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Standards Development
This document specifies the dimensional characteristics of 23 mm tracheostoma connectors It also defines the functional requirements including test methods. This document does neither specify the tracheostomy attachment system nor the tracheostomy accessories except for their connecting interface.
NOTE 1 Requirements on tracheostomy accessories, such as HME filter cassettes, tracheostomy valves, as well as attachment systems such as tracheostoma base plates will be covered by further standards. This document does not cover 15 mm connectors for tracheal or tracheostomy tubes but includes 23 mm connectors for cannulae used for the rehabilitation of patients after laryngectomy.
NOTE 2 For 15 mm connectors for tracheal or tracheostomy tubes, see ISO 5361 and ISO 5366.
The field of application of the connectors specified in this document does not include breathing systems or vaporizers.
Tracheostomy accessories are widely used by patients after tracheostomy or partial or total remove of the larynx to support pulmonary and voice rehabilitation. Tracheostomy accessories are e. g. HME filter cassettes, speaking valves, shower protections, tracheal cannula. To attach these accessories to the patients different tracheostomy attachment systems, such as tracheostoma base plates, are used. Some of them have an integrated connector.
The connection between the tracheostomy accessory and the attachment system must ensure a proper and safe fitting as well as a low leakage. Additionally, it must also ensure that the tracheostomy accessories are easy to connect and to remove. The design of the connection must also prevent that the tracheostomy accessories or their components can be pushed into or fall into the patient’s trachea with the consecutive risk of aspiration and/or suffocation.
In practice, it is necessary to combine tracheostomy accessories and attachment systems of different manufacturers. It is therefore important to standardize the connecting interface of these products.
This document defines the connection between the tracheostomy accessories and the attachment system in order to provide for a reliable and safe system. For this purpose this document specifies the dimensions of the 23 mm tracheostoma connector. It is intended that the following documents on specific tracheostomy accessories use this document as a normative reference for the specification of the connection point of the accessories.
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