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BS EN ISO 23747:2015 – TC:2020 Edition

$217.84

Tracked Changes. 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 2020 84
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PDF Catalog

PDF Pages PDF Title
46 European foreword
47 Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC
52 Foreword
53 Introduction
55 1 Scope
2 Normative references
3 Terms and definitions
57 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
58 5.2 Marking of the pefm or packaging
5.2.1 Marking of the pefm
5.2.2 Marking of the pefm packaging
59 5.3 Instructions for use
5.4 Technical description
6 ​pefm measurement range
60 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
61 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
62 Annex A (informative) Rationale for tests and examples of test apparatus
65 Annex B (normative) Determination of error, repeatability, and resistance to pefm output
68 Annex C (normative) Determination of frequency response
70 Annex D (normative) Test methods for determination of the effectsof dismantling, ageing and dropping
72 Annex E (informative) Environmental aspects
74 Annex F (informative) Reference to the Essential Principles
78 Annex G (informative) Terminology — Alphabetized index of defined terms
79 Bibliography
BS EN ISO 23747:2015 - TC
$217.84