4.1 This specification applies to rigid bronchoscopes, those endoscopic accessories through which rigid bronchoscopes are used, those accessories which are passed through rigid bronchoscopes in use, and those associated accessories which are inserted into the body.

This specification covers the definitions, and critical dimensional and design requirements for rigid bronchoscopes and certain bronchoscopic accessories, such as those endoscopic accessories through which rigid bronchoscopes are used, those accessories which are passed through rigid bronchoscopes in use, and those associated accessories which are inserted into the body in the practice of medicine. Product marking, labeling, and packaging are also discussed.