BS EN ISO 26782:2009 Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans
BS EN ISO 26782 specifies requirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg.
BS EN ISO 26782 applies to a SPIROMETER 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.
Devices intended for continuously monitoring PATIENTS are outside the scope of this International Standard.
Contents of BS EN ISO 26782:
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
Bibliography
Alphabetized index of defined terms used in this International Standard
