This document specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10Â kg.
This document applies to a spirometer that measures timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.
Devices intended for continuously monitoring patients are outside the scope of this document.
NOTE
This document has been prepared to address the relevant essential principles [3] and labelling principles [4] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
(see Clause A.2)
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