BS 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

Describes requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans.

This International Standard specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard 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 AnnexE. NOTE Additional aspects of environmental impact are addressed in ISO14971.