This standard specifies the requirements for oropharyngeal airways made of plastic and/or rubber materials (including oropharyngeal airways with reinforced inserts made of plastic and/or metal materials). This standard does not apply to metal oropharyngeal airways, nor does it involve flammability requirements for oropharyngeal airways. The flammability of the oropharyngeal airway is a recognized hazard in situations such as the use of flammable anesthetics, electrosurgical equipment, or lasers. This is the domain of clinical management and is outside the scope of this standard. This standard does not apply to upper laryngeal airways without internal, complete sealing devices.
YY/T 0977-2016 Referenced Document
EN 1041 Information supplied by the manufacturer of medical devices
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
GB/T 16273.1 Graphical symbols for use on equipment.Part 1: Common symbols
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 19633.1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems*， 2016-09-01 Update
GB/T 4999-2003 Anaesthetic and respiratory equipment vocabulary
YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
YY/T 0977-2016 history
2023YY/T 0977-2023 Anesthesia and Respiratory Equipment Oropharyngeal Airways
2016YY/T 0977-2016 Anaesthetic and respiratory equipment.Oropharyngeal airways