CSA ISO 5361 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
30-07-2021
English, French
01-01-2014
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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
Describes essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors.
| DevelopmentNote |
Supersedes CSA Z5361. (03/2014)
|
| DocumentType |
Standard
|
| Pages |
60
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| Standards | Relationship |
| 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 |
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