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Standard
ISO 18562-3
Second edition
Biocompatibility evaluation
2024-03
of breathing gas pathways in
healthcare applications —
Part 3:
Tests for emissions of volatile
organic substances
Évaluation de la biocompatibilité des chemins de gaz respiratoire
utilisés dans le domaine de la santé —
Partie 3: Essais concernant les émissions de substances
organiques volatiles
Reference number
ISO 18562-3:2024(en) © ISO 2024
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ISO 18562-3:2024(en)
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Published in Switzerland
© ISO 2024 – All rights reserved
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ISO 18562-3:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General principles . 2
5 Volatile organic substance emissions . . 2
5.1 General .3
5.2 Test method .3
5.3 Assessment of inhalation dose .7
6 Reporting . 8
Annex A (informative) Rationale and guidance . 9
Annex B (informative) Reference to the IMDRF essential principles and labelling guidances .12
Annex C (informative) Reference to the essential principles .13
Annex D (informative) Terminology — Alphabetized index of defined terms. 14
Bibliography .15
© ISO 2024 – All rights reserved
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ISO 18562-3:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normall
...