AS/NZS 2696:1996
Medical devices - Polymer urethral catheters for general medical use
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.
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AS/NZS 2696:1996 MEDICAL DEVICES-POLYMER URETHRAL CATHETERS FOR GENERAL MEDICAL USE
PREFACE
CONTENTS
1 SCOPE
2 REFERENCED DOCUMENTS
3 CLASSIFICATION
4 DEFINITIONS
4.1 Balloon
4.2 Drainage eye
4.3 Free end
4.4 French gauge
4.5 Lumen
4.6 Multiple pack
4.7 Rated capacity of balloon
4.8 Shaft
4.9 ‘Shall’ ‘Should’ and ‘May’
4.9.1 Shall
4.9.2 Should
4.9.3 May
4.10 Single-use
4.11 Size
4.12 Sterile
4.13 Store pack
4.14 Tip end
4.15 Unit
4.16 Unit pack
4.17 Urethral catheter
5 SIZE
6 MATERIALS
6.1 General
6.2 Rigidity
6.3 Deformation during storage
6.4 Compatibility
6.4.1 Effect of body fluids on catheter
6.4.2 Effect of catheter on body tissues
6.4.3 Compatibility of catheter with treatment fluids
6.4.4 Sterility
7 DESIGN AND CONSTRUCTION—GENERAL REQUIREMENTS
7.1 Drainage lumen
7.2 Drainage eyes
7.2.1 Types I and II catheters
7.2.2 Type III catheter
7.3 Free end (funnel end)
7.4 Finish
8 SPECIFIC REQUIREMENTS ACCORDING TO TYPE
8.1 Urethral catheters without balloons (Type1and Type III)
8.1.1 General
8.1.2 Length
8.1.3 Dimensions
8.1.4 Tip position
8.1.5 Flow rate
8.2 Urethral catheters with balloons (Type II and Type III)
8.2.1 General
8.2.2 Length
8.2.3 Dimensions
8.2.4 Balloon symmetry
8.2.5 Restriction of flow due to inflated balloon
8.2.6 Tip position
8.2.7 Balloon performance
8.2.8 Inflating tube
8.2.9 Non-return valve
9 PACKAGING
9.1 Unit pack
9.2 Multiple pack
9.3 Store pack
10 MARKING
10.1 On catheters with balloons
10.2 On the unit pack
10.3 On the multiple pack
APPENDIX A - METHOD FOR DETERMINING CATHETER BALLOON PERFORMANCE, FLOW RATE AND IN-USE COMPATIBILITY
A1 SCOPE
A2 PRINCIPLE
A3 REAGENTS
A4 APPARATUS
A5 PROCEDURE
A5.1 Type I or Type III catheters
A5.2 Type II and Type III catheters
A6 CALCULATION
A6.1 Type I and Type III catheters
A6.2 Type II and Type III catheters
A7 REPORT
A7.1 Type I and Type III catheters
A7.2 Type II and Type III catheters
APPENDIX B - METHOD OF TESTING CATHETERS FOR CYTOTOXICITY
B1 SCOPE
B2 DEFINITIONS
B2.1 Cytotoxic titre
B2.2 Positive control
B2.3 Negative control
B3 PRINCIPLE
B4 REAGENTS
B4.1 General
B4.2 Hanks' balanced salt solution (HBSS)
B4.3 Hanks' balanced salt solution, without calcium and magnesium
B4.4 Trypsin solution, 0.00125 g/mL
B4.5 Culture medium
B4.6 Growth medium
B4.7 Extraction medium
B4.8 Neutral red solution (vital stain)
B4.9 Formalin-crystal violet solution
B4.10 Positive control
B4.11 Negative control
B5 APPARATUS
B6 PREPARATION OF CULTURE CELLS
B6.1 VERO cells
B6.2 Cell maintenance
B6.3 Cell subculture
B6.4 Preparation of cell monolayer in culture test plates
B7 TOXICITY TESTING OF EXTRACTS OF TEST AND CONTROL MATERIALS
B7.1 Preparation of extracts
B7.2 Toxicity test
B7.3 Assessment of toxicity
B8 INTERPRETATION OF TEST RESULTS
B9 REPORT
Amendments
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AS/NZS 2696:1996 MEDICAL DEVICES-POLYMER URETHRAL CATHETERS FOR GENERAL MEDICAL USE
PREFACE
CONTENTS
1 SCOPE
2 REFERENCED DOCUMENTS
3 CLASSIFICATION
4 DEFINITIONS
4.1 Balloon
4.2 Drainage eye
4.3 Free end
4.4 French gauge
4.5 Lumen
4.6 Multiple pack
4.7 Rated capacity of balloon
4.8 Shaft
4.9 ‘Shall’ ‘Should’ and ‘May’
4.9.1 Shall
4.9.2 Should
4.9.3 May
4.10 Single-use
4.11 Size
4.12 Sterile
4.13 Store pack
4.14 Tip end
4.15 Unit
4.16 Unit pack
4.17 Urethral catheter
5 SIZE
6 MATERIALS
6.1 General
6.2 Rigidity
6.3 Deformation during storage
6.4 Compatibility
6.4.1 Effect of body fluids on catheter
6.4.2 Effect of catheter on body tissues
6.4.3 Compatibility of catheter with treatment fluids
6.4.4 Sterility
7 DESIGN AND CONSTRUCTION—GENERAL REQUIREMENTS
7.1 Drainage lumen
7.2 Drainage eyes
7.2.1 Types I and II catheters
7.2.2 Type III catheter
7.3 Free end (funnel end)
7.4 Finish
8 SPECIFIC REQUIREMENTS ACCORDING TO TYPE
8.1 Urethral catheters without balloons (Type1and Type III)
8.1.1 General
8.1.2 Length
8.1.3 Dimensions
8.1.4 Tip position
8.1.5 Flow rate
8.2 Urethral catheters with balloons (Type II and Type III)
8.2.1 General
8.2.2 Length
8.2.3 Dimensions
8.2.4 Balloon symmetry
8.2.5 Restriction of flow due to inflated balloon
8.2.6 Tip position
8.2.7 Balloon performance
8.2.8 Inflating tube
8.2.9 Non-return valve
9 PACKAGING
9.1 Unit pack
9.2 Multiple pack
9.3 Store pack
10 MARKING
10.1 On catheters with balloons
10.2 On the unit pack
10.3 On the multiple pack
APPENDIX A - METHOD FOR DETERMINING CATHETER BALLOON PERFORMANCE, FLOW RATE AND IN-USE COMPATIBILITY
A1 SCOPE
A2 PRINCIPLE
A3 REAGENTS
A4 APPARATUS
A5 PROCEDURE
A5.1 Type I or Type III catheters
A5.2 Type II and Type III catheters
A6 CALCULATION
A6.1 Type I and Type III catheters
A6.2 Type II and Type III catheters
A7 REPORT
A7.1 Type I and Type III catheters
A7.2 Type II and Type III catheters
APPENDIX B - METHOD OF TESTING CATHETERS FOR CYTOTOXICITY
B1 SCOPE
B2 DEFINITIONS
B2.1 Cytotoxic titre
B2.2 Positive control
B2.3 Negative control
B3 PRINCIPLE
B4 REAGENTS
B4.1 General
B4.2 Hanks' balanced salt solution (HBSS)
B4.3 Hanks' balanced salt solution, without calcium and magnesium
B4.4 Trypsin solution, 0.00125 g/mL
B4.5 Culture medium
B4.6 Growth medium
B4.7 Extraction medium
B4.8 Neutral red solution (vital stain)
B4.9 Formalin-crystal violet solution
B4.10 Positive control
B4.11 Negative control
B5 APPARATUS
B6 PREPARATION OF CULTURE CELLS
B6.1 VERO cells
B6.2 Cell maintenance
B6.3 Cell subculture
B6.4 Preparation of cell monolayer in culture test plates
B7 TOXICITY TESTING OF EXTRACTS OF TEST AND CONTROL MATERIALS
B7.1 Preparation of extracts
B7.2 Toxicity test
B7.3 Assessment of toxicity
B8 INTERPRETATION OF TEST RESULTS
B9 REPORT
Amendments
AS/NZS 2696:1996
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.