CSA Z5361 : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
Hardcopy , PDF
01-02-2014
English
01-01-2003
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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Superseded
|
| Supersedes |
| 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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