DIN EN ISO 80601-2-70:2021-06
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020); German version EN ISO 80601-2-70:2020 / Note: To be replaced by DIN EN ISO 80601-2-70 (2025-02).
| Fecha edición: |
2021-06-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This particular standard is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.This particular standard excludes sleep apnoea breathing therapy equipment intended for use with neonates.This particular standard is applicable to me equipment or an ME system intended for those patients who are not dependent on mechanical ventilation such as patients with central sleep apnoea.This particular standard is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. |
| Keywords: | Apnoea|Breathing apparatus|Breathing equipment|Breathing therapy|Definitions|Electrical appliances|Electrical medical equipment|Electrical safety|Environmental conditions|Features|Hazards|Inhaled air|Marking|Medical devices|Medical equipment|Medical technology|Radiation|Respiratory standstill|Safety requirements|Sleep|Snore illness|Specification (approval)|Testing|Therapeutics|Therapy equipment |
| ICS: | 11.040.10 - Equipo de respiración, anestesia y reanimación |
| CTN: | |
|
Equivalencia Internacional |
Idéntica EN ISO 80601-2-70:2020 Idéntica ISO 80601-2-70:2020 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 17510-1:2009-07 Reemplaza a DIN EN ISO 80601-2-70:2019-10 |
Normas citadas
Libros relacionados
Normas relacionadas
Colecciones temáticas relacionadas
