BS 1695-1:1990

Superseded

View Superseded by

Urological catheters Specification for sterile, single-use urethral catheters of the Nélaton and Foley types

Available format(s)

Hardcopy , PDF

Superseded date

15-07-1997

Language(s)

English

Published date

28-09-1990

Publisher

British Standards Institution

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 Method for determining gauge size of catheter
C Method for determining the security of the tip to
    the shaft of the catheter
D Method for determining occlusion of drainage eyes
    and leakage from balloon
E Method for determining inflation lumen leakage and/
    or valve function and/or balloon deflation
F Method for determining flow rate of drainage lumen
G Method for determining the integrity of the junction
    between the drainage funnel and the shaft of the
    catheter
H Method for determining the security of fit of the
    drainage funnel
J Method for determining the integrity of the junction
    between the inflation funnel and the shaft of the
    catheter
K Symbol for 'Do not re-use'
L 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 Nelaton catheter
2 Typical Foley catheter
3 Typical cross-sectional configurations of catheter
    shaft and designation of lumen dimensions
4 Apparatus and general arrangement for testing
    security of catheter tip
5 Apparatus for flow rate test
6 Test connector and general arrangement for testing
    security of fit of the drainage funnel
7 General arrangement for testing the integrity of the
    junction between the inflation funnel and the shaft
    of the catheter
8 ISO symbol 'Do not re-use' Registration No. ISO
    7000/1051

Dimensional and performance requirements for Nélaton and Foley urethral catheters of sizes from 8Ch (2.66 mm) to 30Ch (10 mm).

Committee	CH/84
DocumentType	Standard
Pages	30
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN 1616:1997
Supersedes	BS 1695-1:1986

BS 5736-6:1983	Evaluation of medical devices for biological hazards Methods of test for sensitization; assessment of the potential of medical devices to produce delayed contact dermatitis
BS 5736-10:1988	Evaluation of medical devices for biological hazards Method of test for toxicity to cells in culture of extracts from medical devices
ISO 3461:1976	Graphic symbols — General principles for presentation
BS 5736-4:1981	Evaluation of medical devices for biological hazards Method of test for intracutaneous reactivity of extracts from medical devices
BS 5404-2:1977	Specification for plastics laboratory ware Graduated measuring cylinders
BS 1695-2:1990	Urological catheters Specification for sterile, single-use urethral catheters of the Tiemann, whistle tip, 3-way and haematuria types
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
BS 3930-1(1987) : AMD 8072	CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND OTHER MEDICAL EQUIPMENT - SPECIFICATION FOR GENERAL REQUIREMENTS