BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sterile urethral catheters for single use
21-02-2019
15-08-1999
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.
| Committee |
CH/84
|
| DevelopmentNote |
Supersedes BS 1695-1(1990), BS 1695-2(1990), 94/506464 DC and 98/563030 DC. (05/2005) Reviewed and confirmed by BSI, November 2007. (10/2007)
|
| DocumentType |
Standard
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN 1616 : 1997 AMD 1 1999 | Identical |
| NS EN 1616 : 97 AMD 1 99 | Identical |
| DIN EN 1616:1999-05 | Identical |
| NEN EN 1616 : 1997 AMD 1 1999 | Identical |
| NF EN 1616 : 97 AMD 1 99 | Identical |
| UNE-EN 1616:1997 | Identical |
| UNI EN 1616 : 1997 | Identical |
| SN EN 1616 : 1997 AMD 1 1999 | Identical |
| I.S. EN 1616:1997 | Identical |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
| BS EN 1618:1997 | Catheters other than intravascular catheters. Test methods for common properties |
| BS EN 556:1995 | Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\' |
| BS EN 20594-1:1994 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment General requirements |
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