EN 13544-3:2001+A1:2009: Respiratory therapy equipment – Part 3: Air entrainment devices
DIN EN 13544-3:2010-01 (E)
Respiratory therapy equipment – Part 3: Air entrainment devices (includes
Amendment A1:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
1 Scope ……………………………………………………………………………………………………………………………..4
2 Normative references ……………………………………………………………………………………………………..4
3 Terms and definition ……………………………………………………………………………………………………….4
3.1 Air entrainment device ……………………………………………………………………………………………………4
4 Oxygen supply ………………………………………………………………………………………………………………..4
5 Connections ……………………………………………………………………………………………………………………4
5.1 Oxygen supply inlet ………………………………………………………………………………………………………..4
5.2 Air inlet attachments ……………………………………………………………………………………………………….5
6 Delivered oxygen concentration ………………………………………………………………………………………5
7 Marking and identification ……………………………………………………………………………………………….5
7.1 Marking …………………………………………………………………………………………………………………………..5
7.2 Colour coding …………………………………………………………………………………………………………………6
8 Information supplied by the manufacturer ……………………………………………………………………….6
9 !Usability ………………………………………………………………………………………………………………………..7
10 Clinical evaluation …………………………………………………………………………………………………………..7
Annex A (normative) Method of test for delivered oxygen concentration …………………………………………8
Annex B (informative) Rationale ……………………………………………………………………………………………………11
Annex C (informative) Colour coding …………………………………………………………………………………………….12
Annex ZA (informative) !Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC” ……………………………………………………………………..13
Bibliography …………………………………………………………………………………………………………………………………14