Overview

The standard applies to spirometers for measuring peak expiratory flow in spontaneously breathing humans. It covers not only hand-held devices, but also spirometers that are integrated into other devices for measuring lung function. It sets out requirements for the safety and performance of spirometers for measuring peak expiratory flow. These include in particular specifications on measurement error, linearity and repeatability, flow resistance and frequency response. The performance requirements shall be met even after the spirometer has been disassembled and then reassembled and after a defined number of measurements have been carried out. Compared to the July 2010 edition, the requirements for labelling and instructions for use, the drop test and the equation for calculating the effects of disassembly, ageing and falling have been revised in particular. The International Standard has been prepared by ISO/TC 121/SC 3 "Lung ventilators and related equipment" (secretariat: ANSI, USA) in collaboration with CEN/TC 215 "Respiratory and anaesthetic equipment" (secretariat: BSI, United Kingdom). The responsible national committee is Working Committee NA 053-03-01 AA "Anästhesie und Beatmung" ("Anaesthesia and artificial respiration") at DIN Standards Committee Rescue Services and Hospital (NARK).

Document: references other documents

Responsible national committee

NA 176-05-03 AA - Anaesthesia and artificial respiration  

Responsible european committee

CEN/TC 215/WG 2 - Lung ventilators and related equipment  

Responsible international committee

ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care