BS EN ISO 23371:2022

$102.76

Anaesthetic and respiratory equipment. Cuff pressure indication, control and regulation devices

Published By	Publication Date	Number of Pages
BSI	2022	20

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

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This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range. The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.

PDF Catalog

PDF Pages	PDF Title
2	undefined
5	European foreword Endorsement notice
7	Foreword
8	Introduction
9	1 Scope 2 Normative references 3 Terms and definitions
10	4 General requirements 4.1 General 4.2 Alternative test methods
11	5 Materials 6 Design requirements 6.1 General 6.2 Metrological requirements
12	6.3 Connectors 6.4 Integrated cuff pressure indicators
13	6.5 Mechanical strength 7 Requirements for Cuff pressure indication, control and regulation devices supplied sterile
14	8 Packaging 9 Information supplied by the manufacturer 9.1 General 9.2 Marking 9.2.1 General 9.2.2 Markings 9.3 Instructions for use
16	Annex A (Informative) Rationale
17	Bibliography