I.S. EN 1616:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
23-07-2013
English
01-01-1997
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
1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Symbols and labelling
Annex A (normative) Test method for determining the
strength of the catheter
Annex B (normative) Test method for determining the
security of the drainage funnel
Annex C Test method for determination balloon security
Annex D (normative) Test method for determining inflation
lumen leakage and/or function and/or balloon deflation
Annex E (informative) Bibliography
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