EN ISO 10524-2

Pressure regulators for use with medical gases – Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

DIN EN ISO 10524-2:2006-07 (E)
Pressure regulators for use with medical gases – Part 2: Manifold and line pressure
regulators (ISO 10524-2:2005)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….2
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Symbols …………………………………………………………………………………………………………………………8
5 General requirements ……………………………………………………………………………………………………..8
5.1 Safety ……………………………………………………………………………………………………………………………..8
5.2 Alternative construction ………………………………………………………………………………………………….8
5.3 Materials …………………………………………………………………………………………………………………………8
5.4 Design requirements ……………………………………………………………………………………………………….9
5.5 Constructional requirements …………………………………………………………………………………………13
6 Test methods ………………………………………………………………………………………………………………..13
6.1 Conditions …………………………………………………………………………………………………………………….13
6.2 Test methods for manifold pressure regulators ……………………………………………………………..14
6.3 Test methods for line pressure regulators ……………………………………………………………………..20
6.4 Test method for determination of the auto-ignition temperature of sealing materials and
lubricants ……………………………………………………………………………………………………………………..21
6.5 Test method for durability of markings and colour coding ……………………………………………..22
7 Marking, colour coding, packaging ………………………………………………………………………………..23
7.1 Marking …………………………………………………………………………………………………………………………23
7.2 Colour coding ……………………………………………………………………………………………………………….24
7.3 Packaging …………………………………………………………………………………………………………………….25
8 Information to be supplied by the manufacturer …………………………………………………………….25
Annex A (informative) Examples of pressure regulators ………………………………………………………………..26
Annex B (informative) Rationale ……………………………………………………………………………………………………28
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases ……………………………………………………………………………………30
Bibliography …………………………………………………………………………………………………………………………………32
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices ……………………………………………..33