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BS EN ISO 23747:2015

BS EN ISO 23747:2015

$167.15

Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

Published By Publication Date Number of Pages
BSI 2015 42
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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 Annex E.

NOTE Additional aspects of environmental impact are addressed in ISO 14971.

PDF Catalog

PDF Pages PDF Title
4 European foreword
5 Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC
10 Foreword
11 Introduction
13 1 Scope
2 Normative references
3 Terms and definitions
15 4 General requirements
4.1 Safety for a pefm that utilizes electricity
4.2 Mechanical basic safety for all pefms
5 Identification, marking and documents
5.1 Marking of the scale or display
16 5.2 Marking of the pefm or packaging
5.2.1 Marking of the pefm
5.2.2 Marking of the pefm packaging
17 5.3 Instructions for use
5.4 Technical description
6 ​pefm measurement range
18 7 Performance requirements
7.1 Error of measurement
7.2 Linearity
7.3 Resistance to flow
7.4 Frequency response
8 Dismantling and reassembly
9 Effects of mechanical ageing
19 10 Effects of dropping a hand-held pefm
11 Cleaning, sterilization, and disinfection
11.1 Reusable pefm and parts
11.2 ​pefm and parts delivered sterile
12 Compatibility with substances
13 Biocompatibility
20 Annex A (informative) Rationale for tests and examples of test apparatus
23 Annex B (normative) Determination of error, repeatability, and resistance to pefm output
26 Annex C (normative) Determination of frequency response
28 Annex D (normative) Test methods for determination of the effectsof dismantling, ageing and dropping
30 Annex E (informative) Environmental aspects
32 Annex F (informative) Reference to the Essential Principles
36 Annex G (informative) Terminology — Alphabetized index of defined terms
37 Bibliography

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BS EN ISO 23747:2015
$167.15