prEN ISO 26782 rev

Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans

General information

10.99 New project approved   Aug 31, 2024

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

Scope

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.

Related legislation

Legislation related to this standard

2017/745

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

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 26782:2009

PUBLISHED
EN ISO 26782:2009/AC:2009

NOW

IN_DEVELOPMENT
prEN ISO 26782 rev
10.99 New project approved
Aug 31, 2024