Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Electrical safety
4.2 Mechanical safety
5 Identification, marking and documents
5.1 Marking of the scale or display
5.2 Legibility of markings
5.3 Durability of markings
5.4 Marking of the spirometer or its packaging
5.5 Instructions for use
5.6 Technical description
6 Measurement range
7 Performance requirements
7.1 Accuracy
7.2 Recording time
7.3 Graphical display aspect ratios
7.4 Volume recording
7.5 Start of forced exhalation
7.6 End of forced exhalation
7.7 Linearity
7.8 Repeatability
7.9 Expiratory impedance
8 Constructional requirements
8.1 Effects of dropping components of a hand-held spirometer
or accessory
8.2 Calibration
8.3 Dismantling and re-assembly
9 Cleaning, sterilization and disinfection
9.1 Re-usable spirometer and parts
9.2 Spirometer and parts requiring processing before use
9.3 Spirometer and parts delivered sterile
10 Biocompatibility
Annex A (informative) Rationale
Annex B (normative) Testing accuracy, linearity and impedance
of spirometers
Annex C (normative) * Defined test profiles
Annex D (informative) Environmental aspects
Annex E (informative) Reference to the essential principals
Alphabetized index of defined terms used in this
International Standard
Annex ZA (informative) Relationship between this standard
and the Essential Requirements of EU Directive
93/42/EEC
Bibliography