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BS EN ISO 5361:2023 – TC

BS EN ISO 5361:2023 – TC

$258.95

Tracked Changes. Anaesthetic and respiratory equipment. Tracheal tubes and connectors

Published By Publication Date Number of Pages
BSI 2023 112
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This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications. Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document. Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document. NOTE 1      There is guidance or rationale for this clause contained in Annex A.2. NOTE 2      ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.

PDF Catalog

PDF Pages PDF Title
60 undefined
62 European foreword
Endorsement notice
65 Foreword
66 Introduction
67 1 Scope
2 Normative references
3 Terms and definitions
69 4 General requirements
4.1 General
4.2 Safety
5 Materials
5.1 General
5.2 Biological safety testing
5.3 Reuse requirements
5.4 Flexibility
70 6 Design requirements
6.1 General
6.2 Size designation
6.3 Dimensions
6.3.1 Tracheal tubes
74 6.3.2 Tracheal tube connectors
76 6.4 Tracheal tube bevel
6.5 Tracheal tube cuffs
77 6.6 Cuff inflating system
78 6.7 Tracheal tube curvature
6.8 Surface finish
80 6.9 Radiopaque marker
6.10 Kink resistance
6.11 Additional requirements for tracheal tubes with a Murphy eye
81 7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile
8 Packaging for tracheal tubes and tracheal tube connectors supplied sterile
9 Information supplied by the manufacturer on the tracheal tube, individual pack or the instructions for use
9.1 General
9.2 Durability of tracheal tube markings
82 9.3 Marking
9.3.1 Tracheal tubes shall be clearly and legibly marked with:
9.3.2 Marking on tracheal tube connectors
9.4 Placement of marking
83 9.5 Instructions for use
85 Annex A (informative) Rationale
91 Annex B (informative) Guidance on the design of tracheal tubes and tracheal tube connectors
96 Annex C (normative) Determination of cuff diameter
97 Annex D (normative) Test method for cuffed tube collapse
100 Annex E (normative) Test method for cuff herniation
102 Annex F (normative) Test method for tracheal seal
105 Annex G (informative) Hazard identification for risk assessment
108 Annex H (normative) Test method to determine kink resistance
110 Bibliography

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BS EN ISO 5361:2023 - TC
$258.95