BS EN ISO 5366-1:2004
$142.49
Anaesthetic and respiratory equipment. Tracheostomy tubes – Tubes and connectors for use in adults
| Published By | Publication Date | Number of Pages |
| BSI | 2004 | 28 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | Anaesthetic and respiratory equipment�— Tracheostomy tubes�— |
| 7 | Contents Page |
| 8 | Foreword |
| 9 | Introduction |
| 11 | Anaesthetic and respiratory equipment�— Tracheostomy tubes�— 1��� Scope 2��� Normative references 3��� Terms and definitions |
| 14 | 4��� Size designation and dimensions 4.1��� Inside diameter 4.1.1��� The size of the tracheostomy tube (outer tube) shall be designated by the nominal inside… |
| 15 | 4.1.2��� For tracheostomy tubes with the conical connector permanently attached to the inner tube… 4.2��� Outside diameter 4.2.1��� The outside diameter (OD) of sections 4.2.2��� The actual outside diameter of section 4.2.3��� The actual outside diameter of section 4.3��� Length 4.3.1��� The nominal length (dimensions 4.3.2��� The actual nominal length (dimensions 4.3.3��� For tubes with an adjustable neck-plate, the range of measurements for nominal length (s… 4.3.4��� Dimensions 4.4��� Angle |
| 16 | 5��� Materials 6��� Design and finish 6.1��� Machine end 6.1.1��� Tracheostomy tubes or their inner cannulae shall have at the machine end a permanently a… 6.1.2��� The inside diameter of the conical connector at the machine end shall be not less than t… 6.1.3��� Any transition in inside diameter shall be tapered to give an adequate lead-in for passa… 6.1.4��� When tested in accordance with annex� 6.2��� Neck-plate 6.2.1��� Tracheostomy tubes shall have a neck-plate which shall be adjustable or permanently atta… 6.2.2��� The neck-plate shall be provided with holes or other means to permit attachment to the p… 6.2.3��� If a tracheostomy tube has an adjustable neck-plate, it shall be securable to the tube. … 6.2.4��� When tested in accordance with annex� 6.3��� Inner tube 6.3.1��� The inner tube, if provided with the outer tube, shall extend to within 6.3.2��� The machine end of the inner tube shall either comply with 6.4��� Cuff 6.4.1��� A cuff, if provided, shall be permanently attached to the tube. 6.4.2��� Cuffs of tracheostomy tubes shall satisfy the requirements of 6.4.3��� The cuff resting diameter shall be within |
| 17 | 6.5��� Inflating tubes for cuffs 6.5.1��� Inflating tube 6.5.2��� Pilot balloon 6.5.2.1��� The inflating tube shall have a pilot balloon and/or other means to indicate inflation… 6.5.2.2��� The intentional evacuation of the cuff shall not be prevented by the inflating tube, i… 6.5.3��� Free end of inflating tubes for cuffs 6.6��� Patient end 6.7��� Introducer 7��� Requirements for tracheostomy tubes supplied sterile 7.1��� Sterility assurance |
| 18 | 7.2��� Packaging for tracheostomy tubes supplied sterile 7.2.1��� The following information shall be apparent on visual examination of the intact unit con… 7.2.2��� Each tracheostomy tube supplied and marked as “STERILE” shall be contained in an individ… 8��� Marking and labelling 8.1��� General 8.2��� Marking of the neck-plate 8.2.1��� The following information shall be marked on the neck-plate and shall be visible from th… 8.2.2��� Cuffed tubes intended for reuse shall be marked with the resting diameter of the cuff de… 8.3��� Labelling of unit packs 8.3.1��� Use of symbols 8.3.2��� Labelling of tracheostomy tube unit packs |
| 19 | 8.3.3��� Labelling of inner tube unit packs |
| 20 | Test method for the security of attachment of connector and neck-plate to tracheostomy tube A.1��� Principle A.2��� Apparatus A.2.1��� Means of conditioning A.2.2��� Means of securing A.2.3��� Means of securing A.3��� Procedure A.3.1��� Condition the tracheostomy tube at A.3.2��� Remove the tracheostomy tube from the conditioning chamber and secure the connector and … A.3.3��� Within A.3.4��� Having already removed the tracheostomy tube from the conditioning chamber, secure the n… A.3.5��� Within A.4��� Expression of results |
| 21 | Test method for determining the resting diameter of the cuff B.1��� Principle B.2��� Apparatus B.3��� Procedure B.3.1��� Inflate the cuff with sufficient air to create an internal overpressure of B.3.2��� Locate the plane of maximum cuff diameters perpendicular to the axis of the tube. Measur… B.4��� Expression of results |
| 22 | Guidance on materials and design C.1��� Materials C.1.1��� The materials used for the manufacture of the tubes should have sufficient rigidity to a… C.1.2��� Unless intended and marked for single use, tracheostomy tubes should be reasonably resis… C.1.3��� Tracheostomy tubes under normal conditions of use should be reasonably resistant to dete… C.1.4��� Tracheostomy tubes should be readily detectable by X-ray either by the nature of the mat… C.1.5��� When not in use the tracheostomy tube should maintain its intended shape when stored in … C.2��� Design C.2.1��� Tracheostomy tubes, including the neck-plate, should have smooth external and internal s… C.2.2��� The patient end of the tracheostomy tube should be free from sharp edges. C.2.3��� The neck-plate should be rounded at the edges, and its shape should adapt to the contour… C.2.4��� For tracheostomy tubes with an adjustable neck-plate, use of the mechanism for securing … C.2.5��� A retaining or latching device may be incorporated in the design to provide added securi… |
| 23 | Bibliography |
