ISO/TC 173 - Assistive products

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201). This document applies to both electrical and non-electrical(manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm. If a MANUFACTURER wishes to make a bed that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply. This document does not apply to: • ADULT only beds covered by IEC 80601-2-52; • SPECIALITY MATTRESS covered by the ISO 20342 series; • incubators covered by IEC 60601-2-19; • devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table). If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.

This document specifies requirements and test methods for electromagnetic emissions and for electromagnetic immunity of electrically powered wheelchairs and scooters, intended for indoor or outdoor use, or both, by people with disabilities. It is also applicable to manual wheelchairs with an add-on power kit. It is not applicable to vehicles designed to carry more than one person. This document also specifies requirements and test methods for the electromagnetic compatibility of battery chargers intended for use with electrically powered wheelchairs and scooters. A reference configuration is specified for adjustable wheelchairs and scooters in order to enable test results to be used for comparison of performance.

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 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.

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 provides guidelines and requirements for surveying the user needs for assistive products and services of persons with sensory disabilities related to seeing and hearing. This document does not provide guidelines or requirements for other disabilities such as physical, mental or cognitive. The methods described in the document do not reflect all possible methods for surveying, but are those most frequently used for assessing user needs.

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.

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.

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 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.

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.

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 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 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.

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.

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.

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 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.

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.

This document specifies requirements for water-absorbent crosslinked polyacrylate in urine absorbing products.

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 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 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.

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.

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 provides a test method for determining the sum of residual monomeric sodium acrylate and acrylic acid present in polyacrylate superabsorbent powders as acrylic acid.

This document provides a test method for measuring the permeability-dependent absorption under pressure (PDAUP) of polyacrylate superabsorbent powder, where permeability is a significant controlling factor under the conditions of the test.

This document provides a test method for determining the pH of granular superabsorbent polyacrylates.

This document provides a test method that determines the capacity of polyacrylate superabsorbent powders to absorb saline solution under a specified enclosing pressure.

This document provides a test method for the evaluation of mass loss upon heating for cross-linked polyacrylate superabsorbent powders. This method is applicable to powdered polymeric superabsorbent materials that are free-flowing under the specified test conditions. Substances other than water that are volatile in this temperature range will interfere. The onus is on the polymer formulator/producer to decide if such interference is possible and either exclude the method from use, provide an alternative or modify the method accordingly.

This document provides a test method that determines the free swell capacity of polyacrylate superabsorbent powders in saline solution.

This document provides a test method to determine the mass fraction of soluble polymers present in crosslinked polyacrylate superabsorbent powders that can be extracted into saline solution.

This document provides a test method for the determination of the fluid retention capacity of polyacrylate superabsorbent powders in saline solution, following centrifugation.

This document provides a test method to determine the mass flow rate and bulk density (or apparent density) of polyacrylate superabsorbent powders.

This document specifies a test method for measuring particle size distributions up to 850 µ of cross-linked polyacrylate superabsorbent powders. It applies only to measurements made where sieve shaking is used for the separation. Tapping equipment is not expected to deliver the same results. This method is applicable to powdered polymeric superabsorbent materials that are free-flowing under the specified test conditions.

This document specifies considerations to be taken, as well as support and assistive products that can be used when organizing a physical meeting in which older persons and persons with disabilities can actively participate. Teleconferences and web conferences are important methods that can be used to include older persons and persons with disabilities in meetings.

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.

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.