UNI EN ISO 26782 : 2009
Current
The latest, up-to-date edition.
ANAESTHETIC AND RESPIRATORY EQUIPMENT - SPIROMETERS INTENDED FOR THE MEASUREMENT OF TIME FORCED EXPIRED VOLUMES IN HUMANS
09-24-2009
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 |
| ISO 26782:2009 | Identical |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 23747:2015 | Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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