DIN EN ISO 80601-2-61:2019-09
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017, Corrected version 2018-02); German version EN ISO 80601-2-61:2019 / Note: To be replaced by DIN EN ISO 80601-2-61 (2025-01).
| Fecha edición: |
2019-09-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This part of the standard series describes safety requirements for pulse oximeter intended for use on humans. This includes pulse oximeter monitor, pulse oximeter probe and probe cable extender. |
| Keywords: | Alarm|Alpha radiation|Anaesthetic equipment|Assembling|Beta radiation|Biocompatibility|Blood counts|Bodies|Breathing equipment|Chargings|Chemical analysis and testing|Clamps|Cleaning|Compatibility|Components|Connections|Continuous current|Corners|Covers|Defects|Definitions|Determinations|Dielectric strength|Discharge|Disinfection|Earth conductors|Earthing conductor terminations|Edge|Electric power systems|Electrical|Electrical engineering|Electrical hazards|Electrical medical equipment|Electrical safety|Electromagnetic compatibility|Electromedicine|Electrostatics|EMC|Enclosures|Energy|Environmental conditions|Environmental testing|Equipment safety|Extension cables|Features|Fire prevention|Gamma-radiation|Haemoglobin|Haemoglobin content|Human errors|Hydraulics|Infrared radiation|Input current|Interruptions|Laser beams|Layout|Limitations|Liquids|Luminous radiation|Mass|Measuring instruments|Mechanical hazards|Mechanics|Medical devices|Medical equipment|Medical sciences|Medical technology|Moisture|Monitors|Neutron radiation|Noise|Outlets|Overflows|Oximeters|Oximetry|Oxygen saturation|Paper|Patient auxiliary current|Performance requirements|Pneumatics|Potential equalization|Power consumption|Precision|Pressure|Pressure vessels|Protection against electric shocks|Protection coverings|Protective devices|Protective measures|Pulse|Pulse oximeters|Radiation protection|Safety|Safety engineering|Safety of products|Safety requirements|Saturation|Sensors|Separation|Signals|Sound energy|Specification (approval)|Stability|Sterilization (hygiene)|Strength of materials|Stress|Surfaces|System earthing|Temperature|Testing|Thermal hazards|Ultrasonics|Ultraviolet radiation|Use|Vibrations|Working data|X-rays |
| ICS: | 11.040.55 - Equipo de diagnóstico |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 80601-2-61:2019 Idéntica ISO 80601-2-61:2017 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 80601-2-61:2012-01;VDE 0750-2-61:2012-01 Reemplaza a DIN EN ISO 80601-2-61:2016-12 |










