11.180 - Aids for disabled or handicapped persons
ICS 11.180 Details
Aids for disabled or handicapped persons
Hilfsmittel fur Behinderte
Aides pour les invalides ou handicapes
Pripomočki za invalide in funkcionalno ovirane osebe
General Information
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This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM)
services offered by hearing aid professionals (HAP). It focusses on tele-services which may substitute,
or complement services defined in ISO 21388, and it defines services which shall be provided in the
facilities of the HAP. Moreover, this document specifies important preconditions such as education,
facilities and systems that are required to ensure proper tele-services. If not other stated all definitions
and requirements of ISO 21388 also apply for this standard without further notice. Furthermore, it is
tried to keep the structure if ISO 21388 to make it easier to use both standards together. It is
recognized that certain populations with hearing loss such as children, persons with other disabilities or
persons with implantable devices can require services outside the scope of this document.
Other assisted tele-services provided by non-hearing aid professionals, self-fitting, and other nonhearing
care related will also be outside of the scope.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60118-0:2022 gives recommendations for the measurement of the performance characteristics of air conduction hearing aids measured with an acoustic coupler or occluded ear simulator.
This document is applicable to the measurement and evaluation of the electroacoustical characteristics of hearing aids, for example for type testing and manufacturer data sheets.
This document is also applicable for the measurement of the performance characteristics of hearing aids for production, supply and delivery quality-assurance purposes.
The measurement results obtained by the methods specified in this document will express the performance under conditions of the measurement and can deviate substantially from the performance of the hearing aid under actual conditions of use.
This document primarily uses an acoustic coupler according to IEC 60318-5 which is only intended for loading a hearing aid with specified acoustic impedance and is not intended to reproduce the sound pressure in a person's ear. For measurements reflecting the output level in the normal human ear the occluded ear simulator according to IEC 60318-4 can be used. For extended high-frequency measurements and for deep insert hearing aids, the acoustic coupler according to IEC 60318-8 can be used.
This document also covers measurement of hearing aids with non-acoustic inputs, such as wireless, inductive or electrical input.
This document does not cover the measurement of hearing aids for simulated in situ working conditions, for which IEC 60118-8 can be applied.
This document does not cover the measurement of hearing aids under typical user settings and using a speech-like signal, for which IEC 60118-15 can be applied.
IEC 60118-0:2022 merges and updates the methods previously described in IEC 60118-0:2015 and IEC 60118-7:2005. It cancels and replaces the third edition of IEC 60118-0 published in 2015. This edition constitutes a technical revision.
Measurements for quality control as described in IEC 60118-7:2005 can be found in Clause 10 of this document.
This edition includes the following significant technical changes with respect to previous editions:
a) the default use of an acoustic coupler according to IEC 60318-5,
b) addition of the optional use of an occluded ear simulator according to IEC 60318-4,
c) addition of the optional use of an acoustic coupler according to IEC 60318-8 (new standard based on IEC TS 62886) when information about the response above 8 kHz is needed, or the optional use of the acoustic coupler according to IEC 60318-8 for deep insert hearing aids,
d) the addition of measurements of the performance of hearing aids for production, supply and delivery quality assurance purposes,
e) corrected and updated measurement configuration and methods, adding the use of a sequential measurement as preferred configuration,
f) updated and expanded measurement procedures for the non-acoustic inputs of the hearing aid.
- Standard77 pagesEnglish languagesale 10% offe-Library read for1 day
This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP.
Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document.
Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP. Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.
- Standard12 pagesEnglish languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
- Standard4 pagesEnglish languagesale 15% off
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 specification51 pagesEnglish languagesale 15% off
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.
- Standard14 pagesEnglish languagesale 15% off
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.
- Standard14 pagesEnglish languagesale 15% off
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.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard11 pagesEnglish languagesale 15% off
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.
- Standard19 pagesEnglish languagesale 15% off
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 specification12 pagesEnglish languagesale 15% off
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.
- Standard10 pagesEnglish languagesale 15% off
This document establishes requirements for reporting the cognitive accessibility of products and technologies, including: Assistive products, Assistive technologies, Consumer technologies, and Household appliances. This document is intended to increase access to a variety of products.
Designers can use this guidance along with any existing standards and accompanying test methods for their products.
- Standard45 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision of the definition about ESSENTIAL PERFORMANCE; b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances; c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V; d) correction of the drop test level from 1,5 m to 1,0 m; e) correction of the wording of IEC 60601-2-66:2015.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard202 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard45 pagesEnglish languagesale 10% offe-Library read for1 day
- Technical specification9 pagesEnglish languagesale 15% off
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.
- Standard76 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard53 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard36 pagesEnglish languagesale 15% off
- Standard39 pagesFrench languagesale 15% off
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.
- Standard40 pagesEnglish languagesale 15% off
- Standard42 pagesFrench languagesale 15% off
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.
- Standard18 pagesEnglish languagesale 15% off
- Standard17 pagesEnglish languagesale 15% off
- Standard22 pagesFrench languagesale 15% off
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.
- Standard81 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60050-872:2022 gives the general terminology used to describe accessibility and terms that writers of standards need when writing and designing International Standards. It has the status of a horizontal publication in accordance with IEC Guide 108. This terminology is consistent with the terminology developed in the other specialized parts of the IEV.
- Standard33 pagesEnglish and French languagesale 15% off
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.
- Standard53 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard76 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard202 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard37 pagesEnglish languagesale 15% off
- Standard40 pagesFrench languagesale 15% off
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.
- Standard54 pagesEnglish languagesale 15% off
- Standard59 pagesFrench languagesale 15% off
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.
- Standard86 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard194 pagesEnglish languagesale 15% off
- Standard202 pagesFrench languagesale 15% off
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 guide 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.
- Technical specification12 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives information on the test methods necessary for the characterization of the physical properties of the most commonly used foams for the manufacture of APTIs.
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
- Technical report21 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides guidance on the mapping of a set of user accessibility needs with the provisions of a particular standard, technical report, or set of guidelines. It provides both basic guidance that should be used for all user accessibility needs mapping and optional guidance that may be added to the basic guidance. User accessibility needs mapping is intended to help improve accessibility for all users and, in particular, for users with special needs that can be overlooked. User accessibility needs mapping is not intended to be used to evaluate or certify a given standard or set of guidelines.
- Standard23 pagesEnglish languagesale 15% off
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.
- Standard8 pagesEnglish languagesale 15% off
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.
- Standard12 pagesEnglish languagesale 15% off
This part of IEC 60118 gives definitions for common hearing aid features such as noise reduction or feedback reduction, etc. Only acoustical inputs are considered. Binaural features are currently not covered in this document. In addition, measurement procedures are described to verify hearing aid features. The objective is not to evaluate the performance of features but to verify their existence and functionality.
Furthermore, definitions and procedures are kept as general as possible so that this document can be applied to various types of hearing aids, e.g. air conduction hearing aids or bone conduction hearing aids. To this end, the general definition for hearing aid of IEC 60118-0:2015 is adopted, and this document does not refer to any specific ear simulator or acoustic coupler but uses a general definition of a coupler. However, if a general view is not applicable or leads to unclear or complex wording, the situation for an air conduction hearing aid is considered, only. Nevertheless, in Clause 4, an explanation is given on how this document can be applied to hearing aids which do not use air conduction.
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Technical report21 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Technical specification12 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard91 pagesEnglish languagesale 15% off
- Standard94 pagesFrench languagesale 15% off
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.
- Technical specification4 pagesEnglish languagesale 15% off
- Technical specification5 pagesFrench languagesale 15% off
This document specifies a range of requirements and recommendations for the elements of construction, building assemblies, components, fittings and products that relate to the design and constructional aspects of usability and accessibility of buildings, i.e. access to buildings, circulation within buildings, egress from buildings during normal conditions, and evacuation in the event of a fire.
This document also applies to the common spaces in multi-unit residential buildings. Recommendations regarding residential units are given in Annex A.
This document also contains provisions with respect to outdoor features directly concerned with access to a building or a group of buildings from a relevant site boundary, or between such a group of buildings within a common site. This document does not deal with elements of the external environment, such as public open spaces, whose function is self-contained and unrelated to the use of a specific building.
This document is applicable to new buildings and new work in existing buildings.
This document introduces the concept of â€exceptional considerations for existing buildings’ for situations where it is exceptionally difficult to meet the requirements specified and, thus, impossible to provide full accessibility. By means of â€exceptional considerations for existing buildings’, an acceptable, though restricted, level of accessibility is specified. An exceptional consideration for existing buildings is not to be applied in other situations or invoked in an unjustified manner, or as an excuse for not achieving a higher level of accessibility, where this is economically and/or technically feasible.
The dimensions stated in this document, relevant to the use of wheelchairs, are related to the footprint of commonly used wheelchair sizes and users as specified in ISOÂ 7176-5 and ISO/TRÂ 13570-2, 800Â mm wide and 1Â 300Â mm long.
This document is primarily written for adults with disabilities, but it includes some recommendations on specific accessibility needs of children.
- Standard177 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard168 pagesEnglish languagesale 15% off
- Standard168 pagesEnglish languagesale 15% off
- Standard178 pagesFrench languagesale 15% off
- Standard178 pagesFrench languagesale 15% off
- Standard – translation177 pagesSlovenian languagesale 10% offe-Library read for1 day
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.
- Standard65 pagesEnglish languagesale 15% off
- Standard69 pagesFrench languagesale 15% off