EN ISO 5361:2016
Anaesthetic and respiratory equipment - Tracheal tubes and connectors

Standard No.
EN ISO 5361:2016
Release Date
2016
Published By
European Committee for Standardization (CEN)
Status
 2023-05
Replace By
EN ISO 5361:2023
Latest
EN ISO 5361:2023
Replace
FprEN ISO 5361:2016
Scope
This International Standard contains the essential performance and safety requirements for orotracheal and nasotracheal tubes and tracheal tube connectors. Tracheal tubes with metal or nylon reinforced walls, tracheal tubes with shoulders, conical tracheal tubes, tracheal tubes with suction, monitoring or drug or other gas delivery capabilities, and the many other types of specialty tracheal tubes are included in this International Standard because numerous Special tracheal tubes are commonly used today and all have similar basic requirements in accordance with this International Standard. Endobronchial tubes (including tracheobronchial tubes), tracheostomy tubes and supralaryngeal airway devices are excluded from the scope of this International Standard. Tracheal tubes intended for use with flammable anesthetic gases or agents and lasers or electrosurgical devices are not covered by this International Standard.

EN ISO 5361:2016 Referenced Document

  • ASTM D3002-07 Standard Guide for Evaluation of Coatings Applied to Plastics*2024-04-20 Update
  • ASTM F1242-96 Standard Specification for Cuffed and Uncuffed Tracheal Tubes
  • ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use*2024-04-20 Update
  • EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*2024-04-20 Update
  • IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11990-1:2011 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft
  • ISO 11990-2:2010 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs
  • ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 14408:2005 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
  • ISO 14971:2007 Medical devices - Application of risk management to medical devices
  • ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
  • ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary
  • ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
  • ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
  • ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
  • ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway

EN ISO 5361:2016 history

  • 2023 EN ISO 5361:2023 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023)
  • 2016 EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors
  • 2012 EN ISO 5361:2012 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (Incorporating corrigendum December 2012)



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