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

Standard No.
BS EN ISO 5361:2016
Release Date
2016
Published By
British Standards Institution (BSI)
Status
 2023-02
Replace By
BS EN ISO 5361:2023
Latest
BS EN ISO 5361:2023
Replace
BS EN ISO 5361:2012

BS EN ISO 5361:2016 Referenced Document

  • ASTM D3002-07 Standard Guide for Evaluation of Coatings Applied to Plastics*2023-12-21 Update
  • ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use*2023-12-21 Update
  • 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*2023-12-21 Update
  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*2018-08-01 Update
  • ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne*2023-12-21 Update
  • 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*2018-11-08 Update
  • ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
  • 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 Clinical investigation of medical devices for human subjects — Good clinical practice*2020-07-28 Update
  • 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 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1
  • 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 4135 Anaesthesiology — Vocabulary*2022-01-19 Update
  • 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*2019-07-12 Update
  • ISO/TR 11991:1995 Guidance on airway management during laser surgery of upper airway

BS EN ISO 5361:2016 history




Copyright ©2023 All Rights Reserved