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Normas DIN – AENOR
DIN EN ISO 80601-2-85:2020-05

DIN EN ISO 80601-2-85:2020-05

Medical electrical equipment - Part 2-85: Particular requirements for basic safety and essential performance of cerebral tissue oximeter equipment (ISO/DIS 80601-2-85:2020); German and English version prEN ISO 80601-2-85:2020 / Note: Date of issue 2020-03-27

/ Attention: Date de parution 2020-03-27

Medizinische elektrische Geräte - Teil 2-85: Besondere Anforderungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten für die zerebrale Oxymetrie (ISO/DIS 80601-2-85:2020); Deutsche und Englische Fassung prEN ISO 80601-2-85:2020 / Achtung: Erscheinungsdatum 2020-03-27

Fecha:
2020-05 /Active
Equivalencias internacionales:

ISO/DIS 80601-2-85 (2020-03)

prEN ISO 80601-2-85 (2020-03)

Resumen:
This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME equipment for those environments of use.
Keywords:
Alarm, Anaesthesiology, Anaesthetic equipment, Analyzers, Applications, Basic safety, Cleaning, Combustible, Compatibility, Components, Connections, Control, Controls, Cords, Definitions, Design, Detail specification, Dielectric strength, Earth conductors, Earthing conductor terminations, 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, Electromedicine, Electrostatics, EMC, Enclosures, Energy, Environmental condition, Environmental conditions, Environmental testing, Equipment safety, Ergonomics, Explosion protection, Fire prevention, Fire risks, Fire safety, Haemoglobin, Handling, Hospital equipment, Human errors, Input current, Inspection, Instructions for use, Interferences, Layout, Limitations, Marking, Measurement, Measuring techniques, Mechanical hazards, Mechanical safety, Medical breathing apparatus, Medical devices, Medical equipment, Medical sciences, Medical technology, Noise, Operation, Oximeters, Oximetry, Oxygen saturation, Patients, Performance, Protection coverings, Protective devices, Radiation, Radiation protection, Safety, Safety engineering, Safety measures, Safety of products, Safety requirements, Sensors, Specification (approval), Stability, System earthing, Temperature, Testing, Thermal hazards, Use, Vapours, Voltage, Working data
183,08
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