Norm

NEN-EN-ISO 8185:2004 Ontw. en

Luchtademhalingkanaal voor medisch gebruik - Bijzondere eisen voor ademhalingsbevochtigingssystemen

  • Deze norm is ingetrokken sinds 18-07-2007

38,91

Over deze norm

Status Ingetrokken
Aantal pagina's 51
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-04-2004
Taal Engels
This International Standard includes requirements for the safety and performance of humidifiers, as defined in 3.7, suitable for inclusion in breathing systems. This International Standard also includes requirements for breathing tubes, including heated breathing tubes (heated-wire breathing tubes), and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes. Respiratory Tract Humidifiers can be gas-powered, electrically-powered, or both. However, this International Standard has been prepared as a Particular Standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. Where this International Standard specifies that a clause of IEC 60601-1 applies, it means that the clause applies only if the requirement is relevant to the humidification system under consideration. This International Standard also includes requirements for active HME (heat and moisture exchangers) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. ISO 9360 specifies other safety and performance requirements for an HME and describes methods for testing performance. This International Standard is not applicable to a passive HME, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without additional sources of heat and moisture. This International Standard is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. This International Standard is not applicable to nebulizers used for the delivery of drugs to patients.

Details

ICS-code 11.040.10
Nederlandse titel Luchtademhalingkanaal voor medisch gebruik - Bijzondere eisen voor ademhalingsbevochtigingssystemen
Engelse titel Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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