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ASTM F 1690 Document Information:
Title
Standard Specification for Humidifiers for Medical Use - Part 1: General Requirements for Active Humidification Systems
ASTM International
Publication Date:
Jan 1, 1996
Scope:
The requirements given in Clause 1 of the General Standard apply with
the following additions and
modifications:
Replace 1.1 with the following:
This specification includes requirements for the safety and
performance of active vaporizing and
nebulizing humidification systems, as defined in 3.63.1.6, suitable
for inclusion in breathing
systems (both intubated and non-intubated patients).
This specification also includes requirements for breathing tubes,
including heated breathing tubes
(heated-wire breathing circuits), and devices intended to control
these heated breathing tubes,
heated breathing tube controllers.
Heat and moisture exchangers (HMEs) are outside the scope of this
specification. However, it is
recognized that their safety and performance may affect that of
humidification systems. Numerous
studies have been published citing the benefits and risks of HMEs used
in conjunction with
humidification systems. It is advisable to review the instructions for
use provided with the
humidification systems and HMEs and the available literature for more
details.
Devices commonly referred to as "room humidifiers," humidifiers used
in heating, ventilation, and
air-conditioning systems and humidifiers used to condition the
environment within infant incubators
are outside the scope of this specification.
It has not been found possible to include guidance on the matter of
droplet size in the case of
nebulizing humidifiers.
Gas-powered nebulizers used for the delivery of drugs to patients
through their respiratory system
are outside the scope of this specification.
Appendices in this specification are not mandatory unless made so by
an explicit statement in the
main text.
The values stated in SI units are to be regarded as the standard.
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