BS EN ISO 8836:2014 pdf – Suction catheters for use in the respiratory tract (ISO 8836:2014)

BS EN ISO 8836:2014 pdf – Suction catheters for use in the respiratory tract (ISO 8836:2014).
4.2 Safety The manufacturer may use type tests different from those detailed within this International Standard, if an equivalent degree of safety is obtained. Alternative test methods shall be validated against the test methods specified in this International Standard. 5? Specific? requirements? for? open? and? closed? suction? catheters 5.1 Size and length designations 5.1.1 The size of suction catheters shall be designated by the nominal outside diameter of the shaft, expressed in millimetres; it may additionally be expressed in French (Charriere) gauge size (see Table 1). NOTE 1 For the purposes of this International Standard, the French gauge system of size (F) is based on the outside diameter of the shaft gauged in steps of thirds of a millimetre (1 mm corresponds to 3F). NOTE 2 The French gauge size is not an SI unit. Size designation in millimetres facilitates matching the suction catheter outside diameter to the inside diameter of the tracheal or tracheostomy tube. 5.1.2 The size of the suction catheter shall also be designated by use of colour identification at the machine end in accordance with Table 1, for the designated sizes listed. 5.1.3 The use and choice of colour identification for designated sizes not listed in Table 1 are at the manufacturer’s discretion. 5.1.4 The length of the suction catheter shall be designated by the nominal shaft length, expressed in millimetres. 5.2 *Dimensions 5.2.1 The outside diameter of the shaft shall be the designated nominal outside diameter, subject to a tolerance in accordance with Table 1. 5.2.2 The minimum inside diameter of the shaft, excluding the tip, shall be in accordance with Table 1. 5.2.3 The minimum inside diameter of the terminal? orifice at the tip shall be not less than 90 % of the minimum inside diameter in accordance with Table 1. 5.2.4 The shaft length shall be the designated nominal shaft length subject to a tolerance of ±5 %.
6 Materials 6.1 Open and closed suction catheters for use in the respiratory tract, in their ready-to-use state after any preparation for use recommended by the manufacturer, shall satisfy appropriate biological safety testing, as indicated in ISO 10993-1. 6.2 Open and closed suction catheters for use in the respiratory tract, in their ready-to-use state after any preparation for use recommended by the manufacturer shall not contain natural rubber latex. Check compliance by inspection of the technical documentation. 6.3 The outside surface of the shaft of the suction catheter shall be free from characteristics which would hinder easy insertion through all types of plastic, rubber and metal oro- and naso-tracheal tubes, tracheostomy tubes and appropriate connectors. Check compliance by visual inspection. 6.4 Suction catheters and their markings should be resistant to deterioration by anaesthetic vapours and gases. 6.5 The marking of suction catheters shall be durable and legible Check compliance by inspection, as indicated in 6.4.1 of ASTM D3002:2007 or in simulated use.
7 *Design 7.1 Lumen of the suction catheter The inside diameter of the shaft at any point between the suction catheter connector machine end and the eye nearest to the machine end shall be not less than the inside diameter of the shaft at that eye. 7.2 Suction catheter tip 7.2.1 Suction catheters on which the patient end cannot be observed during use or which are for use with suction systems operating at a vacuum pressure > 3,92 kPa, (40 cmH 2 O), shall have a terminal orifice and at least one eye within 2 cm of the terminal? orifice. NOTE The availability of one or more eyes reduces the risk and likelihood of injury. 7.2.2 Suction catheters that can be observed during use, or are for use with suction systems operated at vacuum from 0 cm H 2 O to 40 cmH 2 O (3,92 kPa), need not have an eye. 7.2.3 The edges of the tip, terminal? orifice and eye(s) shall be smooth. NOTE This is to minimize injuries of the tracheal epithelium. Check compliance by visual inspection. 7.2.4 The eye(s) should not cause the suction catheter to kink or collapse during use. 7.2.5 The axis of the patient end may be at an angle to the long axis of the shaft (see Coudé catheter tip in Figure 1). NOTE This is to facilitate the introduction of the suction catheter into the left or main bronchus. 7.3 *Suction catheter connector 7.3.1 A suction catheter shall be provided with a male suction catheter connector intended for connection to the end-piece of suction tubing attached to a collection container that complies with ISO 10079-1, ISO 10079-2, and ISO 10079-3. A male suction catheter connector is required in order to comply with the ISO 10079-1, ISO 10079-2, and ISO 10079-3 requirement that connections for the suction tubing be so designed as to minimize the risk of wrong assembly when all parts are mated.