1.1 This specification covers the labeling, marking, warnings, and precautions for cuffed and uncuffed tracheal tubes and related materials intended by the manufacturer for use during laser surgery of the airway.
1.2 Rationale for this specification is to provide a standard format for reporting results obtained from Test Method F1497. Safety and performance tests, with availability of results, are described in this specification to allow a manufacturer the maximum use of technological alternatives in design and materials. This specification addresses the laser resistance of the shaft of the tracheal tubes. Other components of the system, such as the inflation system and cuff, are outside the scope of this specification.
1.3 The values stated in SI units are to be regarded as standard.
Product Details
- Published:
- 01/01/2000
- Number of Pages:
- 3
- File Size:
- 1 file , 31 KB