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NS EN 1616 : 97 AMD 1 99

Current
Current

The latest, up-to-date edition.

STERILE URETHAL CATHETERS FOR SINGLE USE
Published date

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

Defines requirements for sterile, single-use urethral catheters with and without balloons.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Current

Standards Relationship
UNE-EN 1616:1997 Identical
EN 1616:1997/A1:1999 Identical
SN EN 1616 : 1997 AMD 1 1999 Identical
UNI EN 1616 : 1997 Identical
I.S. EN 1616:1997 Identical
DIN EN 1616:1999-05 Identical

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