EN ISO 23747:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Identification, marking and documents
6 PEFM measurement range
7 Performance requirements
8 Dismantling and reassembly
9 Effects of mechanical ageing
10 Effects of dropping a hand-held PEFM
11 Cleaning, sterilization, and disinfection
12 Compatibility with substances
13 Biocompatibility
Annex A (informative) - Rationale for tests and examples
        of test apparatus
Annex B (normative) - Determination of error, repeatability,
        and resistance to PEFM output
Annex C (normative) - Determination of frequency response
Annex D (normative) - Test methods for determination of the
        effectsof dismantling, ageing and dropping
Annex E (informative) - Environmental aspects
Annex F (informative) - Reference to the Essential
        Principles
Annex G (informative) - Terminology - Alphabetized index of
        defined terms
Bibliography
Annex ZA (informative) - Relationship between this
         Document and the Essential Requirements of
         EU Directive 93/42/EEC

ISO 23747:2015 specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans.ISO 23747:2015 covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device.Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E.NOTE Additional aspects of environmental impact are addressed in ISO 14971.