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.
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Sisällysluettelo
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
Alphabetized index of defined terms used in this International Standard
Annex A Rationale (informative)
Annex B Testing accuracy, linearity and impedance of spirometers (normative)
Annex C * Defined test profiles (normative)
Annex D Environmental aspects (informative)
Annex E Reference to the essential principals (informative)
IEC 60601-1:2005
ISO 10993-1:2003 Biological evaluation of medical devices -- Part 1: Evaluation and testing
ISO 14937:2000 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
IEC 60601-1:2005
ISO 10993-1:2003 Biological evaluation of medical devices -- Part 1: Evaluation and testing
ISO 14937:2000 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 15223-1:2007 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements