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