Norm

ISO/DIS 20789:2016 en

Anaesthetic and respiratory equipment - Passive humidifiers

  • Deze norm is niet direct leverbaar vanuit de NEN-shop.
    Wilt u dit product bestellen neemt u dan contact op met NEN-klantenservice: (015) 2 690 391 of klantenservice@nen.nl

Over deze norm

Status Ontwerp
Aantal pagina's 53
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-09-2016
Taal Engels
This document specifies requirements for passive or so-called ‘cold bubble-through’ or ‘cold pass-over’ humidifying equipment, hereafter referred to as a passive HUMIDIFIER. Passive HUMIDIFIERS add water in the form of droplets or vapour, or both, to the inspired gas, without the use of heat. That is, passive HUMIDIFIERS do not utilise electricity to increase the temperature of either the water chamber or the circuit tubing. Passive HUMIDIFIER water chambers are at room temperature so have a lower mg/l output than  active HUMIDIFIERS. Figure 1 and Figure 2 illustrate these HUMIDIFIERS. This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a passive HUMIDIFIER. The HUMIDIFICATION OUTPUT of passive or so called ‘cold bubble-through’ or ‘cold pass-over’ passive HUMIDIFIERS is less than active HUMIDIFIERS and hence does not generally meet the clinical requirements when invasive ventilation (in which the upper airway is bypassed) is used. This document does not specify the requirements for active heated HUMIDIFIERS, heated BREATHING TUBES, or active heat and moisture exchanger (HME), the requirements for which are given in ISO 80601-2-74 [3]. A passive HUMIDIFIER can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the passive HUMIDIFIER. EXAMPLE 1 A passive HUMIDIFIER incorporated into an oxygen concentrator where ISO 80601-2-69 [5] also applies. EXAMPLE 2 A passive HUMIDIFIER incorporated into sleep apnoea therapy equipment where ISO 80601-2-70 [6] also applies. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the PATIENT to the respiratory tract during inspiration without adding heat or moisture, the requirements for which are given in ISO 9360-1 [7] and ISO 9360-2 [8]. This document is not applicable to nebulizers used for the delivery of liquids to PATIENTS, the requirements for which are given in ISO 27427 [9]. This document is not applicable to equipment commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.

Details

ICS-code 11.040.10
Nederlandse titel Anaesthetic and respiratory equipment - Passive humidifiers
Engelse titel Anaesthetic and respiratory equipment - Passive humidifiers

Winkelwagen

Subtotaal:

Ga naar winkelwagen