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Ergonomic standard
  • Abstract:
    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.
  • Document number:
    DIN EN ISO 21856
  • Issuing date:
    2020-05-01
  • Document type:
    Norm-Entwurf
  • Title:
    Assistive products - General requirements and test methods (ISO/DIS 21856:2020); German and English version prEN ISO 21856:2020
  • Author:
    Rescue Services and Hospital Standards Committee
  • Search term:
    Accessible; Accessories; Adapted designing for disabled persons; Adjusting elements; Aids; Aids for the disabled; Attrition; Bedding; Braking system; CE marking; Chemicals; Classification; Cleaning; Communication; Communication media; Compatibility; Contamination; Control systems; Corrosion resistance; Danger of infection; Dangerous materials; Data of the manufacturer; Definitions; Design; Disability; Disabled people; Efficiency; Electric blankets; Electrical safety; Electromagnetic compatibility; Electronic equipment; EMC; Emergency-off; Environment; Ergonomics; Fasteners; Fitness for purpose; Flammability; Folding behaviour; Functionality; Handicapped people; Handicapped persons; Household use; Information systems; Injection moulding parts; Instructions for use; Liquids; Load limit; Marking; Material selection; Materials; Mattresses; Mechanical crimping; Mechanical properties; Medical devices; Medical sciences; Mentally-handicapped people; Monitoring systems; Remote control; Resistance; Risk analysis; Safety; Safety requirements; Sound; Specification (approval); Stability; Sterility; Sterilization (hygiene); Suitable for handicapped persons; Surface temperatures; Technical aid; Temperature; Testing; Transportation of handicapped persons; User information; User interface; Vibration; Warning devices
  • Application areas:
    01.01 Technische Arbeitsmittel im Allgemeinen; 02.01 Werkzeuge im Allgemeinen; 36.10 Biomechanik
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; BA Biologische Gefährdungen im Allgemeinen; DB Quetschen, Einklemmen; FB Brandgefährdungen; HD Handhabungsfaktoren (Gestaltung und Anordnung von Bedienelementen, Bewegungsraum, Gestaltung und Handhabbarkeit von Arbeitsmitteln, Sichtfeld, Standsicherheit); KF Belastungen durch Störungen, Ausfall und Fehlen von Sicherheitseinrichtungen
  • ICS:
    11.180.01 Aids for disabled and handicapped persons in general
  • Price:
    176,80 EUR
  • Identical with:
    prEN ISO 21856(2020-03)<IDT>; ISO/DIS 21856(2020-03)<IDT>
  • Update flag:
    Unchanged
  • Deadline for comments:
    2020-05-27