BS EN ISO 26782:2009 - Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans – BSI British Standards

BS EN ISO 26782:2009

Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans

Status : Current   Published : October 2009

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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

 




Standard NumberBS EN ISO 26782:2009
TitleAnaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volumes in humans
StatusCurrent
Publication Date31 October 2009
Normative References(Required to achieve compliance to this standard)ISO 10933-1, ISO 14937, ISO 15223-1:2007, IEC 60601-1:2005
Informative References(Provided for Information)ISO 13485, ISO 14971:2007, ISO/TR 16142, ISO 23747, PD 6461-1, 93/42/EEC
International RelationshipsEN ISO 26782:2009,ISO 26782:2009
Amended ByCorrigendum, April 2010.
Draft Superseded By07/30157348 DC
DescriptorsAnaesthetic equipment, Medical equipment, Medical breathing apparatus, Respiratory system, Lungs, Air, Volume measurement, Clinical investigation instruments, Performance, Marking, Instructions for use
ICS11.040.10
Title in FrenchMatériel d'anesthésie et de réanimation respiratoire. Spiromètres destinés au mesurage des volumes expiratoires forcés chronométrés chez les humains
Title in GermanAnästhesie- und Beatmungsgeräte. Spirometer zur Messung des zeitbezogenen forcierten Exspirationsvolumens beim Menschen
CommitteeCH/121/9
ISBN978 0 580 69712 8
PublisherBSI
FormatA4
DeliveryYes
Pages38
File Size1.23 MB
Price£214.00


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