The area of application has been expanded to include so-called special TRACHEOTOMY TUBES, as these have numerous requirements in common. A.4 General requirements for TRACHEOTomy tubes and connectors This section has been revised to cover the essential performance and risk management principles associated with respiratory system products and related devices. ISO 18190 describes the need for a risk management file and a recognized process by which the manufacturer of a medical device can identify the hazards associated with the medical device, estimate and assess the risks associated with those hazards, control those risks and monitor the effectiveness of the control . Clinical assessment may also be required to confirm the adequacy of controls (see ISO 18190 for further information). Safety-related examples of the intended use, which may differ from currently accepted medical practice, may include (but are not limited to):
——specific recommendations regarding the patient population for the intended use;
——a requirement that CUFF pressure should be limited;
——a recommendation that the CUFF should not be completely deflated in vivo;
——a recommendation that the TRACHEOTOMY TUBE is not intended for use in a specific patient population, such as premature infants and small-for-age infants and children. A.5 Materials Although the biocompatibility of materials plays a major role in all tracheal tubes and other respiratory products, this feature was considered particularly important for TRACHEOTOMY TUBES, which may remain in situ for several weeks. A.6.2.1 Designated size The designation "diameter" previously used in this International Standard has been changed to size because some TRACHEOTomy tubes are oval. The size listed is the designated size and represents the narrowest measurement across the entire lumen of the tube. This ensures appropriate selection of an INNER TUBE or accessory to fit within the tube. It also identifies the greatest constriction that can cause breathing resistance.
EN ISO 5366:2016 Referenced Document
ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment*， 2024-04-20 Update
ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment*， 2024-04-20 Update
ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use*， 2024-04-20 Update
ISO 18190:2016 Anaesthetic and respiratory equipment - General requirements for airways and related equipment*， 2016-11-01 Update
ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway
EN ISO 5366:2016 history
2016EN ISO 5366:2016 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors