AAMI ISO 5366-3:2001 pdf download – Anaesthetic and respiratory equipment – Tracheostomy tubes
1 Scope
This part of ISO 5366 gives requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from to . Requirements for paediatric tracheostomy tube connectors and adaptors are also given.
This part of ISO 5366 is not applicable to specialized tracheostomy tubes.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 5366. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 5366 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references,
the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
ISO 594-1 , Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment —Part 1 : General requirements .
ISO 5356-1 , Anaesthetic and respiratory equipment — Conical connectors — Part 1 : Cones and sockets
ISO 5361 , Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 5366-1 :2000, Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1 : Tubes and connectors for use in adults .
ISO 1 0993-1 , Biological evaluation of medical devices — Part 1 : Evaluation and testing .
ISO 1 1 607, Packaging for terminally sterilized medical devices .
EN 556:1 994, Sterilization of medical devices — Requirements for medical devices to be labelled “STERILE” .
3 Terms and definitions
For the purposes of this part of ISO 5366, the terms and definitions given in ISO 5366-1 and the following apply.
3.1 paediatric tracheostomy tube
tube designed for insertion into the trachea of an infant or child through a tracheostomy
3.2 paediatric tracheostomy tube connector
tubular component which fits directly into the paediatric tracheostomy tube
3.3 machine end
paediatric tracheostomy tube connector end of the component nearest the machine which is intended to mate with the breathing system of an anaesthetic machine or lung ventilator
3.4 patient end
paediatric tracheostomy tube connector end of the component nearest the patient which is inserted into the paediatric tracheostomy tube
4 Size designation and dimensions
4.1 Designation of size of tube
4.1.1 The size of a tracheostomy tube (outer tube) shall be designated by the nominal inside diameter (ID) of the tube expressed in millimetres, as measured at the minimum diameter, in accordance with Table 1 , excluding any encroachment allowed by 6.6.1 .
4.1.2 For tracheostomy tubes provided with an inner tube to which is attached a male conical connector complying with the requirements of ISO 5356-1 [see 6.1 a)], the size shall be designated by the nominal inside diameter (ID) of the inner tube expressed in millimetres in accordance with Table 1.