Name: UNI EN ISO 26782 : 2009
Brand: UNI

ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS

Published date

24-09-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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

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

Committee	CT 44
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current

Standards	Relationship
EN ISO 26782:2009/AC:2009	Identical
ISO 26782:2009	Identical

IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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ISO 14937:2009	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/TR 16142:2006	Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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