ISO 26782:2009 specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg.
ISO 26782:2009 applies to spirometers that measure 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.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
PROJECT
nkSRPS EN ISO 26782:2024
30.99
CD approved for registration as DIS
Aug 28, 2026