BS EN ISO 16628:2022 – TC

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Tracked Changes. Anaesthetic and respiratory equipment. Tracheobronchial tubes

Published By	Publication Date	Number of Pages
BSI	2022	52

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Categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment, BSI

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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
1	30459884
27	A-30406875
28	undefined
31	European foreword Endorsement notice
35	Foreword
36	Introduction
38	1 Scope 2 Normative references 3 Terms and definitions
39	4 General requirements 4.1 General 4.2 Safety 5 Materials 5.1 General 5.2 Biological safety testing
40	6 Design requirements 6.1 General 6.2 Designated size 6.3 Dimensions 6.4 Connectors 6.5 Cuffs
41	6.6 Cuff inflation system 6.7 Bronchial segment
42	7 Requirements for tracheobronchial tubes supplied sterile 8 Packaging
43	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
44	9.3 Colour coding 9.4 Marking on the individual packaging or insert
45	Annex A (informative) Rationale
47	Annex B (normative) Test method to determine the outside diameter of the bronchial segment
48	Annex C (normative) Test method to determine the effective inside diameters
50	Bibliography