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  • PREN 12182 : 2009-06

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS

    Available format(s): 

    Superseded date:  01-05-2012

    Language(s): 

    Published date:  01-06-2009

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Materials
    6 Noise, vibration and sound
    7 Electromagnetic compatibility
    8 Electrical safety
    9 Overflow, spillage, leakage, and ingress of liquids
    10 Surface temperature
    11 Sterility
    12 Safety of moving parts
    13 Prevention of traps for parts of the human body
    14 Folding and adjusting mechanisms
    15 Carrying handles
    16 Assistive products which support or suspend users
    17 Portable and mobile assistive products
    18 Surfaces, corners, edges and protruding parts
    19 Hand held assistive products
    20 Small parts
    21 Stability
    22 Forces in soft tissues of the human body
    23 Ergonomic principles
    24 Requirements for information supplied by the manufacturer
    25 Packaging
    26 Test report
    Annex A (informative) European standards for assistive products
            for persons with disability produced or currently being
            developed by CEN/TC 293
    Annex B (informative) General recommendations
    Annex C (normative) Ergonomics and cognition
    Annex D (informative) Environmental and consumer related
            requirements
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU Directive
             93/42/EEC Medical Devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines general requirements and test methods for assistive products for persons with disabilities.

    General Product Information - (Show below) - (Hide below)

    Comment Closes On
    Committee TC 293
    Document Type Draft
    Publisher Comite Europeen de Normalisation
    Status Superseded

    National Adoptions - (Show below) - (Hide below)

    Equivalent Standard(s) Relationship
    09/30201992 DC : 0 Identical

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

    EN ISO 22523 : 2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
    EN 894-3:2000+A1:2008 Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 3: Control actuators
    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
    EN ISO 9999:2016 Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
    EN ISO 8670-2 : 1996 Ostomy collection bags - Part 2: Requirements and test methods (ISO 8670-2:1996)
    EN ISO 16021:2000 Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers (ISO 16021:2000)
    EN ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
    EN 60065:2014/AC:2017-01 AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016)
    EN ISO 11334-1:2007 Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches (ISO 11334-1:2007)
    EN 60127-6:2014 Miniature fuses - Part 6: Fuse-holders for miniature fuse-links
    EN 61000-3-3:2013 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 (IEC 61000-3-3:2013)
    EN 716-2:2017 Furniture - Children's cots and folding cots for domestic use - Part 2: Test methods
    EN ISO 12952-2:2010 Textiles - Assessment of the ignitability of bedding items - Part 2: Ignition source: match-flame equivalent (ISO 12952-2:2010)
    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    EN ISO 11199-1:1999 WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 1: WALKING FRAMES
    EN 1021-1:2014 FURNITURE - ASSESSMENT OF THE IGNITABILITY OF UPHOLSTERED FURNITURE - PART 1: IGNITION SOURCE SMOULDERING CIGARETTE
    EN 60950-1:2006/A2:2013 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED)
    EN ISO 13850:2015 Safety of machinery - Emergency stop function - Principles for design (ISO 13850:2015)
    EN ISO 11334-4 : 1999 WALKING AIDS MANIPULATED BY ONE ARM - REQUIREMENTS AND TEST METHODS - WALKING STICKS WITH THREE OR MORE LEGS
    EN ISO 9227:2017 Corrosion tests in artificial atmospheres - Salt spray tests (ISO 9227:2017)
    EN 614-1:2006+A1:2009 Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    EN 12182:2012 Assistive products for persons with disability - General requirements and test methods
    EN ISO 11199-3 : 2005 WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
    EN 1985 : 1998 WALKING AIDS - GENERAL REQUIREMENTS AND TEST METHODS
    EN ISO 13732-1:2008 Ergonomics of the thermal environment - Methods for the assessment of human responses to contact with surfaces - Part 1: Hot surfaces (ISO 13732-1:2006)
    EN 61000-4-3 : 2006 AMD 2 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    EN 60601-1-2:2015 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
    EN ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
    EN ISO 12952-4 : 1998 TEXTILES - BURNING BEHAVIOUR OF BEDDING ITEMS - PART 4: SPECIFIC TEST METHODS FOR THE IGNITABILITY BY A SMALL OPEN FLAME
    EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    EN 12184:2014 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
    EN 60601-2-35:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use
    EN 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 (ISO 3746:2010)
    EN 1888:2012 Child care articles - Wheeled child conveyances - Safety requirements and test methods
    EN ISO 10535:2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)
    EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
    EN 61000-4-8:2010 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
    EN 597-1:2015 Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source smouldering cigarette
    EN ISO 11199-2:2005 Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2005)
    EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
    EN ISO 12952-1:2010 Textiles - Assessment of the ignitability of bedding items - Part 1: Ignition source: smouldering cigarette (ISO 12952-1:2010)
    EN 61000-3-2:2014 Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)
    EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
    EN ISO 8669-2 : 1996 URINE COLLECTION BAGS - PART 2: REQUIREMENTS AND TEST METHODS
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 2631-1:1997 Mechanical vibration and shock — Evaluation of human exposure to whole-body vibration — Part 1: General requirements
    EN 1970:2000/A1:2005 ADJUSTABLE BEDS FOR DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
    CISPR 11:2015 RLV Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement
    EN 60335-1:2012/A13:2017 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60335-1:2010, MODIFIED)
    ISO 5349-1:2001 Mechanical vibration Measurement and evaluation of human exposure to hand-transmitted vibration Part 1: General requirements
    EN ISO 12952-3 : 1998 TEXTILES - BURNING BEHAVIOUR OF BEDDING ITEMS - PART 3: GENERAL TEST METHODS FOR THE IGNITABILITY BY A SMALL OPEN FLAME
    EN 597-2:2015 Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 2: Ignition source: match flame equivalent
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    EN 60068-2-32:1993 Basic environmental testing procedures - Part 2: Tests - Test Ed: Free fall
    EN ISO 14184-1:2011 Textiles - Determination of formaldehyde - Part 1: Free and hydrolysed formaldehyde (water extraction method) (ISO 14184-1:2011)
    EN 60601-1-9:2008/A1:2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1-9: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR ENVIRONMENTALLY CONSCIOUS DESIGN (IEC 60601-1-9:2007/A1:2013)
    EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
    EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
    EN 1021-2:2014 Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    IEC 60730-1:2013+AMD1:2015 CSV Automatic electrical controls - Part 1: General requirements
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