Anaesthetic and respiratory equipment – Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
Abstract
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.
DIN EN ISO 26782:2010-02 (E)
Anaesthetic and respiratory equipment – Spirometers intended for the measurement
of time forced expired volumes in humans (ISO 26782:2009 + Cor. 1:2009) (includes
Corrigendum AC:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General requirements ……………………………………………………………………………………………………..8
4.1 Electrical safety ………………………………………………………………………………………………………………8
4.2 Mechanical safety ……………………………………………………………………………………………………………8
5 Identification, marking and documents ……………………………………………………………………………8
5.1 Marking of the scale or display ………………………………………………………………………………………..8
5.2 Legibility of markings ……………………………………………………………………………………………………..9
5.3 Durability of markings …………………………………………………………………………………………………….9
5.4 Marking of the spirometer or its packaging ……………………………………………………………………10
5.5 Instructions for use ……………………………………………………………………………………………………….10
5.6 Technical description ……………………………………………………………………………………………………12
6 Measurement range ………………………………………………………………………………………………………12
7 Performance requirements ……………………………………………………………………………………………12
7.1 Accuracy ………………………………………………………………………………………………………………………12
7.2 Recording time ……………………………………………………………………………………………………………..13
7.3 Graphical display aspect ratios ……………………………………………………………………………………..13
7.4 Volume recording ………………………………………………………………………………………………………….13
7.5 Start of forced exhalation ………………………………………………………………………………………………13
7.6 End of forced exhalation ……………………………………………………………………………………………….13
7.7 Linearity ……………………………………………………………………………………………………………………….13
7.8 Repeatability …………………………………………………………………………………………………………………13
7.9 Expiratory impedance ……………………………………………………………………………………………………14
8 Constructional requirements …………………………………………………………………………………………14
8.1 Effects of dropping components of a hand-held spirometer or accessory ………………………14
8.2 Calibration …………………………………………………………………………………………………………………….14
8.3 Dismantling and re-assembly ………………………………………………………………………………………..14
9 Cleaning, sterilization and disinfection ………………………………………………………………………….14
9.1 Re-usable spirometer and parts …………………………………………………………………………………….14
9.2 Spirometer and parts requiring processing before use …………………………………………………..15
9.3 Spirometer and parts delivered sterile ……………………………………………………………………………15
10 Biocompatibility ……………………………………………………………………………………………………………15
Annex A (informative) Rationale ……………………………………………………………………………………………………16
Annex B (normative) Testing accuracy, linearity and impedance of spirometers …………………………… 20
Annex C (normative) Defined test profiles ……………………………………………………………………………………. 24
Annex D (informative) Environmental aspects ……………………………………………………………………………… 27
Annex E (informative) Reference to the essential principals …………………………………………………………. 28
Bibliography ……………………………………………………………………………………………………………………………….. 30
Alphabetized index of defined terms used in this International Standard ……………………………………… 31
Annex ZA (informative) Relationship between this standard and the Essential Requirements of EU
Directive 93/42/EEC ……………………………………………………………………………………………………… 32