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BS EN ISO 5361:2023

BS EN ISO 5361:2023

$198.66

Anaesthetic and respiratory equipment. Tracheal tubes and connectors

Published By Publication Date Number of Pages
BSI 2023 56
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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
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 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
12 6 Design requirements
6.1 General
6.2 Size designation
6.3 Dimensions
6.3.1 Tracheal tubes
16 6.3.2 Tracheal tube connectors
18 6.4 Tracheal tube bevel
6.5 Tracheal tube cuffs
19 6.6 Cuff inflating system
20 6.7 Tracheal tube curvature
6.8 Surface finish
22 6.9 Radiopaque marker
6.10 Kink resistance
6.11 Additional requirements for tracheal tubes with a Murphy eye
23 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
24 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
25 9.5 Instructions for use
27 Annex A (informative) Rationale
33 Annex B (informative) Guidance on the design of tracheal tubes and tracheal tube connectors
38 Annex C (normative) Determination of cuff diameter
39 Annex D (normative) Test method for cuffed tube collapse
42 Annex E (normative) Test method for cuff herniation
44 Annex F (normative) Test method for tracheal seal
47 Annex G (informative) Hazard identification for risk assessment
50 Annex H (normative) Test method to determine kink resistance
52 Bibliography

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BS EN ISO 5361:2023
$198.66