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BS EN ISO 5367:2023 – TC

BS EN ISO 5367:2023 – TC

$217.84

Tracked Changes. Anaesthetic and respiratory equipment. Breathing sets and connectors

Published By Publication Date Number of Pages
BSI 2023 100
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This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions. This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end. Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.

PDF Catalog

PDF Pages PDF Title
66 undefined
68 European foreword
Endorsement notice
70 Foreword
71 Introduction
73 1 Scope
2 Normative references
3 Terms and definitions
74 4 General requirements
4.1 General
4.2 Recommended service life
5 Materials
5.1 General
5.2 Biological safety testing
6 Design requirements
6.1 General
6.2 Designated length
75 6.3 Breathing tube ends
76 6.4 Leakage
6.5 Resistance to flow
77 6.6 Compliance
78 6.7 Axial strength of breathing tubes
7 Requirements for breathing sets and breathing tubes supplied sterile
8 Packaging
9 Information supplied by the manufacturer
9.1 General
79 9.2 Marking on the packaging
9.3 Instructions for use
81 Annex A (informative) Rationale
86 Annex B (informative) Hazard identification for risk management
87 Annex C (normative) Test for security of attachment of plain end to conical connector
88 Annex D (normative) Test for security of attachment of assembled ends and axial strength of breathing tubes
90 Annex E (normative) Test for leakage
92 Annex F (normative) Measurement of resistance to flow
95 Annex G (normative) Test for increase in flow resistance with bending
97 Annex H (normative) Test for compliance
99 Bibliography

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BS EN ISO 5367:2023 - TC
$217.84