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BS EN ISO 26782 ISO 26782 Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans

Source:
ISO
Committee:
CH/121 - Anaesthetic and respiratory equipment
Categories:
Anaesthetic, respiratory and reanimation equipment
Comment period start date:
Comment period end date:
Number of comments:
0

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Scope

This document specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 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.

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