CSA Z5361 : 2003

Superseded

View Superseded by

ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS

Available format(s)

Hardcopy , PDF

Superseded date

01-02-2014

Language(s)

English

Published date

01-01-2003

Publisher

Canadian Standards Association

1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for tracheal tubes and tracheal
  tube connectors
  4.1 Size designation
  4.2 Dimensions
  4.3 Materials
  4.4 Bevel
  4.5 Cuff
  4.6 Inflating tubes for cuffs
  4.7 Curvature of tube
5 Additional requirements for tracheal tubes with a Murphy eye
  5.1 Size of the Murphy eye
  5.2 Location of the Murphy eye
6 Requirements for tracheal tubes with tracheal tube connector
  supplied sterile
  6.1 Sterility assurance
  6.2 Packaging for tracheal tubes and tracheal tube connectors
      supplied sterile
7 Marking
  7.1 Use of symbols
  7.2 Tracheal tubes
  7.3 Tracheal tube connectors
Annex A (normative) Determination of cuff resting diameter
Annex B (normative) Test method for tube collapse
Annex C (normative) Test method for cuff herniation
Annex D (informative) Guidance on materials and design
Bibliography

Specifies requirements for the dimensions, basic properties and method of size designation of the most commonly used types of oro-tracheal and naso-tracheal tube made of plastics materials and/or rubber (plain and cuffed), and requirements for tracheal tube connectors.

DocumentType	Standard
Pages	40
PublisherName	Canadian Standards Association
Status	Superseded
SupersededBy	CSA ISO 5361 : 2014
Supersedes	CSA Z5361 : 1994 CSA Z168.1 : M83

Standards	Relationship
ISO 5361:2016	Identical
ISO 5361-3:1984	Identical
ISO 5361-5:1984	Identical
ISO 5361-1:1988	Identical
ISO 5361-2:1993	Identical

EN 556:1994 + A1:1998	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
ISO 5356-1:2015	Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
EN 1041:2008+A1:2013	Information supplied by the manufacturer of medical devices
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11607:2003	Packaging for terminally sterilized medical devices
ISO/TR 11991:1995	Guidance on airway management during laser surgery of upper airway
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 4135:2001	Anaesthetic and respiratory equipment Vocabulary
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

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CSA Z5361 : 2003

ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory