• DIN EN 12182:2012-07

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Superseded date:  26-11-2022

    Language(s):  German, English

    Published date:  01-07-2012

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    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
    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
    IEC 61000-4-8:2009 Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test
    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
    ISO 11137-2:2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
    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
    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
    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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