ISO 5367:2014
Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 5367:2014 specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer's instructions.
ISO 5367:2014 is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Risk management
4.2 Usability
4.3 Clinical evaluation
4.4 Biophysical or modelling research
4.5 Test methods
4.6 Recommended service life
5 Specific requirements
5.1 Materials
5.2 Length
5.3 Means of connection
5.4 Leakage
5.5 Resistance to flow
5.6 Compliance
6 Prevention of electrostatic charges
7 Requirements for breathing sets and breathing tubes supplied sterile
7.1 Sterility assurance
7.2 Packaging of breathing sets and breathing tubes supplied sterile
8 Marking
8.1 General
8.2 Marking of breathing sets and breathing tubes
8.3 Marking of packages
8.4 Information to be supplied by the manufacturer
Annex A (informative) Rationale
Annex B (informative) Hazard identification for risk assessment
Annex C (normative) Test for security of attachment of plain end to conical connector
Annex D (normative) Test for security of attachment of adaptor to breathing tube
Annex E (normative) Test for leakage
Annex F (normative) Measurement of resistance to flow
Annex G (normative) Test for increase in flow resistance with bending
Annex H (normative) Test for compliance
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Risk management
4.2 Usability
4.3 Clinical evaluation
4.4 Biophysical or modelling research
4.5 Test methods
4.6 Recommended service life
5 Specific requirements
5.1 Materials
5.2 Length
5.3 Means of connection
5.4 Leakage
5.5 Resistance to flow
5.6 Compliance
6 Prevention of electrostatic charges
7 Requirements for breathing sets and breathing tubes supplied sterile
7.1 Sterility assurance
7.2 Packaging of breathing sets and breathing tubes supplied sterile
8 Marking
8.1 General
8.2 Marking of breathing sets and breathing tubes
8.3 Marking of packages
8.4 Information to be supplied by the manufacturer
Annex A (informative) Rationale
Annex B (informative) Hazard identification for risk assessment
Annex C (normative) Test for security of attachment of plain end to conical connector
Annex D (normative) Test for security of attachment of adaptor to breathing tube
Annex E (normative) Test for leakage
Annex F (normative) Measurement of resistance to flow
Annex G (normative) Test for increase in flow resistance with bending
Annex H (normative) Test for compliance
Bibliography