This standard specifies the basic requirements for upper laryngeal airways and connectors. This device is intended to open and seal the upper larynx to provide an unobstructed passage through the patient's body during spontaneous, assisted, or controlled ventilation. This standard specifies the dimensions, basic characteristics, and specification design methods for available types of upper laryngeal airways. Although most air ducts can be classified according to the specifications and dimensions (or other characteristics) specified in this standard, this standard does not place special requirements on air ducts designed for special purposes.
YY/T 0985-2016 Referenced Document
GB 18278.1 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices*, 2017-01-01 Update
GB 18279.1 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.1 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for 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 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.Part 1:General requirement
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 Anaesthetic and respiratory equipment vocabulary
ISO 11990 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs*, 2018-07-31 Update
ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO/TR 11991 Guidance on airway management during laser surgery of upper airway
YY 0337.1-2002 Tracheal tubes Part 1:----Commonly-used tubes and connectors
YY/T 0486 Requirements for marking and accompanying information on endotracheal tubes for laser surgery*, 2024-02-07 Update
YY/T 1040.1 Anaesthetic and respiratory equipment.Conical connectors.Part 1:Cones and sockets
YY/T 0985-2016 history
2016YY/T 0985-2016 Anaesthetic and respiratory equipment.Supralaryngeal airways and connectors