EN 1820:2005+A1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Anaesthetic reservoir bags (ISO 5362:2000, modified)
08-03-2022
12-08-2009
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 results
Annex B (normative) - Determination of capacity
B.1 Principle
B.2 Apparatus
B.3 Procedure
B.4 Expression of results
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.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 results
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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