Standard Specification for Anesthetic Equipment-Oropharyngeal and Nasopharyngeal Airways (Withdrawn 2009)
This specification covers the minimum performance and safety requirements in terms of size designation, dimensions, and material biocompatibility for oropharyngeal and nasopharyngeal airways that are intended for human use. The airways shall be fabricated from plastics, or elastomeric materials, or from combinations of these materials that shall be nontoxic and compatible with the human tissue with which they are intended to be used. Product marking, labeling, and packaging are also considered.
1.1 This specification covers minimum performance and safety requirements for oropharyngeal and nasopharyngeal airways for human use.
1.2 Size designations, dimensions, and tolerances; material compatibility; product marking and labeling; and packaging are considered.
1.3 Because of the wide variation in size and configuration of the human airway, various conditions of use, user preferences, and cost, this specification cannot cover all types of oropharyngeal and nasopharyngeal airways.
1.4 Standards for the types of airways not specifically addressed by this specification may be developed in the future.
1.5 This specification is not intended to limit the development of the other devices so long as the minimum safety and performance requirements stated herein are met.
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