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  • BS ISO 17966:2016

    Current The latest, up-to-date edition.

    Assistive products for personal hygiene that support users. Requirements and test methods

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    Published date:  31-01-2016

    Publisher:  British Standards Institution

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    This International Standard specifies requirements and associated test methods for assistive products for personal hygiene (APPHs) that support users and which are intended by the manufacturer to alleviate or compensate for disability. 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 International Standard specifies requirements and test methods for assistive products within the following divisions of ISO9999:2011: 091203 Commode chairs; NOTE This covers mobile and static products. 091206 Toilets with built in raising and height adjustable mechanism; NOTE This excludes toilets with built-in douche and air dryers. 091209 Toilet seats; 091212 Raised toilet seats mounted on frame; 091215 Toilet seats inserts; 091218 Raised toilet seats fixed to toilet; 091221 Toilet seats with built-in raising mechanism to help standing up and sitting down; 091224 Toilet arm supports and toilet back supports mounted on toilet; 091225 Toilet arm supports and toilet back supports, free standing; 091236 Douches and air dryers for attachment to a toilet; 093303 Bath/shower chairs (with and without wheels), bath boards, stools, back supports
    and seats; 093312 Bathing stretchers, shower tables and diaper-changing tables; 181506 Height adjustable plinths and brackets; NOTE Refers to height adjustable plinths and brackets when used as an assistive product for personal hygiene (APPH). Height adjustable mechanisms for other items such as basins may be included. 181803 Handrails and support rails; 181806 Fixed grab bars and handgrips; 181810 Removable grab rails and handgrips; NOTE This excludes removable grab rails and handgrips which are static as defined in 3.27. 181811 Hinged rails and arm supports; This International Standard does not encompass requirements regarding: safe mounting in building structures; requirements regarding fixed building installations e.g. water and electricity; bathtub hoists that are covered by ISO10535; 093321 Bathtubs of ISO9999:2011; stability and friction issues in relation to slippery surfaces due to soap; products that have been customised or custom-made for an individual user.

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    Committee CH/173
    Development Note Supersedes 14/30257546 DC. (04/2016)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61000-4-8 : 2.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
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    ISO 5349-2:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 2: Practical guidance for measurement at the workplace
    IEC 60127:1974 Cartridge fuse-links for miniature fuses
    ISO 21542:2011 Building construction Accessibility and usability of the built environment
    ISO 8191-2:1988 Furniture — Assessment of ignitability of upholstered furniture — Part 2: Ignition source: match-flame equivalent
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 845:2006 Cellular plastics and rubbers — Determination of apparent density
    ISO 13732-1:2006 Ergonomics of the thermal environment — Methods for the assessment of human responses to contact with surfaces — Part 1: Hot surfaces
    EN 716-2:2017 Furniture - Children's cots and folding cots for domestic use - Part 2: Test methods
    IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
    EN 614-1:2006+A1:2009 Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles
    IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment and risk reduction
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 3746:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
    EN 1888:2012 Child care articles - Wheeled child conveyances - Safety requirements and test methods
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 7176-8:2014 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths
    IEC 60601-2-35:1996 Medical electrical equipment - Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use
    IEC 60695-11-10:2013 Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    EN 12530:1998 Castors and wheels - Castors and wheels for manually propelled institutional applications
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    IEC 61000-3-3:2013 RLV Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection
    ISO 2439:2008 Flexible cellular polymeric materials Determination of hardness (indentation technique)
    ISO 2631-1:1997 Mechanical vibration and shock — Evaluation of human exposure to whole-body vibration — Part 1: General requirements
    ISO 9227:2017 Corrosion tests in artificial atmospheres — Salt spray tests
    ISO 7176-11:2012 Wheelchairs — Part 11: Test dummies
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    IEC 61000-3-3 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-3: LIMITS - LIMITATION OF VOLTAGE CHANGES, VOLTAGE FLUCTUATIONS AND FLICKER IN PUBLIC LOW-VOLTAGE SUPPLY SYSTEMS, FOR EQUIPMENT WITH RATED CURRENT <= 16 A PER PHASE AND NOT SUBJECT TO CONDITIONAL CONNECTION
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    EN 12527:1998 Castors and wheels - Test methods and apparatus
    ISO 13850:2015 Safety of machinery Emergency stop function Principles for design
    ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
    ISO 8191-1:1987 Furniture — Assessment of the ignitability of upholstered furniture — Part 1: Ignition source: smouldering cigarette
    ISO 9999:2016 Assistive products for persons with disability Classification and terminology
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 82079-1:2012 Preparation of instructions for use - Structuring, content and presentation - Part 1: General principles and detailed requirements
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 61000-3-2 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE)
    IEC 60730-1:2013+AMD1:2015 CSV Automatic electrical controls - Part 1: General requirements
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