EN 1616:1997/A1:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILE URETHRAL CATHETERS FOR SINGLE USE
16-03-2022
12-01-2013
Committees responsible
National foreword
Foreword
1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Symbols and labelling
Annexes
A (normative) Test method for determining the strength
of the catheter
B (normative) Test method for determining the security of
fit of the drainage funnel
C (normative) Test method for determining balloon
security
D (normative) Test method for determining inflation lumen
leakage and/or function and/or balloon deflation
E (informative) Bibliography
Tables
1 Shaft dimensions
2 Average flow rates
C.1 Requirements for load test
D.1 Balloon test capacities
D.2 Balloon test volume percentage recovery
Figures
1 Typical urethral catheters a) without and b) with
balloon
A.1 Apparatus and general arrangement for testing
catheters' strength
B.1 Test connector and general arrangement for
testing security of fit of the drainage funnel
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