BS 1695-2:1990
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Urological catheters Specification for sterile, single-use urethral catheters of the Tiemann, whistle tip, 3-way and haematuria types
Hardcopy , PDF
15-07-1997
English
30-09-1990
Committees responsible
Foreword
Specification
1 Scope
2 Definitions
3 Finish
4 Freedom from particulate contamination
5 Gauge size
6 Tip
7 Drainage eyes
8 Balloon
9 Shaft
10 Funnels
11 Marking of catheters
12 Packaging
13 Marking of packages
14 Biological hazard
Appendices
A Guidance on design and materials
B Summary of schedule of performance tests
C Method for determining gauge size of catheter
D Method for determining the security of the tip to
the shaft of the catheter
E Method for determining occlusion of drainage eyes
and leakage from balloon
F Method for determining inflation lumen leakage and/
or valve function and/or balloon deflation
G Method for determining flow rate of drainage and
irrigation lumen
H Method for determining the resistance of the
drainage lumen of haematuria catheters to collapse
or too occlusion under reduced pressure
J Method for determining the integrity of the junction
between the drainage funnel and the shaft of the
catheter
K Method for determining the security of fit of the
drainage funnel
L Method for determining the integrity of the junction
between the inflation funnel and the shaft of the
catheter
M Method for determining the security of fit of the
irrigation funnel
N Symbol for 'Do not re-use'
P Method for determining the toxicity of catheters to
cells in culture
Tables
1 Range of catheter sizes
2 Balloon test volume percentage recovery
3 Balloon capacities
4 Tip lengths
5 Shaft and funnel dimensions
6 Average flow rates
7 Requirements for load test
8 Balloon test capacities
9 Conditions for preparing extracts for cytotoxicity
testing
Figures
1 Typical Tiemann catheter without balloon
2 Typical Tiemann catheter with balloon
3 Typical whistle tip catheter without balloon
4 Typical whistle tip catheter with balloon
5 Typical 3-way catheter with balloon
6 Typical haematuria catheter with balloon
7 Typical cross-sectional configurations of catheter
shaft and designation of lumen dimensions
8 Apparatus and general arrangement for testing
security of catheter tip
9 Apparatus for flow rate test
10 Apparatus and general arrangement for test of
resistance of the drainage lumen of haematuria
catheters to collapse or occlusion under reduced
pressure
11 Test connector and general arrangement for testing
security of fit of the drainage funnel
12 General arrangement for testing the integrity of the
junction between the inflation and irrigation
funnels and the shaft of the catheter
13 ISO symbol 'Do not re-use', Registration No. ISO
7000/1051
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