EN ISO 10524-4

Pressure regulators for use with medical gases – Part 4: Low-pressure regulators (ISO 10524-4:2008)

DIN EN ISO 10524-4:2008-09 (E)
Pressure regulators for use with medical gases – Part 4: Low-pressure regulators
(ISO 10524-4:2008)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 * Normative references ……………………………………………………………………………………………………6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Nomenclature …………………………………………………………………………………………………………………8
5 General requirements ……………………………………………………………………………………………………..8
5.1 Safety ……………………………………………………………………………………………………………………………..8
5.2 Alternative construction ………………………………………………………………………………………………….8
5.3 Materials …………………………………………………………………………………………………………………………9
5.4 Design requirements ……………………………………………………………………………………………………….9
5.5 Constructional requirements …………………………………………………………………………………………16
6 Test methods ………………………………………………………………………………………………………………..16
6.1 General …………………………………………………………………………………………………………………………16
6.2 Test conditions ……………………………………………………………………………………………………………..17
6.3 Test method for outlet pressure …………………………………………………………………………………….17
6.4 Test methods for leakage ………………………………………………………………………………………………18
6.5 Test method for mechanical strength …………………………………………………………………………….19
6.6 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
flowgauges ……………………………………………………………………………………………………………………19
6.7 Test method for the stability of flow of pressure regulators fitted with flowmeters or
flowgauges ……………………………………………………………………………………………………………………19
6.8 Test method for stability and accuracy of flow of pressure regulators fitted with fixed
orifices ………………………………………………………………………………………………………………………….19
6.9 Test method for loosening torque ………………………………………………………………………………….19
6.10 Test method for durability of markings and colour coding ……………………………………………..19
7 Marking, colour coding, packaging ………………………………………………………………………………..20
7.1 Marking …………………………………………………………………………………………………………………………20
7.2 Colour coding ……………………………………………………………………………………………………………….21
7.3 Packaging …………………………………………………………………………………………………………………….21
8 Information to be supplied by the manufacturer …………………………………………………………….21
Annex A (informative) Typical examples of low-pressure regulators ……………………………………………..23
Annex B (informative) Rationale ……………………………………………………………………………………………………28
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases ……………………………………………………………………………………30
Annex D (informative) Environmental aspects ………………………………………………………………………………32
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC ……………………………………………………………………………………………………………………. 34
Bibliography ……………………………………………………………………………………………………………………………….. 36