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 |
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 |