DIN EN ISO 80601-2-80:2025-02
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024); German version EN ISO 80601-2-80:2024
| Fecha edición: |
2025-02-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories: - intended for use in the home healthcare environment; - intended for use by a lay operator; - intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; - intended for transit-operable use; - not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601?1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601?1:2005+AMD1:2012, 4.2. This document does not specify the requirements for: - ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601?2?12; - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601?2?13[5]; - ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601?2?84[6][1], the future replacement for ISO 10651?3[7]; - ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601?2?72; - ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601?2?79[1]; - sleep apnoea therapy me equipment, which are given in ISO 80601?2?70[8]; - continuous positive airway pressure (CPAP) me equipment; - high-frequency jet ventilators (HFJVs); - high-frequency oscillatory ventilators (HFOVs)[9]; - oxygen therapy constant flow me equipment; - cuirass or "iron-lung" ventilation equipment. This document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of documents. [1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017. |
| Keywords: | Accessories|Alarm|Alpha radiation|Ambulance services|Assembling|Bags|Beta radiation|Biocompatibility|Bodies|Breathing|Breathing apparatus|Breathing equipment|Changing|Clamps|Classification|Cleaning|Compatibility|Conditions|Connections|Continuous current|Control instruments|Corners|Covers|Defects|Definitions|Design|Dielectric strength|Disability|Discharge|Disinfection|Earth conductors|Earthing conductor terminations|Edge|Electric power systems|Electrical engineering|Electrical equipment|Electrical hazards|Electrical medical equipment|Electrical safety|Electromagnetic compatibility|Electrostatics|EMC|Emergency equipment|Enclosures|Energy|Energy supply|Environmental conditions|Environmental testing|Equipment|Equipment safety|Fail|Failure|Features|Fire prevention|Fire risks|Flexible pipes|Flows|Gamma-radiation|Handling|Heat exchangers|Home healthcare environment|Home use|Homes|Hospitals|Household use|Humectants|Infrared radiation|Input current|Inspection|Instructions for use|Intensive care equipment|Laser beams|Layout|Limitations|Liquids|Luminous radiation|Lung ventilators|Lungs|Marking|Mass|Measurement|Measuring instruments|Mechanics|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Microwave radiation|Moisture|Neutron radiation|Noise|Nursing|Outlets|Overflows|Oxygen|Paper|Patient auxiliary current|Performance|Performances|Pneumatics|Potential equalization|Power consumption|Power transmission systems|Precision|Pressure|Pressure vessels|Protection|Protection against electric shocks|Protection coverings|Protective devices|Pulmonary affection|Radiation|Radiation protection|Rescue and ambulance services|Respiration|Respirators|Respired gases|Safety|Safety engineering|Safety of products|Safety requirements|Separation|Sound energy|Specification|Specification (approval)|Stability|Sterilization (hygiene)|Strength of materials|Substances|Surfaces|System earthing|Temperature|Testing|Ultrasonics|Ultraviolet radiation|Use|Ventilators|Vibrations|Working data|X-rays |
| ICS: | 11.040.10 - Equipo de respiración, anestesia y reanimación |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 80601-2-80:2024 Idéntica ISO 80601-2-80:2024 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 80601-2-80:2020-02 Reemplaza a DIN EN ISO 80601-2-80:2023-07 |
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