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BS EN ISO 5362:2024

$109.61

Anaesthetic and respiratory equipment. Anaesthetic reservoir bags

Published By Publication Date Number of Pages
BSI 2024 24
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This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity. This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems. The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 General requirements
5 Materials
5.1 General
5.2 Biocompatibility evaluation of the breathing gas pathways
5.3 Material recommendations
6 Design requirements
6.1 General
6.2 Designated size
6.3 Leakage
11 6.4 Necks
12 6.5 Tails
13 6.6 Elastic resistance
6.7 Elastic recovery
7 Requirements for anaesthetic reservoir bags supplied sterile
8 Packaging
14 9 Information supplied by the manufacturer
9.1 General
9.2 Marking
15 Annex A (informative) Rationale
16 Annex B (normative) Leakage test
17 Annex C (normative) Determination of designated size
18 Annex D (normative) Test for security of attachment of plain neck to a 22 mm cone conical connector
19 Annex E (normative) Test for security of attachment of adaptor of assembled neck
20 Annex F (normative) Test for elastic resistance and elastic recovery
21 Annex G (informative) Recommendations for materials
22 Annex H (informative) Hazard identification for risk assessment
23 Bibliography
BS EN ISO 5362:2024
$109.61