ASTM F1242-96e1

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: