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BS EN ISO 16628:2022

$142.49

Anaesthetic and respiratory equipment. Tracheobronchial tubes

Published By Publication Date Number of Pages
BSI 2022 26
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This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required. Tracheal tubes that include bronchus blockers are excluded from the scope of this document

PDF Catalog

PDF Pages PDF Title
2 undefined
5 European foreword
Endorsement notice
9 Foreword
10 Introduction
12 1 Scope
2 Normative references
3 Terms and definitions
13 4 General requirements
4.1 General
4.2 Safety
5 Materials
5.1 General
5.2 Biological safety testing
14 6 Design requirements
6.1 General
6.2 Designated size
6.3 Dimensions
6.4 Connectors
6.5 Cuffs
15 6.6 Cuff inflation system
6.7 Bronchial segment
16 7 Requirements for tracheobronchial tubes supplied sterile
8 Packaging
17 9 Information supplied by the manufacturer
9.1 General
9.2 Marking
9.2.1 Durability and legibility
9.2.2 Marking on the tracheobronchial tube
18 9.3 Colour coding
9.4 Marking on the individual packaging or insert
19 Annex A (informative) Rationale
21 Annex B (normative) Test method to determine the outside diameter of the bronchial segment
22 Annex C (normative) Test method to determine the effective inside diameters
24 Bibliography
BS EN ISO 16628:2022
$142.49