ISO 5366-3:2001 pdf download

ISO 5366-3:2001 pdf download.Anaesthetic and respiratory equipment- Tracheostomytubes – Part 3:aediatric tracheostomy tubes.
6.2.3 The machine end shall be a 15 mm male conical connector complying with ISO 5356-1. The inside diameter of the conical connector at the machine end shall be not less than that allowed by Table 2 for the patient end.
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, if provided with the outer tube, shall extend to within 1,0 mm of the patient end of the tracheostomy (outer) tube and not more than 1,0 mm beyond the patient end.
6.3.2 The machine end of the inner tube shall either comply with 6.1 or shall not 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 If a tracheostomy tube has an adjustable neck-plate, it shall 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
6.5.1 A cuff, if provided, shall be permanently attached to the tube.
6.5.2 Cuffs of tracheostomy tubes shall satisfy the requirements of ISO 5361.
6.5.3 The cuff resting diameter shall be within + 15 % of the marked value [see 8.3.2 m)J 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 tracheostomy 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 shall have a pilot balloon and/or other device to indicate inflation/deflation of the cuff.
NOTE This (these) device(s) can also serve as a pressure-indicating or -limiting device.
6.6.3 Free end of Inflating tubes for cuffs
The end of the inflating tube shall 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 free end of the inflating tube shall be not less than 40 mm unless an inflation valve or closure device is provided.
If an inflation valve or closure device is provided, the length [see Figure 1 b), dimension 12 of ISO 5366-1:2000] between the pilot balloon (or other device) and the female fitting which accepts a male Luer conical fitting shall be not less than 10mm unless the pilot balloon and valve or closure device are integral.
NOTE This is to facilitate clamping of the inflating tube.
6.7 Patient end
If a bevel is present, the angle of the bevel 3 shall be not less than 500 [see Figure 1 b)].
6.8 Introducer
If provided, the introducer, when correctly seated, shall not fall 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 marked “STERILE” shall satisfy 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 examination of the intact unit container:
a) the size and pre-formed shape of the tube;
b) whether a cuff is provided;
c) whether a connector is provided.
NOTE For example, the unit container can be transparent and the tube visible, or a drawing to scale (preferably full-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 effective barrier to the penetration of microorganisms and particulate material, in accordance with ISO 11607. The pack shall permit the aseptic extraction of the contents and shall 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 from the machine end of the tube:
a) the designated size (nominal inside diameter) expressed in millimetres in accordance with 4.1;
b) the nominal outside diameter expressed in millimetres in accordance with 4.2;
c) the name and/or trade mark of the manufacturer.