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  • Abstract:
    This document specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous use with a patient. This amendment updates the references to the IEC 60601-1 series of standards specified throughout this document. This amendment also: a) reinstates Oxygen 21,0 % as a balance gas level in Table 210.103 which, it appears, was deleted in error; b) amends the text regarding drift and accuracy of measurement; c) allows a risk management approach to the prevention of cross infection for RGMs that return sampled gas to the breathing system; d) adds rationale for the typical level or argon that can be found in gas supplied by concentrators.
  • Document number:
    DIN EN ISO 80601-2-55/A1
  • Issuing date:
  • Document type:
  • Title:
    Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/DAM 1:2023); German and English version EN ISO 80601-2-55:2018/prA1:2023
  • Author:
    Rescue Services and Hospital Standards Committee
  • Search term:
    Accident prevention; Adjusters; Alarm; Alpha radiation; Anaesthesiology; Anaesthetic equipment; Analyzers; Applications; Assembling; Basic safety; Beta radiation; Biocompatibility; Breathing apparatus; Capnometers; Carbon dioxide; CE marking; Chargings; Clamps; Classification; Classification systems; Cleaning; Closures; Combustible; Compatibility; Components; Concentration; Condensation; Conduits; Conglomerates; Connections; Contact; Continuous current; Control; Control instruments; Controls; Corners; Covers; Defects; Design; Detail specification; Determinations; Diagnostic equipment; Dielectric strength; Discharge; Disinfection; Drift; Earth conductors; Earthing conductor terminations; Edge; Electric appliances; Electric power systems; Electric shock; Electrical; Electrical appliances; Electrical engineering; Electrical hazards; Electrical medical equipment; Electrical protection equipment; Electrical safety; Electromagnetic compatibility; Electromagnetic hazards; Electromagnetic interferences; Electromedicine; Electrostatics; EMC; Enclosures; Energy; Environmental condition; Environmental conditions; Environmental testing; Equipment safety; Ergonomics; Exhaust gases; Explosion protection; Features; Fire prevention; Fire risks; Fire safety; Gamma-radiation; Gas analysis; Gas measuring instruments; Gas mixtures; Gases; Handling; Hospital equipment; Human errors; Hydraulics; Ignition; Impurities; Indications; Infrared radiation; Inhalation; Input current; Inscription; Inspection; Instructions for use; Instruments; Interferences; Interruptions; Laser beams; Layout; Leakage; Letterings; Limitations; Liquids; Luminous radiation; Marking; Mass; Materials; Measurement; Measuring accuracy; Measuring instruments; Measuring techniques; Mechanical hazards; Mechanical safety; Medical breathing apparatus; Medical devices; Medical equipment; Medical gases; Medical science; Medical sciences; Medical technology; Microwave radiation; Moisture; Monitoring device; Monitoring systems; Neutron radiation; Noise; Operation; Overflows; Oxygen; Oxygen breathing apparatus; Oxygen concentration; Oxygen content; Paper; Partial pressures; Patient auxiliary current; Patients; People; Pneumatics; Potential equalization; Power consumption; Precision; Pressure; Pressure vessels; Protection; Protection against electric shocks; Protection coverings; Protective devices; Radiation; Radiation protection; Rescue and ambulance services; Respiration; Respiratory system; Respired gases; Safety; Safety engineering; Safety measures; Safety of products; Safety requirements; Samples; Sensors; Separation; Sequence of operations; Signals; Sound; Sound energy; Sound pressure level; Spark; Specification (approval); Stability; Steam; Sterilization (hygiene); Strength of materials; Surfaces; Surgery; Surgical instruments; Surveillance (approval); System earthing; Temperature; Testing; Thermal hazards; Ultrasonics; Ultraviolet radiation; Use; Vapours; Vibrations; Voltage; Working data; X-rays
  • Application areas:
    09.05 Medizinische Geräte und Instrumente; 09.10 Medizinische Produkte
  • Hazards:
    BB Mikroorganismen (Viren, Bakterien, Parasiten u. Ä.); EB Berühren spannungsführender oder leitfähiger Teile; FB Brandgefährdungen; GC Schall (Lärm); 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); KF Belastungen durch Störungen, Ausfall und Fehlen von Sicherheitseinrichtungen
  • ICS:
    11.040.10 Anaesthetic, respiratory and reanimation equipment
  • Price:
    57,10 EUR
  • Identical with:
    EN ISO 80601-2-55/prA1(2023-02)<IDT>; ISO 80601-2-55 DAM 1(2023-02)<IDT>
  • Update flag:
  • Deadline for comments: