BS EN ISO 26782:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Identification, marking and documents
6 Measurement range
7 Performance requirements
8 Constructional requirements
9 Cleaning, sterilization and disinfection
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
Annex ZA (informative) - Relationship between this standard
                         and the Essential Requirements of
                         EU Directive 93/42/EEC

Defines requirements for SPIROMETERS intended for the assessment of pulmonary function in humans weighing more than 10 kg.

This International Standard specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10kg. This International Standard 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.