• UNI EN 12182 : 2012

    Current The latest, up-to-date edition.

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

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    Published date:  26-06-2012

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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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 Emitted sound and vibration
    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 a disability produced or
            currently being developed by CEN/TC 293
    Annex B (informative) - General recommendations
    Annex C (informative) - Cognitive impairment
    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 on Medical Devices
    Bibliography

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

    Committee CT 44
    Document Type Test Method
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    UNI 11533 : 2014 MASS-PRODUCED ORTHOPEDIC FOOTWEAR DESIGNED FOR FOOT ORTHOTIC - SAFETY AND PERFORMANCE REQUIREMENTS AND TEST METHODS

    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
    IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    SR 001 996 : 6.1.1 HUMAN FACTORS (HF); AN ANNOTATED BIBLIOGRAPHY OF DOCUMENTS DEALING WITH HUMAN FACTORS AND DISABILITY
    EN 894-3:2000+A1:2008 SAFETY OF MACHINERY - ERGONOMICS REQUIREMENTS FOR THE DESIGN OF DISPLAYS AND CONTROL ACTUATORS - PART 3: CONTROL ACTUATORS
    EN 120 : 1992 WOOD BASED PANELS - DETERMINATION OF FORMALDEHYDE CONTENT - EXTRACTION METHOD CALLED THE PERFORATOR METHOD
    IEC 60127-3:2015 Miniature fuses - Part 3: Sub-miniature fuse-links
    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 (edition 5) Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
    EN 556-1:2001/AC:2006 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES
    IEC 60127-6:2014 Miniature fuses - Part 6: Fuse-holders for miniature fuse-links
    EN 60065:2014/AC:2017-01 AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016)
    CEN/CENELEC GUIDE 6 : 2014 GUIDE FOR ADDRESSING ACCESSIBILITY IN STANDARDS
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 60127-6:2014 MINIATURE FUSES - PART 6: FUSE-HOLDERS FOR MINIATURE FUSE-LINKS (IEC 60127-6:2014)
    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 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 60127-1:2006/A2:2015 MINIATURE FUSES - PART 1: DEFINITIONS FOR MINIATURE FUSES AND GENERAL REQUIREMENTS FOR MINIATURE FUSE-LINKS
    EN 716-2:2017 Furniture - Children's cots and folding cots for domestic use - Part 2: Test methods
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    ISO 24415-2:2011 Tips for assistive products for walking Requirements and test methods Part 2: Durability of tips for crutches
    EN ISO 12952-2 : 2010 TEXTILES - ASSESSMENT OF THE IGNITABILITY OF BEDDING ITEMS - PART 2: IGNITION SOURCE: MATCH-FLAME EQUIVALENT
    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 717-1 : 2004 WOOD-BASED PANELS - DETERMINATION OF FORMALDEHYDE RELEASE - PART 1: FORMALDEHYDE EMISSION BY THE CHAMBER METHOD
    IEC 60127-5:2016 Miniature fuses - Part 5: Guidelines for quality assessment of miniature fuse-links
    EN 60127-3:2015 MINIATURE FUSES - PART 3: SUB-MINIATURE FUSE-LINKS (IEC 60127-3:2015)
    EN 60127-2:2014 Miniature fuses - Part 2: Cartridge fuse-links
    EN ISO 9227:2017 CORROSION TESTS IN ARTIFICIAL ATMOSPHERES - SALT SPRAY TESTS (ISO 9227:2017)
    ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    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)
    IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    EN ISO 5349-2:2001/A1:2015 MECHANICAL VIBRATION - MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO HAND-TRANSMITTED VIBRATION - PART 2: PRACTICAL GUIDANCE FOR MEASUREMENT AT THE WORKPLACE (ISO 5349 2:2001/AMD 1:2015)
    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
    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)
    IEC 60127-2:2014 Miniature fuses - Part 2: Cartridge fuse-links
    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
    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 ISO 22442-1:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015)
    EN ISO 25424:2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    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 (IEC 60601-1-2:2014)
    EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    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 ISO 11137-2:2015 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO 11137-2:2013)
    ISO 12952-2:2010 Textiles Assessment of the ignitability of bedding items Part 2: Ignition source: match-flame equivalent
    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 5349-1 : 2001 MECHANICAL VIBRATION - MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO HAND-TRANSMITTED VIBRATION - PART 1: GENERAL REQUIREMENTS (ISO 5349-1:2001)
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    EN 61000-4-8:2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-8: TESTING AND MEASUREMENT TECHNIQUES - POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST
    EN 62079 : 2001 PREPARATION OF INSTRUCTIONS - STRUCTURING, CONTENT AND PRESENTATION
    EN 597-1:2015 (edition 2) Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 1: Ignition source smouldering cigarette
    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)
    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 ISO 12952-1 : 2010 TEXTILES - ASSESSMENT OF THE IGNITABILITY OF BEDDING ITEMS - PART 1: IGNITION SOURCE: SMOULDERING CIGARETTE
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 12952-1:2010 Textiles Assessment of the ignitability of bedding items Part 1: Ignition source: smouldering cigarette
    IEC 62079:2001 Preparation of instructions - Structuring, content and presentation
    EN 61000-3-2:2014 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 3-2: LIMITS - LIMITS FOR HARMONIC CURRENT EMISSIONS (EQUIPMENT INPUT CURRENT <= 16 A PER PHASE) (IEC 61000-3-2:2014)
    IEC 60127-4:2005+AMD1:2008+AMD2:2012 CSV Miniature fuses - Part 4: Universal modular fuse-links (UMF) -Through-hole and surface mount types
    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 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
    ISO 9227:2017 Corrosion tests in artificial atmospheres — Salt spray tests
    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
    ISO 13850:2015 Safety of machinery Emergency stop function Principles for design
    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
    ISO 9999:2016 Assistive products for persons with disability Classification and terminology
    EN 597-2:2015 (edition 2) Furniture - Assessment of the ignitability of mattresses and upholstered bed bases - Part 2: Ignition source: match flame equivalent
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    EN 80601-2-35:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)
    ISO 24415-1:2009 Tips for assistive products for walking Requirements and test methods Part 1: Friction of tips
    EN 60068-2-32 : 1993 BASIC ENVIRONMENTAL TESTING PROCEDURES - PART 2: TESTS - TEST ED: FREE FALL
    EN ISO 24415-1 : 2009 TIPS FOR ASSISTIVE PRODUCTS FOR WALKING - REQUIREMENTS AND TEST METHODS - PART 1: FRICTION OF TIPS
    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 60127-5:2017 MINIATURE FUSES - PART 5: GUIDELINES FOR QUALITY ASSESSMENT OF MINIATURE FUSE-LINKS (IEC 60127-5:2016)
    EN 60127-4:2005/A2:2013 Miniature fuses - Part 4: Universal modular fuse-links (UMF) - Through-hole and surface mount types
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    EN 980 : 2008 SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
    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)
    EN 60730-1:2016 AUTOMATIC ELECTRICAL CONTROLS - PART 1: GENERAL REQUIREMENTS (IEC 60730-1:2013, MODIFIED + COR1:2014)
    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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