ISO 5366-3 pdf download – Anaesthetic and respiratory equipment-Tracheostomytubes 一 Part 3: Paediatric tracheostomy tubes.
6.2.4 Any transition from One inside diameter to another shall be tapered to give an adequate lead-in for passage of a suction catheter.
6.3 Inner tube
6.3.1 the inner tube, Pt provided with the outer tube, shall extend to within 1.0mm of the patient end of the tracheostomy (outer) tube and not more than 1,0mm beyond the patient end,
6.3.2 The machine end of the inner tube shall eith comply with 6.1 or shall riot prevent the tracheostomy (outer) tube connector, if provided, mating with the breathing system of an anaesthetic machine or lung ventilator,
6.4 Neck-plate
6.4.1 Tracheostomy tubes shall have a neck-plate that shall be either adjustable or permanently attached to the tube.
6.4.2 The neck-plate shall be provided with holes or other means to permit attachment to the patient.
6.4.3 It a tracheostomy tube has an adjustable neck-plate, it 5hall be securable to the tube (but see C.2.4).
6.4.4 When tested in accordance with annex A, the neck-plate shall not move longitudinally relative to the tube.
6.5 Cuff
6.51 A cuff, if provided, shall be permanently attached to the tub.
6.5.2 Cuffs of tracheostormy tubes shall satisfy the requirements of ISO 5361.
6.5.3 The cuff resting diameter shall be within ± 15% of the marked value Ieee 8.3.2 m)I when determined in
accordance with annex B.
6.6 InflatIng tubes for cuffs
6.6.1 Inflating tubes
The inflating tube, if fitted, shall have an outside diameter of not more than 2.5 mm. The wall around the inflation lumen shall not encroach on the lumen of the tracheostomy tube by more than 10% of the inside diameter of the tracheoslomy tube.
The intentional deflation of the cuff shall not be prevented by the inflating tube, inflating valve or any closure device.
6.6.2 PIlot balloon
The inflating tube chaP have a pilot balloon and!or other device to indicate inflahon/deflation of the cuff.
NOTE This (these) device(s) can ako serve as a pressur.-indicatrng o 4lmiting device
6.6.3 Free end of inflatIng tubes for cuffs
The end of the inflating tube shalt be either open or sealed with a closure device or inflation valve, but in all instances it shall be capable of accepting a male conical fitting with a 6% taper (Luer). complying with the requirements specified in ISO 594-1. The length (see Figure 1 a), dimension 1, of ISO 5366-1:2000] of the tree end of the inflating tube shal be not less than 40mm unless an inflation valve or closure device is provided.
If an inflation valve o closure device is provided, the length (see Figure 1 b), dwnension ‘2 of ISO 5366-1:20001 between the pilot balloon (or other device) and the female fining which accepts a male Luer conical fitting shall be not less than 10mm unless the pdol balloon and valve or closure device are integral.
NOTE This is to facitale clamping of the inf%atmg tube
6.7 Patlent end
If a bevel is present, the angle of the bevel 3 shall be not less than 500 (see Figure 1 bfl.
6.8 Introducer
If provided, the introducer, when correctly seated, shall not tall out of the paediatric tracheostomy tube under its own weight when the tube is held by the neck-plate with the patient end uppermost
The introducer should be freely removable in use.
7 Requirements for tracheostomy tubes supplied sterile
7.1 SterilIty assurance
Tracheostomy tubes supplied and rmarxeO STERILE shall satiety the requirements of 4.1 of EN 556:1994
7.2 Packaging for tracheostomy tubes supplied sterile
7,2.1 The following information shall be apparent on visual examwation of the intact unit container:
a) the size and pie-formed shape of the tube:
b) whether a cuff is provided;
C) whether a connector is provided.
NOTE For examp. the un coiainer can be transparent and the tube visibli, or a drawing to scale (prebrabty I uI-scale can be used
7.2.2 Each tracheostomy tube supplied and marked STERILE shall be contained in a unit container. The container shall serve as an effectrve barrier to the penetration of microorganisms and particulate material, en accordance with ISO 11607. The pack shall permit the aseptic extraction of the contents and shell not be capable of re-closure without clearly revealing that it has been opened.
8 Marking
8.1 MarkIng of tracheostomy tube
The following information shall be marked on the neck-plate and/or tube and shall be visible Irom the machine end of the tube:
a) the designated size (nominal inside diameter) expressed in millimetres in accordance with 4,1.
ISO 5366-3 pdf download – Anaesthetic and respiratory equipment-Tracheostomytubes 一 Part 3: Paediatric tracheostomy tubes
