ISO 5359:2014
Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 5359:2014 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures of the gases listed above, oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools, and for use with vacuum. It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. It does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.It does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.Nor does it specify the intended uses of hose assemblies.
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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 investigation
4.4 Safety
4.5 Materials
4.6 Design requirements
4.7 Constructional requirements
5 Test methods
5.1 General
5.2 Test method for pressure drop
5.3 Test method for leakage
5.4 Test method for gas specificity
5.5 Test method for mechanical strength
5.6 Test method for deformation under pressure
5.7 Test method for resistance to occlusion
5.8 Test method for durability of markings and colour coding
6 Marking, colour coding and packaging
6.1 Marking
6.2 Colour coding
6.3 Packaging
7 Information to be supplied by the manufacturer
Annex A (informative) Rationale
Annex B (informative) Environmental aspects
Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases
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 investigation
4.4 Safety
4.5 Materials
4.6 Design requirements
4.7 Constructional requirements
5 Test methods
5.1 General
5.2 Test method for pressure drop
5.3 Test method for leakage
5.4 Test method for gas specificity
5.5 Test method for mechanical strength
5.6 Test method for deformation under pressure
5.7 Test method for resistance to occlusion
5.8 Test method for durability of markings and colour coding
6 Marking, colour coding and packaging
6.1 Marking
6.2 Colour coding
6.3 Packaging
7 Information to be supplied by the manufacturer
Annex A (informative) Rationale
Annex B (informative) Environmental aspects
Annex C (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases
Bibliography