Name: UNI EN ISO 5361 : 2013
Brand: UNI

UNI EN ISO 5361 : 2013

Superseded

View Superseded by

ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS

Superseded date

12-09-2022

Published date

01-01-2013

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for tracheal tubes and
  tracheal tube connectors
5 Specific requirements for tracheal tubes and
  tracheal tube connectors
6 Additional requirement for tracheal tubes
  with a Murphy eye
7 Requirements for tracheal tubes with tracheal
  tube connectors supplied sterile
8 Marking
Annex A (informative) - Rationale
Annex B (normative) - Determination of cuff
        diameter
Annex C (normative) - Test method for cuffed
        tube collapse
Annex D (normative) - Test method for cuff
        herniation
Annex E (informative) - Guidance on design of
        tracheal tube connectors
Annex F (informative) - Hazard identification
        for risk assessment
Annex G (normative) - Test method for tracheal
        seal
Annex H (normative) - Test method to determine
        kink resistance
Bibliography
Annex ZA (informative) - Relationship between this
        European Standard and the Essential
        Requirements of EU Directive 93/42/EEC

Gives essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors.

DevelopmentNote	Supersedes UNI EN 1782. (02/2013)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 5361:2016
Supersedes	UNI EN 1782 : 2009

Standards	Relationship
EN ISO 5361:2016	Identical
ISO 5361:2016	Identical

ISO 11990-1:2011	Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft
ISO 14408:2016	Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
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 11990-2:2010	Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs
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 5356-1:2015	Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ANSI Z79.16 : 1983	CUFFED OROTRACHEAL AND NASOTRACHEAL TUBES FOR PROLONGED USE,
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO/TR 11991:1995	Guidance on airway management during laser surgery of upper airway
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 4135:2001	Anaesthetic and respiratory equipment Vocabulary
ASTM F 1242 : 1996 : EDT 1	Standard Specification for Cuffed and Uncuffed Tracheal Tubes (Withdrawn 2002)
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 980:2008	Symbols for use in the labelling of medical devices
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
ASTM F 640 : 2012 : REDLINE	Standard Test Methods for Determining Radiopacity for Medical Use