CEN/TC 293 - Technical aids for disabled persons

This document specifies requirements and test methods of walking sticks with three or more legs used as assistive products for walking, manipulated by one arm, without accessories, unless specified in the particular test procedure. This document also gives requirements related 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 walking sticks with three or more legs as assistive products for walking for a maximum user mass as specified by the manufacturer. This document is for walking sticks with three or more legs specified for a user mass of no less than 35 kg.
This document is not applicable to walking sticks with three or more legs with underarm or forearm support or with moving parts such as a universal joint.

This document specifies a test method to evaluate the effects of liquid cleaners and disinfectants on the properties of waterproof coated textiles that are used as the protective outer surface of assistive products for tissue integrity (APTIs).
The test method is not applicable to outer surfaces of APTIs that are not sufficiently drapeable.
The test addresses degradation by pure chemical contact time only, it does not address degradation by other factors, such as abrasion.

This document provides guidelines and requirements for designing and conducting an evaluation of single-use adult incontinence absorbing products. It provides guidelines and requirements on creating data collection tools. In particular, it provides a framework for eliciting and recording the views of users and their carers on the acceptability of products. In addition, a product diary is described which can help to quantify some parameters of product use, such as wear times, the mass of urine absorbed by the product and the severity of any leakage from it.
This document does not cover direct comparison between products based on statistical parameters, neither does it provide guidelines on measuring the clinical efficacy of products; that is available in ISO 14155.

This document specifies general requirements and test methods for assistive products, considered to be medical devices, intended for use to alleviate or compensate for a disability.
This document does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
NOTE 1    Assistive products are considered to be medical devices in some jurisdictions but not in others.
NOTE 2    Requirements and test methods for particular types of assistive products are given in other International Standards, e.g. see Reference [33].
NOTE 3    Not all the items listed in ISO 9999 are medical devices. Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for assistive products that are not medical devices.

This document specifies a classification and terminology of assistive products, especially produced or generally available, for persons to optimize functioning and reduce disability.
Assistive products used by a person to optimize functioning and reduce disability, but which require the assistance of another person for their operation, are included in the classification.
The following items are specifically excluded from this document:
—    items used for the installation of assistive products;
—    solutions obtained by combinations of assistive products that are individually classified in this document;
—    medicines;
—    assistive products and instruments used exclusively by healthcare professionals or by teachers;
—    non-technical solutions, such as personal assistance, guide dogs or lip-reading;
—    implanted devices;
—    financial support.

This document specifies requirements for reporting the cognitive accessibility of systems, including assistive products, assistive technologies, consumer technologies, and household appliances, according to the recommendations given in ISO 21801-1:2020.

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.

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.

This document specifies general requirements and related test methods that are relevant to assistive products for tissue integrity (APTI) in the lying position in different application environments such as hospitals, home care and institutions. This document applies to the safety of APTI that are intended to remain in situ during periods of lying, and to prevent and/or treat pressure injuries.
This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform (adjustable included) or as a whole integrated system.
This document does not apply to medical beds.
This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position.
This document does not apply to lying support surfaces used in combination with incubators or operating/surgical tables.
It also covers safety and performance test methods to ensure protection against injuries to the user.
This document addresses the combination of a full body support surface and an adjustable mattress support platform. It also covers safety and performance test methods to ensure protection against injuries to the user.
This document specifies requirements and test methods for APTI within the following classifications of ISO 9999:2022:
04 33 06 Assistive products for tissue integrity when lying down such as but not limited to
—    mattresses and mattress overlays for pressure injury prevention, and
—    mattress coverings for pressure injury prevention mattresses.
12 31 03 Assistive products for sliding and turning such as but not limited to the following:
Devices for changing position or direction of a person using sliding or turning techniques. The only products included are those intended to be used in a lying position and remain in situ as part of the lying support surface. They are the following:
—    sliding products that glide one way and lock the other way;
—    sheets and underlays in flexible materials with low friction;
—    fabric sold by the metre, cut as required for repositioning use;
—    powered turning product;
This excludes sliding boards unless the product is intended to be left in situ.
09 07 06 Positioning pillows, positioning cushions and positioning systems such as but not limited to
—    leg positioners,
—    arm positioners, and
—    multipurpose body positioners.
18 12 15 Bedding such as but not limited to
—    draw sheets.

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 lists the terminology and common test methods used by manufacturers and laboratories to quantify the performance of a foam material. It also and gives information to users or buyers of these products to make an educated assessment of the relevance of the physical characteristics between various products offered to them.
This document summarizes/gives information about the tests for
—    polyurethane foams – typically polyether (polyether polyurethane foam) or polyester based (polyester polyurethane foam) – produced by either slabstock (slabstock foam) or moulded foam process, and
—    latex foams produced by either the Dunlop process or Talalay process.
The physical properties addressed in this document are
a) resilience,
b) hysteresis,
c) support/SAG factor,
d) density,
e) hardness,
f) compression set,
g) tensile strength,
h) tear strength,
i) air flow/permeability,
j) resistance to fatigue, and
k) microbial resistance.
NOTE       The test methods presented in this document do not necessarily simulate conditions of use in practice. The use of resulting data is therefore restricted to a broad comparative assessment between different foam products.
This document addresses only the characterization and performance of foam materials used in APTIs. It does not address the design, construction method or other factors relating to the final clinical efficiency of the product.
Test methods for characterizing the physical properties of any coverings, or the effects of any coverings on the physical properties of the foams, are not addressed in this document.

This document provides guidance around best practices for cleaning, disinfecting and caring for the polyurethane covers for assistive products for tissue integrity when lying down (APTIs) where the covers are designed to protect the internal components of the APTI from damage. Adherence to this guidance will extend the operational life of the APTI and its tissue integrity performance.
This document gives guidance for cleaning and disinfecting by manual means only.
This document is not intended to give guidance related to the efficacy of the cleaning and disinfection procedures.

This document specifies principles of cognitive accessibility within the area of daily time management.
This document gives guidelines for design application for features and functions known to increase the accessibility of products and systems used to support daily time management for people with cognitive impairment regardless of age.
This document does not provide test methods and specific instructions for measuring and reporting.
NOTE       ANSI/RESNA CA-1:2016 specifies features, measurement methods, and documentation for reporting the universal design specifications that support inclusion of individuals with cognitive impairment that might be applicable and beneficial to use for evaluating products and systems used to support daily time management.

This document provides recommended and other product type names and example pictures of product categories defined in ISO 9999, subclass 09 30, "Absorbing products to contain urine and faeces".

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.

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.

This document presents guidelines for the design and development of cognitively accessible systems, including products and services and built environments.
This document is relevant to mainstream systems as well as those designed specifically for people with disability.
Within the broad field of accessibility, this document is limited to guidance related to cognitive accessibility.
NOTE 1  It acknowledges, however, that diverse sensory perceptions can impact cognitive accessibility.
NOTE 2  While the following guidance in this document can benefit all users, it is included here because failure to follow it could lead to barriers that would prevent some potential users from being able to use the system at all.
This document is relevant to all types of systems. However, some particular recommendations can only be followed for some types of systems:
—     Some of the guidance is relevant to a fixed system (e.g. a non-computerized consumer product or a user manual);
—     Some of the guidance applies to systems containing some level of computer-based processing (e.g. a microwave oven or an ICT-system);
—     Some of the guidance applies to systems that use advanced computer processing that supports individualization (e.g. an application in a smart phone);
—     Some guidance applies to combinations of the above.

ISO 15621:2017 gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.

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.

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.

ISO 24415-1:2009 specifies requirements and test methods for the friction between the tips for assistive products for walking and the walking surface. The requirements and test method are based on a usage of tips for ordinary gait on the dry and flat walking surface.
ISO 24415-1:2009 is not applicable to tips manufactured for special purposes.

ISO 11334-1:2007 specifies requirements and test methods for elbow crutches fully equipped with handgrip and tip. The methods specify testing of separation, static load capacity, fatigue and resistance to low temperature embrittlement.
ISO 11334-1:2007 also gives the requirements relating to safety, ergonomics, performance, and information to be supplied by the manufacturer, including marking and labelling.
The requirements and tests are based on every-day usage of elbow crutches when performing the through-swing gait, for a maximum user mass as specified by the manufacturer. ISO 11334-1:2007 is applicable to elbow crutches specified for a user mass of not less than 35 kg.
Requirements and test methods for friction of rubber tips against the walking surface are dealt with separately.

ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:
06 03 - 06 15 Orthoses06 18 - 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.

ISO 11199-3:2005 specifies requirements and methods of testing the static stability, braking capabilities, static strength and fatigue of walking tables without accessory equipment, unless specified in the particular test procedure. It also gives requirements relating to safety, ergonomics and performance, marking, labelling and information supplied by the manufacturer.
ISO 11199-3:2005 includes all walking tables with three or more wheels or tips against the walking surface and having arm supports in the shape of a horizontal supporting table or two horizontal forearm supports.
The requirements and tests are based on everyday usage of walking tables as walking aids, for a maximum user mass as specified by the manufacturer.
ISO 11199-3:2005 includes walking tables specified for a user mass of not less than 35 kg.

This standard specfies requirements and test methods for Walking Aids manipulated by one arm (Walking Aids used singly or in pairs, each manipulated by one arm, possibly in combination with the upper body) and Walking Aids manpulated by both arms (Walking Aids used singly, manipulated by both arms, possibly in combination with the upper body), as covered by the subclasses 1203 and 1206 in EN ISO 9999:1998.  This standard does not apply to walking aids specially designed or with adaptations for specific disabled persons.  NOTE: Appropriate parts of this standard may be applied to the above products and other walking aids outside this scope.

Gives performance requirements and test methods for one-piece and multiple-piece ostomy systems having open-ended and closed-ended collection bags. Replaces the first edition.

Gives performance requirements and test methods for body-worn and non-body-worn open-ended and closed urine collection bags. Does not apply to urine bags for paediatric uses. Replaces the first editions of ISO 8669-2, ISO 8669-3 and ISO 8669-4.

This document specifies requirements and associated test methods for assistive products
for toileting, bathing and showering (from herein referred as ‘assistive product’ within the document)
and which are considered to be medical devices, intended by the manufacturer to alleviate or
compensate for disability.
NOTE  Assistive products are considered to be medical devices in some jurisdictions but not in others.
The work environment and safety aspects for assistants are also included. It specifies safety and
performance requirements that apply during normal use and foreseeable misuse and failure. It also
specifies methods of measurement of the forces necessary to operate controls and specifies limits on
the forces needed for some operations.
This document specifies requirements and test methods for assistive products within the
following divisions of ISO 9999:
09 12 03 Commode chairs;
09 12 06 Toilets;
09 12 09 Toilet seats;
09 12 10 Toilet splash guards;
09 12 12 Raised toilet seats mounted on frame;
09 12 15 Toilet seats inserts;
09 12 18 Raised toilet seats fixed to toilet;
09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down;
09 12 24 Toilet arm supports and toilet back supports mounted on toilet;
09 12 25 Toilet arm supports and toilet back supports, free standing;
09 12 36 Douches and air dryers for attachment to a toilet;
09 33 04 Bath boards
09 33 05 Bath seats
09 33 07 Shower chairs with and without wheels
09 33 08 Back supports for bath or shower
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
NOTE: Mainstream diaper-changing tables for babies/toddlers are excluded. They are
covered by EN 12221-1 and EN 12221-2.
09 33 15 Wash basins
NOTE: General requirements for wash basins are covered by EN 14688.
09 33 18 Bidets
09 33 21 Bathtubs
09 33 36 Assistive products for drying oneself
18 15 06 Height adjustable plinths and brackets;
18 18 03 Handrails and support rails;
18 18 06 Fixed grab bars and handgrips;
18 18 10 Removable grab rails and handgrips;
18 18 11 Hinged rails and arm supports;
This document does not encompass requirements regarding:
— safe mounting in building structures;
— fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation
to excretion-disposal and -wrapping systems;
— 12 36 15 bathtub hoists that are covered by ISO 10535;
— 09 33 21 Bathtubs
— stability and friction issues in relation to slippery surfaces due to soap;
— products that have been customised or custom-made for an individual user.
NOTE: this list is based on ISO 9999:2016, however in the revision process, this will be updated to corresponding codes of ISO 9999:2022

This document specifies requirements, recommendations, and guidance on aspects of accessible systems for living independently (ASLI) in relation to technical solutions, service design, provision, and information. This includes adapting design and functionality of systems, to allow ease of use by any user, regardless of their abilities.
This document does not cover system-to-system communication.
This document is not applicable to household and similar electrical appliances covered by EN IEC 63008 [10].

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.

ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:
06 03 - 06 15 Orthoses06 18 - 06 27 Limb prostheses
It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.

ISO 22675:2006 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.
In addition, ISO 22675:2006 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, 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.

2015-11-30: Project cancelled in ISO, awaiting BT decision to cancel CEN project (notification to dataservice 2015-11-12).

2015-11-30: Project cancelled in ISO, awaiting BT decision to cancel CEN projec (notification to dataservice 215-11-12).
2012-12-13 GVN: Draft for // vote received at ISO/CS (see notification in dataservice on 2012-12-12)

To provide guidelines for designing and conducting a user evaluation of single-use incontinence absorbing aids.

This European Standard specifies requirements and test methods for electrically powered wheelchairs, including electrically powered scooters with three or more wheels, with a maximum speed not exceeding 15 km/h intended to carry one person of mass not greater than 300 kg.
It also specifies requirements and test methods for battery chargers for wheelchairs and scooters.
This European Standard does not apply in total to:
-   electrically powered wheelchairs intended for special purposes, such as sports, showering or toileting,
-   manual wheelchairs with handrim-activated power-assisted propulsion,
-   custom-made electrically powered wheelchairs,
-   electrically powered stand-up wheelchairs,
-   manual wheelchairs with add-on power kits used for propulsion and
-   electrically powered office chairs.
NOTE   Requirements for manually propelled wheelchairs are specified in EN 12183.

This European Standard specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 250 kg.
It also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.
This European Standard does not apply in total to:
-   wheelchairs intended for special purposes, such as sports, showering or toileting,
-   manual wheelchairs with handrim-activated power-assisted propulsion,
-   custom-made wheelchairs,
-   stand-up wheelchairs, and
-   manual wheelchairs with add-on power kits used for propulsion.
NOTE   Requirements for electrically powered wheelchairs are specified in EN 12184.

This document specifies general requirements and related test methods that are relevant to assistive products for tissue integrity (APTI) in the lying position in different application environments such as hospitals, home care and institutions. This document applies to the safety of APTI, which are intended to remain in situ during periods of lying, and to prevent and/or treat pressure injuries.
This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform or as a whole integrated system.
This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position.
This document does not apply to lying support surfaces used in combination with incubators.
This document addresses the combination of a full body support surface and an adjustable mattress support platform. It also covers safety and performance test methods to ensure protection against injuries to the user.
This document specifies requirements and test methods for APTI within the following classifications of ISO 9999:2016:
04 33 06 Assistive products for tissue integrity when lying down such as but not limited to:
—         Mattresses and mattress overlays for pressure injury prevention;
—         Mattress coverings for pressure injury prevention mattresses.
12 31 03 Assistive products for sliding and turning such as but not limited to:
Devices for changing position or direction of a person using sliding or turning techniques. The only products included are those intended to be used in a lying position and remain in situ as part of the lying support surface. They are the following:
—         sliding products that glide one way and lock the other way;
—         sheets and underlays in flexible materials with low friction;
—         fabric sold by the metre, cut as required for repositioning use;
—         powered turning product;
This excludes sliding boards unless the product is intended to be left in situ.
09 07 06 Positioning pillows, positioning cushions and positioning systems such as but not limited to:
—         leg positioners,
—         arm positioners, and
—         multipurpose body positioners.
18 12 15 Bedding such as but not limited to:
—         draw sheets.

This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC.
This European Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
Where other European Standards exist for particular types of assistive products then those standards apply. However, some of the requirements of this standard may still apply and may be considered in addition to those in other European standards.
NOTE   Not all the items listed in EN ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of this standard can be used for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC.

ISO 16201:2006 specifies functional and technical requirements and test methods for environmental control systems intended for use to alleviate or compensate for a disability. Such systems are also known as electronic aids to daily living.
The aim of ISO 16201:2006 is to provide safety requirements and recommendations for manufacturers of such environmental control systems.
Target devices are not covered by ISO 16201:2006. Technical requirements for items of equipment connected within the system are to be covered by their own specific standards, e.g. adjustable beds.

ISO 9999:2016 establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability.
Assistive products used by a person with disability, but which require the assistance of another person for their operation, are included in the classification.
The following items are specifically excluded from this International Standard:
-      items used for the installation of assistive products;
-      solutions obtained by combinations of assistive products that are individually classified in this International Standard;
-      medicines;
-      assistive products and instruments used exclusively by healthcare professionals;
-      non-technical solutions, such as personal assistance, guide dogs or lip-reading;
-      implanted devices;
-      financial support.

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

ISO 11199-2:2005 specifies requirements and methods of testing the static stability braking capabilities, static strength and fatigue of rollators being used as walking aids with wheels, manipulated by the hands, without accessories, unless specified in the particular test procedure. ISO 11199-2:2005 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 usage of rollators as walking aids, for a maximum user mass as specified by the manufacturer. ISO 11199-2:2005 includes rollators specified for a user mass of no less than 35 kg.
ISO 11199-2:2005 is not applicable to rollators with horizontal forearm supports, classified as walking tables, for which ISO 11199-3 is applicable.

ISO 9999:2011 establishes a classification of assistive products, especially produced or generally available, for persons with disability.
Assistive products used by a person with disability, but which require the assistance of another person for their operation, are included in the classification.
The following items are specifically excluded from ISO 9999:2011: items used for the installation of assistive products; solutions obtained by combinations of assistive products that are individually classified in ISO 9999:2011; medicines; assistive products and instruments used exclusively by healthcare professionals; non-technical solutions, such as personal assistance, guide dogs or lip-reading; implanted devices; and financial support.

ISO 22675:2006 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.
In addition, ISO 22675:2006 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, 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.

ISO 10328:2005 specifies procedures for static and cyclic strength tests on lower-limb prostheses where, with one exception, compound loadings are produced 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.
The tests described in ISO 10328:2005 comprise:
principal static and cyclic tests for all components;
a separate static test in torsion for all components;
separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;
a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;
separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.
The tests described in this ISO 10328:2005 apply to specific types of ankle-disarticulation prostheses, to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses.

This European Standard specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 100 kg.
It also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.
This European Standard does not apply in total to:
-   wheelchairs intended for special purposes, such as sports, showering or toileting;
-   custom-made wheelchairs;
-   stand-up wheelchairs; and
-   add-on power kits for the propulsion of manual wheelchairs.
NOTE 1   The application of this standard is limited to wheelchairs with a maximum occupant mass of 100 kg because the maximum mass of dummy specified in ISO 7176-11:1992 is 100 kg. Annex A (informative) provides guidance for construction of dummies of mass 125 kg and 150 kg. At the time of publication, a new edition of ISO 7176-11 was under development, including test dummies with masses above 100 kg.
NOTE 2   Requirements for electrically powered wheelchairs are specified in EN 12184.