or sustained by rope (5.4.4), rack and pinion (5.4.5), chain (5.4.6), friction traction drive (5.4.7), and guided rope and ball (5.4.8).
1.2   The standard identifies hazards as listed in Clause 4 which arise during the various phases in the life of such equipment and describes methods for the elimination or reduction of these hazards when used as intended by the manufacturer.
1.3   This European standard does not specify the additional requirements for:
-   operation in severe conditions (e.g. extreme climates, strong magnetic fields);
-   operation subject to special rules (e.g. potentially explosive atmospheres);
-   handling of materials the nature of which could lead to dangerous situations;
-   use of energy systems other than electricity;
-   hazards occurring during manufacture;
-   earthquakes, flooding, fire;
-   evacuation during a fire;
-   stairlifts for goods only;
-   concrete, hardcore, timber or other foundation or building arrangement;
-   design of anchorage bolts to the supporting structure.
NOTE   For the actual type of machinery, noise is not considered a significant nor relevant hazard.
1.4   This document is not applicable to power operated stairlifts which are manufactured before the date of publication of this document by CEN.

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ISO
ISO 19894:2019(Main)
Walking trolleys — Requirements and test methods

This document specifies the requirements and test methods for the testing strength, torque, and durability of parts, and stability and running durability as a whole for walking trolleys. This document also provides requirements relating to general safety, folding and adjusting mechanisms, lifting and carrying means, ergonomics and information supplied by the manufacturer including marking and labelling. The requirements and tests are based upon every-day usage of walking trolleys as assistive products for walking, for a maximum user mass as specified by the manufacturer. This document includes walking trolleys specified for a user mass of no less than 35kg. Excluded are rollators specified in ISO 11199-2.

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ISO
ISO 7176-30:2018(Main)
Wheelchairs — Part 30: Wheelchairs for changing occupant posture — Test methods and requirements

This document specifies the test methods and requirements for determining the safety and performance of a manual and/or power wheelchair that incorporates technology to alter the posture of the wheelchair occupant, which are either electrically or manually operated by the occupant or assistant during normal wheelchair use. This can include recline, tilt, elevate and stand-up mechanisms or a combination of these. In order for a wheelchair to be able to recline, tilt, elevate and/or stand-up, the wheelchair requires additional mechanisms and mechanical structures to allow these features to operate. This document specifies the different functional and strength tests required to test these wheelchairs in critical configurations of their adjustable range. This document does not cover wheelchairs where the only operator adjustable body support system (OABSS) is adjustable limb or head postural support devices alone (e.g. elevating leg supports). This document does not include wheelchair and postural support device customization during initial or subsequent setup of a wheelchair for an individual occupant. It also does not reflect other factors that can influence wheelchair stability such as occupant movement, cushion thickness, and the addition of ancillary equipment (e.g. respiratory support items).

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ISO
ISO 7176-6:2018(Main)
Wheelchairs — Part 6: Determination of maximum speed of electrically powered wheelchairs

This document specifies test methods for determining the maximum speed of electrically powered wheelchairs, including scooters, intended to carry one person with a maximum nominal speed not exceeding 15 km/h (4,167 m/s) on a level surface.

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ISO
ISO 16840-2:2018(Main)
Wheelchair seating — Part 2: Determination of physical and mechanical characteristics of seat cushions intended to manage tissue integrity

ISO 16840-2:2018 specifies apparatus, test methods and disclosure requirements for wheelchair seat cushions intended to maintain tissue integrity and prevent tissue trauma. Test conditions simulate a symmetric anatomy and posture and do not represent cushion performance for specific individual users. Loads are intended to represent those seen under the pelvis of a 50th percentile wheelchair user and are not intended to assess the weight capacity of the cushion or to characterize the cushion under bariatric loads. It is possible that not all test methods apply to existing and future cushion technologies. It does not include test methods or requirements for determining the fire resistance of cushions. ISO 16840-2:2018 can also be applicable to tissue integrity management devices used as other support systems, as well as to cushions used in situations other than a wheelchair.

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ISO
ISO 7176-2:2017(Main)
Wheelchairs — Part 2: Determination of dynamic stability of electrically powered wheelchairs

ISO 7176-2:2017 specifies test methods for determining the dynamic stability of electrically powered wheelchairs. ISO 7176-2:2017 is applicable to electrically powered wheelchairs, including scooters, with a maximum nominal speed not exceeding 15 km/h, intended to carry one person. ISO 7176-2:2017 is not applicable to manual wheelchairs with add-on power kits used for, or to assist, propulsion.

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CEN
EN ISO 10328:2016(Main)
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
SIST EN ISO 10328:2016

IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to ISO 22675:2016.
WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.
ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.

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CEN
EN ISO 22675:2016(Main)
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
SIST EN ISO 22675:2016

IMPORTANT ? ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to this International Standard.
WARNING ? ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.
ISO 22675:2016 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, ISO 22675:2016 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
The loading conditions addressed in the third paragraph are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.

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ISO
ISO 16840-6:2015(Main)
Wheelchair seating — Part 6: Simulated use and determination of the changes in properties of seat cushions

ISO 16840-6:2015 specifies apparatus, test methods, and disclosure requirements for generating aging effects in a seat cushion that reproduce those seen in use. It also provides methods of determining changes in the physical and mechanical properties of seat cushions based on their age and use. ISO 16840-6:2015 provides a set of tests that simulate wear and tear, which can be useful to validate warranty claims and to provide information about product, life, and performance limitations associated with product use.

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ISO
ISO 10865-2:2015(Main)
Wheelchair containment and occupant retention systems for accessible transport vehicles designed for use by both sitting and standing passengers — Part 2: Systems for forward-facing wheelchair-seated passengers

ISO 10865-2:2015 applies to wheelchair passenger spaces that are intended for use by passengers with a body mass greater than 22 kg who remain in their wheelchairs when travelling facing forward in accessible transport vehicles designed to transport both standing and sitting passengers on fixed-route service. It assumes that the maximum acceleration imparted to the vehicle during emergency driving manoeuvres will not exceed 1 g in any direction and rarely exceeds 3 g in frontal crashes. For the purposes of this part of ISO 10865, the term wheelchair includes manual and powered wheelchairs, and three and four wheeled scooters. ISO 10865-2:2015 specifies performance requirements and associated test methods, design requirements, requirements for manufacturer instructions and warnings to installers, wheelchair users, and vehicle operators, and requirements for product labelling and disclosure of test information. The provisions of this part of ISO 10865 apply primarily to a complete forward-facing wheelchair passenger space (FF-WPS), but subsets of the provisions can be applied to components and subassemblies sold separately, as appropriate to the specific functions of the components and/or subassemblies they are intended to replace.

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ISO
ISO/TR 16840-9:2015(Main)
Wheelchair seating — Part 9: Clinical interface pressure mapping guidelines for seating

ISO/TR 16840-9:2015 has been produced to guide users in the performance of the tasks that are directly involved in the clinical use of interface pressure mapping (IPM) or are synergistic with its use in a comprehensive wheelchair seating evaluation. ISO/TR 16840-9:2015 does not cover other aspects of the clinical assessment process (e.g. taking a medical history), nor the prescription or treatment process which might arise from an assessment. These guidelines are not meant to be a substitute for clinical reasoning and judgement within the context of a complete assessment. ISO/TR 16840-9:2015 refers to the state of the art of IPM experiences in a seating scenario. Most of the principles covered can be extrapolated to whole body (in bed) or to foot assessments, for example.

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ISO
ISO 7176-8:2014(Main)
Wheelchairs — Part 8: Requirements and test methods for static, impact and fatigue strengths

ISO 7176-8:2014 specifies requirements for static, impact, and fatigue strength of wheelchairs including scooters. It specifies the test methods for determining whether the requirements have been met. It also specifies requirements for disclosure of the test results. The test methods can also be used to verify the manufacturers' claims that a product exceeds the minimum requirements of this part of ISO 7176. ISO 7176-8:2014 applies to occupant- and attendant-propelled manual wheelchairs and electrically powered wheelchairs intended to provide indoor and outdoor mobility for people with disabilities. NOTE 1 For the purposes of this part of ISO 7176, "wheelchair(s)" is used as an abbreviation for manual wheelchair(s) or electrically powered wheelchair(s), including scooter(s), to which the requirements and test methods are applied. NOTE 2 Clauses of this part of ISO 7176 will be used as a basis for developing requirements and test methods for wheelchairs not covered by this part of ISO 7176.

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ISO
ISO 7176-1:2014(Main)
Wheelchairs — Part 1: Determination of static stability

ISO 7176-1:2014 specifies test methods for determining the static stability of wheelchairs. It is applicable to manual and electrically powered wheelchairs, including scooters, with a maximum speed not greater than 15 km/h, intended to provide indoor and/or outdoor mobility for one disabled person whose mass is within the range represented by ISO 7176‑11. For active stability-controlled wheelchairs, ISO 7176-1:2014 applies to the device in a stable, parked state. ISO 7176-1:2014 provides a method for the measurement of the tipping angles (either wheelchair tipping angle or anti-tip device tipping angle), but this method is not applicable to wheelchairs with lateral anti-tip devices and does not consider sliding on the ground. ISO 7176-1:2014 also includes requirements for test reports and information disclosure.

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ISO
ISO 7176-22:2014(Main)
Wheelchairs — Part 22: Set-up procedures

ISO 7176-22:2014 specifies a set-up procedure to be used as a part of the preparation of adjustable wheelchairs for testing. This procedure takes the manufacturer's instructions into account. ISO 7176-22:2014 is applicable to manual wheelchairs and electric wheelchairs (including scooters) intended to provide indoor and/or outdoor mobility.

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ISO
ISO/TR 13570-2:2014(Main)
Wheelchairs — Part 2: Typical values and recommended limits of dimensions, mass and manoeuvring space as determined in ISO 7176-5

ISO/TR 13570-2:2014 lists the typical values and recommended limits of the dimensions obtained from measurements taken in accordance with ISO 7176‑5. ISO/TR 13570-2:2014 lists the typical values and recommended limits of the important wheelchair dimensions (ready for occupation and folded or dismantled), space for pivoting or reversing between limiting walls and some dimensions worthwhile to estimate usability of the wheelchair as well as determination of the mass of the wheelchair. It is intended for use of prescribers, clinicians, wheelchair occupants or manufacturers. ISO/TR 13570-2:2014 lists the typical values and recommended limits of the dimensions when the wheelchair is occupied and some operating areas when performing special tasks encountered in every day's life. ISO/TR 13570-2:2014 lists the typical values and recommended limits of the technical dimensions critical to the performance of the wheelchair. ISO/TR 13570-2:2014 applies to manual wheelchairs and electrically powered wheelchairs (including scooters).

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ISO
ISO 7176-3:2012(Main)
Wheelchairs — Part 3: Determination of effectiveness of brakes

ISO 7176-3:2012 specifies test methods for the measurement of the effectiveness of brakes of manual wheelchairs and electrically powered wheelchairs, including scooters, intended to carry one person, with a maximum speed not exceeding 15 km/h. It also specifies disclosure requirements for the manufacturer.

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ISO
ISO 7176-11:2012(Main)
Wheelchairs — Part 11: Test dummies

ISO 7176-11:2012 specifies requirements for test dummies of any mass greater than or equal to 25 kg, to be used in the evaluation of wheelchairs. ISO 7176-11:2012 provides formulae that specify the location of the overall centre of mass of test dummies, the masses of the segments that comprise the test dummies and the locations of pivots that connect the segments. It also specifies the characteristics of loading pads that support the segments. ISO 7176-11:2012 is intended to enable the construction of test dummies that will produce comparable results for stability, performance and durability testing of manual wheelchairs and electrically powered wheelchairs, including scooters. ISO 7176-11:2012 also includes informative tables of mass and locations of centre of mass, which are derived from the formulae, corresponding to example test dummy masses up to 300 kg in 25 kg increments.

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ISO
ISO 7176-28:2012(Main)
Wheelchairs — Part 28: Requirements and test methods for stair-climbing devices

ISO 7176-28:2012 is applicable to stair-climbing chairs and stair-climbing wheelchair carriers where the stair-climbing device climbs backwards up the stairs, with the occupant facing downstairs, and climbs forwards down the stairs with the occupant also facing downstairs. ISO 7176-28:2012 is applicable to stair-climbing devices which are intended for the transport of adults and those intended for the transport of children. It is not applicable to stair-climbing devices which are intended to be operated by children as operating occupants or assistants. ISO 7176-28:2012 specifies requirements and test methods for electrically powered stair-climbing devices. It is not applicable to manually powered stair-climbing devices. ISO 7176-28:2012 specifies tests to demonstrate the stair-climbing device's ability to perform safely on stairs with a pitch of 35°, or higher if declared by the manufacturer. It also includes ergonomic, labelling and disclosure requirements.

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ISO
ISO 10542-1:2012(Main)
Technical systems and aids for disabled or handicapped persons — Wheelchair tiedown and occupant-restraint systems — Part 1: Requirements and test methods for all systems

This part of ISO 10542 specifies design and performance requirements and associated test methods for wheelchair tiedown and occupant-restraint systems (WTORS), as well as requirements for product marking and labelling and manufacturers' instructions and warnings to installers and consumers. It is applicable to all WTORS that use belt-type occupant restraints that are intended for occupied wheelchairs used as forward-facing seats by passengers and drivers of motor vehicles. This part of ISO 10542 is applicable to WTORS intended for use with all types of manual and powered wheelchairs, including three- and four-wheeled scooters, used by children and adults with a body mass equal to or greater than 22 kg. It is applicable also to WTORS designed for limited use with a particular make or model of wheelchair. This part of ISO 10542 is applicable primarily to complete WTORS, but portions can also be applied to components and subassemblies sold separately and for replacement parts.

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