ISO 5361:2016
Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 5361:2016 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.
Endobronchial (including tracheobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are excluded from the scope of ISO 5361:2016.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of ISO 5361:2016.
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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
4.1 Risk assessment
4.2 Safety
5 Specific requirements for tracheal tubes and tracheal tube connectors
5.1 Size designation
5.2 Dimensions
5.2.1 Tracheal tubes
5.2.2 Tracheal tube connectors
5.3 *Materials
5.4 Tracheal tube bevel
5.5 *Tracheal tube cuffs
5.6 Inflating system for cuffs
5.7 Curvature of the tube
5.8 *Radiopaque marker
5.9 *Kink resistance
6 Additional requirement for tracheal tubes with a Murphy eye
6.1 Size of the Murphy eye
6.2 Location of the Murphy eye
6.3 Resistance to kinking or collapse of the Murphy eye
6.4 Surface characteristics of the Murphy eye
7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile
7.1 Sterility assurance
7.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile
8 Marking
8.1 Use of symbols
8.2 Marking on the tracheal tube
8.3 Marking on the tracheal tube individual pack or any insert
8.4 Marking on tracheal tube connectors
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
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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
4.1 Risk assessment
4.2 Safety
5 Specific requirements for tracheal tubes and tracheal tube connectors
5.1 Size designation
5.2 Dimensions
5.2.1 Tracheal tubes
5.2.2 Tracheal tube connectors
5.3 *Materials
5.4 Tracheal tube bevel
5.5 *Tracheal tube cuffs
5.6 Inflating system for cuffs
5.7 Curvature of the tube
5.8 *Radiopaque marker
5.9 *Kink resistance
6 Additional requirement for tracheal tubes with a Murphy eye
6.1 Size of the Murphy eye
6.2 Location of the Murphy eye
6.3 Resistance to kinking or collapse of the Murphy eye
6.4 Surface characteristics of the Murphy eye
7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile
7.1 Sterility assurance
7.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile
8 Marking
8.1 Use of symbols
8.2 Marking on the tracheal tube
8.3 Marking on the tracheal tube individual pack or any insert
8.4 Marking on tracheal tube connectors
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