Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
Abstract
ISO 5359:2008 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;
- vacuum.
It is intended in particular to ensure gas-specificity and to prevent cross-connection between systems conveying different gases. These hoses assemblies are intended for use at maximum operating pressures less than 1 400 kPa.
ISO 5359:2008 specifies the allocation of non-interchangeable screw-threaded (NIST) connectors, diameter-index safety system (DISS) connectors and sleeve indexed system (SIS) connectors to medical gases and specifies the dimensions of non-interchangeable screw-threaded (NIST) connectors.
DIN EN ISO 5359:2012-04 (E)
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008 + Amd
1:2011) (includes Amendment A1:2011)
Contents Page
Introduction …………………………………………………………………………………………………………………………………… 6
0.1 General ………………………………………………………………………………………………………………………….. 6
0.2 Standardization of screw-threaded connectors for use in hose assemblies …………………….. 6
1 Scope …………………………………………………………………………………………………………………………….. 8
2 Normative references …………………………………………………………………………………………………….. 9
3 Terms and definitions …………………………………………………………………………………………………….. 9
4 General requirements …………………………………………………………………………………………………… 12
4.1 Safety …………………………………………………………………………………………………………………………… 12
4.2 * Alternative construction …………………………………………………………………………………………….. 13
4.3 Materials ………………………………………………………………………………………………………………………. 13
4.4 Design requirements …………………………………………………………………………………………………….. 13
4.4.1 Hose internal diameter …………………………………………………………………………………………………. 13
4.4.2 Mechanical strength ……………………………………………………………………………………………………… 13
4.4.3 Deformation under pressure …………………………………………………………………………………………. 14
4.4.4 Resistance to occlusion ……………………………………………………………………………………………….. 14
4.4.5 Adhesion strength ………………………………………………………………………………………………………… 14
4.4.6 Flexibility ……………………………………………………………………………………………………………………… 14
4.4.7 Gas-specificity ……………………………………………………………………………………………………………… 14
4.4.8 End connectors ……………………………………………………………………………………………………………. 15
4.4.9 Design of NIST connectors …………………………………………………………………………………………… 15
4.4.10 Design of DISS connectors …………………………………………………………………………………………… 15
4.4.11 Design of SIS connectors ……………………………………………………………………………………………… 23
4.4.12 Joining hoses to hose inserts ………………………………………………………………………………………. 23
4.4.13 Leakage ……………………………………………………………………………………………………………………….. 24
4.4.14 * Pressure drop …………………………………………………………………………………………………………….. 24
4.4.15 Expulsion of nipple ………………………………………………………………………………………………………. 24
4.5 Constructional requirements ………………………………………………………………………………………… 24
4.5.1 * Cleaning …………………………………………………………………………………………………………………….. 24
4.5.2 * Lubricants ………………………………………………………………………………………………………………….. 25
5 Test methods ……………………………………………………………………………………………………………….. 25
5.1 General ………………………………………………………………………………………………………………………… 25
5.1.1 Ambient conditions ………………………………………………………………………………………………………. 25
5.1.2 Test gas ……………………………………………………………………………………………………………………….. 25
5.1.3 Reference conditions ……………………………………………………………………………………………………. 25
5.2 Test method for pressure drop ……………………………………………………………………………………… 25
5.3 Test method for leakage ……………………………………………………………………………………………….. 25
5.3.1 For all hose assemblies ………………………………………………………………………………………………… 25
5.3.2 For hose assemblies fitted with a hose assembly check valve ………………………………………. 25
5.4 Test method for gas-specificity …………………………………………………………………………………….. 25
5.5 Test method for mechanical strength ……………………………………………………………………………. 26
5.6 Test method for deformation under pressure ………………………………………………………………… 26
5.7 Test method for resistance to occlusion ……………………………………………………………………….. 26
5.8 Test method for durability of markings and colour coding …………………………………………….. 28
6 Marking, colour coding and packaging …………………………………………………………………………. 28
6.1 Marking ……………………………………………………………………………………………………………………….. 28
6.2 Colour coding ……………………………………………………………………………………………………………… 29
6.3 Packaging ……………………………………………………………………………………………………………………. 29
7 Information to be supplied by the manufacturer ……………………………………………………………. 29
Annex A (informative) Rationale ………………………………………………………………………………………………….. 31
Annex B (informative) Environmental aspects ……………………………………………………………………………… 32
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases …………………………………………………………………………………… 33
Bibliography ……………………………………………………………………………………………………………………………….. 35
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………… 36