DIN EN ISO 80601-2-55:2024-07
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018 + Amd 1:2023); German version EN ISO 80601-2-55:2018 + A1:2023
| Fecha edición: |
2024-07-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | 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. |
| Keywords: | Accident prevention|Adjusters|Alarm|Alpha radiation|Anaesthesiology|Anaesthetic equipment|Analyzers|Applications|Assembling|Basic safety|Beta radiation|Biocompatibility|Breathing apparatus|Breathing equipment|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|Definitions|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 |
| ICS: | 11.040.10 - Equipo de respiración, anestesia y reanimación |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 80601-2-55:2018/A1:2023 Idéntica ISO 80601-2-55:2018/Amd 1:2023 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 80601-2-55:2019-03 Reemplaza a DIN EN ISO 80601-2-55/A1:2023-03 |
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