Scope
1.1 This specification covers the dimensions, rationale, labeling specifications, selected performance requirements, and test methods of cuffed and uncuffed Magill and Murphy-type tracheal tubes. These tubes are commonly used as airway catheters in human patients in the practice of anesthesiology and in respiratory care. This specification represents the state of the art at the time of publication and will be subject to periodic review.
1.2 This specification also provides test protocols to assess the performance and safety of cuffed oral and nasal tracheal tubes for prolonged use. Supporting rationale for the requirements is provided in Appendix X1, and references are included. Required safety and performance tests, together with availability of results, are relied upon in this specification, whenever possible, to allow a manufacturer the maximum use of technological alternatives in design and materials.
1.3 The values stated in SI units are to be regarded as standard.
1.4 The following precautionary caveat pertains to the test method portions, Annex A1 and Appendix X2, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
1.5 The following is a list of subject headings and subheadings included in this specification and the sections in which they appear:
Sections Scope 1 Referenced Documents 2 Terminology 3 Materials 4 Inertness 4.1 Surface Characteristics 4.2 Rigidity 4.3 Integrity of Lumen 4.4 Requirements for Tubes With Cuffs 5 Cuffs 5.1 Cuff Pressure, Volume, and Diameter Characteristics 5.2 Inflation System 5.3 Dimensions, and Permissible Variations of Tracheal Tubes 6 Measurement System 6.1 Size and Dimensions 6.2 Radius of Curvature 6.3 Bevel 6.4 Murphy Eye 6.5 Product Marking 7 Marking Materials 7.1 Tracheal Tube Markings 7.2 Required Markings 7.3 Packaging and Labeling 8 Gas Effects 8.1 Sterile Tubes 8.2 Nonsterile Tubes 8.3 Disposable Tubes 8.4 Reusable Tracheal Tubes 8.5 Storage Conditions 8.6 Tables Tracheal Tube Dimensions 1 Dimensions of Cuffed Tracheal Tubes 2 Figures Tracheal Tube 1 Cuffed Tracheal Tube 2 Typical Murphy Tips 3 Rationale for Requirements X1 Test Methods A1 Implantation Test A1.1 Tube Collapse A1.2 Cuff Symmetry A1.3 Cuff Herniation A1.4 Cuff Pressure, Volume, and Diameter Assessment; and Tube Lumen Closure A1.5 Radiopaque Markers A1.6 Leak Test A1.7 Determination of Test Inflation Pressure Table A1.1 Test for Tube Collapse Fig. A1.1 Test Rig Fig. A1.2 Visual Inspection of Tube Cuff Fig. A1.3 Cuff Herniation Test Fig. A1.4 Clear Polyvinyl Chloride Adult Model Trachea Fig. X2.1 Schematic of Cuffed Tracheal Tube in Model Trachea Mounted Vertically in Test Apparatus Fig. X2.2 Discontinued Test Protocols X2 Test Protocols X2.1 Test Protocol One-Tracheal Seal, Slope Pressure, and Lumen Closure Conditions X2.2 Test Protocol Two-Ability to Conform to Human Anatomy and Resistance to Kinking X2.3 Coordinates for Positioning Pegs on Test Board Table X2.1 Test Board Fig. X2.3
