ASTM F1242 PDF

Standard Specification for Cuffed and Uncuffed Tracheal Tubes (Withdrawn 2002)

ASTM F1242 – Standard Specification for Cuffed and Uncuffed Tracheal Tubes (Withdrawn 2002)

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:

SectionsScope 1 Referenced Documents2 Terminology 3 Materials 4Inertness4.1Surface Characteristics4.2Rigidity 4.3Integrity of Lumen 4.4 Requirements for Tubes With Cuffs 5Cuffs5.1Cuff Pressure, Volume, and Diameter Characteristics5.2Inflation System 5.3 Dimensions, and Permissible Variations of TrachealTubes6Measurement System 6.1Size and Dimensions6.2Radius of Curvature6.3Bevel6.4Murphy Eye 6.5 Product Marking 7Marking Materials7.1Tracheal Tube Markings 7.2Required Markings7.3 Packaging and Labeling8Gas Effects8.1Sterile Tubes8.2Nonsterile Tubes 8.3Disposable Tubes 8.4Reusable Tracheal Tubes8.5Storage Conditions 8.6Tables Tracheal Tube Dimensions 1 Dimensions of Cuffed Tracheal Tubes2 Figures Tracheal Tube1 Cuffed Tracheal Tube 2 Typical Murphy Tips3 Rationale for RequirementsX1 Test MethodsA1Implantation TestA1.1Tube CollapseA1.2Cuff SymmetryA1.3Cuff HerniationA1.4Cuff Pressure, Volume, and DiameterAssessment; and Tube Lumen Closure A1.5Radiopaque Markers A1.6Leak TestA1.7 Determination of Test Inflation Pressure Table A1.1 Test for Tube CollapseFig. A1.1 Test RigFig. A1.2 Visual Inspection of Tube CuffFig. A1.3 Cuff Herniation TestFig. A1.4 Clear Polyvinyl Chloride Adult Model TracheaFig. X2.1 Schematic of Cuffed Tracheal Tube in Model TracheaMounted Vertically in Test Apparatus Fig. X2.2 Discontinued Test Protocols X2 Test ProtocolsX2.1 Test Protocol One-Tracheal Seal, Slope Pressure,and Lumen Closure Conditions X2.2 Test Protocol Two-Ability to Conform to HumanAnatomy and Resistance to KinkingX2.3 Coordinates for Positioning Pegs on Test Board Table X2.1 Test BoardFig. X2.3