Norm

NEN-EN-ISO 17510-1:2005 Ontw. en

Slaap-apneutherapie - Deel 1: Apparatuur voor slaap-apneutherapie

  • Deze norm is ingetrokken sinds 15-10-2007

38,91

Over deze norm

Status Ingetrokken
Aantal pagina's 40
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-11-2005
Taal Engels
This document specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft, and other transport vehicles and for use in healthcare institutions. This document applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates. Jet and very high frequency ventilation and oscillation are not considered in this part of this document. This document does not apply to equipment covered by the scope of the ISO 10651 series, including: - ISO 10651-2:2005, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator dependent patients; - ISO 10651-3:1997, Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators; - ISO 10651-4:2002, Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators. - ISO 10651-5:2005, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators; and - ISO 10651-6:2005, Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices. This document does not cover equipment covered by the scope of IEC 60601-2-12:2001, Medical electrical equipment - Part 2-12, Particular requirements for the safety of lung ventilators - Critical care ventilators. Masks and application accessories, including any breathing tubes are addressed in Part 2 of this document.

Details

ICS-code 11.040.10
Nederlandse titel Slaap-apneutherapie - Deel 1: Apparatuur voor slaap-apneutherapie
Engelse titel Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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