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Ergonomic standard
  • Document number:
    ISO/FDIS 80601-2-12
  • Issuing date:
  • Document type:
  • Title:
    Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
  • Replaces:
    ISO/DIS 80601-2-12(2021-08)
  • Author:
    ISO/TC 121 Anaesthetic and respiratory equipment
  • Search term:
    Accident prevention; Adjustments; Air supply; Alarm; Alpha radiation; Artificial respiration; Assembling; Bags; Beta radiation; Biocompatibility; Bodies; Breathing; Breathing apparatus; Breathing equipment; Chargings; Clamps; Classes; Cleaning; Compatibility; Compensation (errors); Components; Connections; Continuous current; Control instruments; Corners; Covers; Critical care; Decontaminations; Defects; Definitions; Design; Dielectric strength; Discharge; Disinfection; Distant transmission; Earth conductors; Earthing; Earthing conductor terminations; Edge; Electric power systems; Electric shock; Electrical accidents; Electrical engineering; Electrical hazards; Electrical medical equipment; Electrical safety; Electromagnetism; Electromedicine; Electrostatics; EMC; Enclosures; Energy; Environmental conditions; Environmental testing; Equipment; Equipment safety; Failure; Filters; Fire prevention; Fire risks; Flexible pipes; Gamma-radiation; Handling; Heat exchange; Humectants; Hydraulics; Infrared radiation; Input current; Inspection; Instructions for use; Instruments; Intensive care equipment; Intensive-care ward; Interruptions; Jigs; Laser radiation; Layout; Leakage; Legibility; Limitations; Liquids; Luminous radiation; Lung ventilators; Marking; Mass; Measuring instruments; Mechanical hazards; Mechanical safety; Mechanics; Medical breathing apparatus; Medical devices; Medical equipment; Medical sciences; Medical technology; Microbes; Microwave radiation; Moisture; Neutron radiation; Noise; Nursing; Occupational safety; Operation; Outlets; Overflows; Oxygen; Oxygen supply; Packages; Paper; Part of a device; Patient auxiliary current; Pneumatics; Potential equalization; Power consumption; Power transmission systems; Precision; Pressure; Pressure releases; Pressure vessels; Protection; Protection against electric shocks; Protection coverings; Protective devices; Radiation protection; Resistors; Respiration; Respirators; Safety; Safety engineering; Safety of products; Safety requirements; Separation; Signals; Sound energy; Specification (approval); Stability; Sterilization (hygiene); Strength of materials; Stress; Substances; Surfaces; System earthing; Temperature; Tensile force; Testing; Testing conditions; Thermal hazards; Ultrasonics; Ultraviolet radiation; Use; Vibrations; Visibility; Volume; Warnings; Working data; Workplace safety; X-rays
  • Application areas:
    09.05 Medizinische Geräte und Instrumente; 09.10 Medizinische Produkte
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; AD Folgen von Belastungen und Gefährdungen (z. B. Ermüden, Ersticken, Ertrinken); BB Mikroorganismen (Viren, Bakterien, Parasiten u. Ä.); GF Optische Strahlungen (infrarote Strahlung, ultraviolette Strahlung, Laserstrahlungen); GI Ionisierende Strahlungen (Röntgenstrahlungen, radioaktive Strahlung / Alpha-, Beta- und Gamma-Strahlung); HD Handhabungsfaktoren (Gestaltung und Anordnung von Bedienelementen, Bewegungsraum, Gestaltung und Handhabbarkeit von Arbeitsmitteln, Sichtfeld, Standsicherheit)
  • ICS:
    11.040.10 Anaesthetic, respiratory and reanimation equipment
  • Price:
    260,70 EUR
  • Identical with:
    FprEN ISO 80601-2-12(2022-10)<IDT>; FprEN ISO 80601-2-12(2023-06)<IDT>; IEC 62D/1994/FDIS(2022-10)<IDT>
  • Update flag: