I.S. EN 1820:2005
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
ANAESTHETIC RESERVOIR BAGS
Hardcopy , PDF
03-31-2020
English
01-01-2005
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Prevention of electrostatic charges
6 Requirements for bags supplied sterile
7 Marking
8 Information to be supplied by the manufacturer
Annex A (informative) Test for leakage
A.1 Principle
A.2 Apparatus
A.3 Procedure
A.4 Expression of result
Annex B (normative) Determination of capacity
B.1 Principle
B.2 Apparatus
B.3 Procedure
B.4 Expression of result
Annex C (normative) Test for security of attachment
of plain neck to 22 mm male conical connector
C.1 Principle
C.2 Apparatus and materials
C.3 Procedure
Annex D (normative) Test for security of attachment
of adaptor of assembled neck to bag
D.1 Principle
D.2 Apparatus
D.3 Procedure
Annex E (normative) Test for resistance to pressure
required to distend the bag
(pressure/volume)
E.1 Principle
E.2 Apparatus
E.3 Procedure
E.4 Expression of results
Annex F (informative) Test for resistance to pressure
required to distend the bag using air
(pressure/volume)
F.1 Principle
F.2 Apparatus
F.3 Procedure
F.4 Expression of result
Annex G (informative) Recommendations for materials
Annex ZA (informative) Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42/EEC Medical devices
Bibliography
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