AS/NZS 2696:1996

1 - AS/NZS 2696:1996 MEDICAL DEVICES-POLYMER URETHRAL CATHETERS FOR GENERAL MEDICAL USE
4 - PREFACE
5 - CONTENTS
6 - 1 SCOPE
6 - 2 REFERENCED DOCUMENTS
6 - 3 CLASSIFICATION
7 - 4 DEFINITIONS
7 - 4.1 Balloon
7 - 4.2 Drainage eye
7 - 4.3 Free end
7 - 4.4 French gauge
7 - 4.5 Lumen
7 - 4.6 Multiple pack
7 - 4.7 Rated capacity of balloon
7 - 4.8 Shaft
7 - 4.9 ‘Shall’ ‘Should’ and ‘May’
7 - 4.9.1 Shall
7 - 4.9.2 Should
7 - 4.9.3 May
7 - 4.10 Single-use
7 - 4.11 Size
7 - 4.12 Sterile
7 - 4.13 Store pack
7 - 4.14 Tip end
7 - 4.15 Unit
7 - 4.16 Unit pack
7 - 4.17 Urethral catheter
7 - 5 SIZE
8 - 6 MATERIALS
8 - 6.1 General
8 - 6.2 Rigidity
8 - 6.3 Deformation during storage
8 - 6.4 Compatibility
8 - 6.4.1 Effect of body fluids on catheter
8 - 6.4.2 Effect of catheter on body tissues
9 - 6.4.3 Compatibility of catheter with treatment fluids
9 - 6.4.4 Sterility
9 - 7 DESIGN AND CONSTRUCTION-GENERAL REQUIREMENTS
9 - 7.1 Drainage lumen
9 - 7.2 Drainage eyes
9 - 7.2.1 Types I and II catheters
9 - 7.2.2 Type III catheter
10 - 7.3 Free end (funnel end)
10 - 7.4 Finish
10 - 8 SPECIFIC REQUIREMENTS ACCORDING TO TYPE
10 - 8.1 Urethral catheters without balloons (Type1and Type III)
10 - 8.1.1 General
10 - 8.1.2 Length
10 - 8.1.3 Dimensions
10 - 8.1.4 Tip position
10 - 8.1.5 Flow rate
10 - 8.2 Urethral catheters with balloons (Type II and Type III)
10 - 8.2.1 General
10 - 8.2.2 Length
10 - 8.2.3 Dimensions
10 - 8.2.4 Balloon symmetry
11 - 8.2.5 Restriction of flow due to inflated balloon
11 - 8.2.6 Tip position
11 - 8.2.7 Balloon performance
11 - 8.2.8 Inflating tube
11 - 8.2.9 Non-return valve
12 - 9 PACKAGING
12 - 9.1 Unit pack
12 - 9.2 Multiple pack
12 - 9.3 Store pack
12 - 10 MARKING
12 - 10.1 On catheters with balloons
12 - 10.2 On the unit pack
13 - 10.3 On the multiple pack
18 - APPENDIX A - METHOD FOR DETERMINING CATHETER BALLOON PERFORMANCE, FLOW RATE AND IN-USE COMPATIBILITY
18 - A1 SCOPE
18 - A2 PRINCIPLE
18 - A3 REAGENTS
18 - A4 APPARATUS
19 - A5 PROCEDURE
19 - A5.1 Type I or Type III catheters
19 - A5.2 Type II and Type III catheters
20 - A6 CALCULATION
20 - A6.1 Type I and Type III catheters
20 - A6.2 Type II and Type III catheters
20 - A7 REPORT
20 - A7.1 Type I and Type III catheters
20 - A7.2 Type II and Type III catheters
23 - APPENDIX B - METHOD OF TESTING CATHETERS FOR CYTOTOXICITY
23 - B1 SCOPE
23 - B2 DEFINITIONS
23 - B2.1 Cytotoxic titre
23 - B2.2 Positive control
23 - B2.3 Negative control
23 - B3 PRINCIPLE
23 - B4 REAGENTS
23 - B4.1 General
23 - B4.2 Hanks' balanced salt solution (HBSS)
24 - B4.3 Hanks' balanced salt solution, without calcium and magnesium
24 - B4.4 Trypsin solution, 0.00125 g/mL
24 - B4.5 Culture medium
24 - B4.6 Growth medium
24 - B4.7 Extraction medium
24 - B4.8 Neutral red solution (vital stain)
25 - B4.9 Formalin-crystal violet solution
25 - B4.10 Positive control
25 - B4.11 Negative control
25 - B5 APPARATUS
25 - B6 PREPARATION OF CULTURE CELLS
26 - B6.1 VERO cells
26 - B6.2 Cell maintenance
26 - B6.3 Cell subculture
26 - B6.4 Preparation of cell monolayer in culture test plates
26 - B7 TOXICITY TESTING OF EXTRACTS OF TEST AND CONTROL MATERIALS
26 - B7.1 Preparation of extracts
27 - B7.2 Toxicity test
28 - B7.3 Assessment of toxicity
28 - B8 INTERPRETATION OF TEST RESULTS
28 - B9 REPORT

Specifies requirements for polymer urethral catheters, manufactured sterile and non-sterile, and intended to be introduced through the urethra into the urinary bladder. Appendices include methods for determining catheter balloon performance, flow rate, in-use compatibility and cytoxicity.

This Standard specifies requirements for polymer urethral catheters, manufactured sterile and non-sterile, and intended to be introduced through the urethra into the urinary bladder. Catheters supplied non-sterile shall meet the requirements of this Standard, after sterilization using the manufacturer's recommended method.NOTE: Materials to be used for the construction of urethral catheters are not specified in detail as their selection will depend, to some extent, upon the design, process of manufacture and method of sterilization, where appropriate, employed by the individual manufacturers.

First published in Australia as AS 2696-1984.
Second edition 1989.
Jointly revised and redesignated AS/NZS 2696:1996.