AAMI ISO 5366-3 pdf free download

AAMI ISO 5366-3 pdf free download.Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy Tubes.
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 1.4.2 Outside diameter 4.2.1 The outside diameter (OD) of sections A and C (see Figure 1 ) of the tube, other than at the cuff if provided, shall be expressed in millimetres to the nearest . NOTE The marked outside diameter relates to that portion of the tube intended to be within the wall and lumen of the trachea. 5 Materials Tracheostomy tubes, including cuffs and tracheostomy tube connectors provided with the tube, in their ready-for-use state after any preparation for use recommended by the manufacturer, shall satisfy appropriate biological safety testing, as indicated in ISO 1 0993-1 . NOTE See annex C for guidance on materials and design. 6 Design and finish 6.1 Machine end The machine end of a paediatric tracheostomy tube shall a) have a permanently attached male conical connector complying with the requirements of ISO 5356-1 , or NOTE In this context, permanently attached means it does not become detached when subject to the forces described in the test method given in annex A. b) accept a paediatric tracheostomy tube connector in accordance with 6.2. 6.2 Paediatric tracheostomy tube connector 6.2.1 The nominal size of a paediatric tracheostomy tube connector shall be designated by its inside diameter in accordance with Table 2. NOTE A connector is intended to fit a tracheostomy tube of the same designated size. 6.2.2 The connector supplied with a tracheostomy tube shall have an inside diameter not less than the inside diameter of that tube as stated by the manufacturer [see 8.1 a)].6.2.3 The machine end shall be a 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 of the patient end of the tracheostomy (outer) tube and not more than 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.AAMI ISO 5366-3 pdf download.