Anaesthetic reservoir bags (ISO 5362:2000, modified)
DIN EN 1820:2009-12 (E)
Anaesthetic reservoir bags (ISO 5362:2000, modified) (includes Amendment A1:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….4
Introduction ……………………………………………………………………………………………………………………………………5
1 Scope ……………………………………………………………………………………………………………………………..6
2 Normative references ……………………………………………………………………………………………………..6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General requirements ……………………………………………………………………………………………………..7
5 Prevention of electrostatic charges …………………………………………………………………………………9
6 Requirements for bags supplied sterile ……………………………………………………………………………9
7 Marking …………………………………………………………………………………………………………………………..9
8 Information to be supplied by the manufacturer …………………………………………………………….10
Annex A (informative) Test for leakage ………………………………………………………………………………………….11
A.1 Principle ……………………………………………………………………………………………………………………….11
A.2 Apparatus ……………………………………………………………………………………………………………………..11
A.3 Procedure ……………………………………………………………………………………………………………………..11
A.4 Expression of results …………………………………………………………………………………………………….11
Annex B (normative) Determination of capacity …………………………………………………………………………….12
B.1 Principle ……………………………………………………………………………………………………………………….12
B.2 Apparatus ……………………………………………………………………………………………………………………..12
B.3 Procedure ……………………………………………………………………………………………………………………..12
B.4 Expression of results …………………………………………………………………………………………………….12
Annex C (normative) Test for security of attachment of plain neck to 22 mm male conical
connector 13 C.1 Principle …………………………………………………………………………………………….13
C.2 Apparatus and materials ……………………………………………………………………………………………….13
C.3 Procedure ……………………………………………………………………………………………………………………..13
Annex D (normative) Test for security of attachment of adaptor of assembled neck to bag ……………14
D.2 Apparatus ……………………………………………………………………………………………………………………..14
D.3 Procedure ……………………………………………………………………………………………………………………..14
Annex E (normative) Test for resistance to pressure required to distend the bag
(pressure/volume). 15 E.1 Principle ……………………………………………………………………………….15
E.2 Apparatus ……………………………………………………………………………………………………………………..15
E.3 Procedure ……………………………………………………………………………………………………………………..15
E.4 Expression of results …………………………………………………………………………………………………….15
Annex F (informative) Test for resistance to pressure required to distend the bag using air
(pressure/volume) ……………………………………………………………………………………………………….. 16
F.1 Principle ………………………………………………………………………………………………………………………. 16
F.2 Apparatus ……………………………………………………………………………………………………………………. 16
F.3 Procedure ……………………………………………………………………………………………………………………. 16
F.4 Expression of results …………………………………………………………………………………………………… 16
Annex G (informative) Recommendations for materials ……………………………………………………………….. 17
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices …………………………………………….. 18
Bibliography ……………………………………………………………………………………………………………………………….. 20