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

Standard No.
EN ISO 5361:2012
Release Date
2012
Published By
European Committee for Standardization (CEN)
Status
Replace By
EN ISO 5361:2016
Latest
EN ISO 5361:2023
Replace
BS EN ISO 5270:2000
Scope
This International Standard provides essential performance and safety requirements for oro-tracheal andnaso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal ornylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioningor monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised forspecialized applications are included inThis International Standard, as many specialized tracheal tubes arenow commonly used, and all share similar essential requirements as defined inThis International Standard.

EN ISO 5361:2012 Referenced Document

  • ASTM D3002-07 Standard Guide for Evaluation of Coatings Applied to Plastics
  • ASTM F640-07 Standard Test Methods for Determining Radiopacity for Medical Use
  • EN 1041 Information supplied by the manufacturer of medical devices
  • EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
  • EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
  • ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
  • ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
  • ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 14971 Medical devices - Application of risk management to medical devices
  • ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
  • ISO 15223-2 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
  • ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
  • ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
  • ISO 7000 Graphical symbols for use on equipment — Index and synopsis

EN ISO 5361:2012 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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