ISO 20696:2018
Sterile urethral catheters for single use
This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.
This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.
NOTE Ureteral stents are covered in ASTM F1828‑97.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 General requirements
5.1 Risk management
5.2 Biocompatibility
5.3 Detectability
5.4 Surface finish
5.5 Size designation
5.5.1 General
5.5.2 Outer diameter
5.5.3 Effective shaft lengths
5.6 MRI compatibility
5.7 Connector
5.8 Sterilization
6 Specific requirements
6.1 Strength
6.2 Connector security
6.3 Balloon safety
6.4 Catheter inflation lumen integrity and volume maintenance
6.4.1 General
6.4.2 Compliant balloon
6.4.3 Non-compliant balloon
6.5 Flow rate
6.6 Corrosion resistance
6.7 Kink stability
6.8 Peak tensile force
6.9 Inflated balloon resistance to traction
7 Information to be supplied by the manufacturer
7.1 General
7.2 Marking on the device and/or packaging
7.3 Instructions for use
Annex A (normative) Test method for determining the strength of the catheter
Annex B (normative) Test method for determining the security of fit of the drainage funnel
Annex C (normative) Test method for determining balloon safety
Annex D (normative) Test method for determining inflation lumen leakage and/or function and/or balloon deflation (catheter with compliant balloon)
Annex E (normative) Test method for determination of flow rate through catheter
Annex F (normative) Test method for corrosion resistance
Annex G (informative) Test method for determining kink stability
Annex H (normative) Test method for determining peak tensile force of urethral catheter
Annex I (normative) Test method for determining balloon size deflation reliability (catheter with non-compliant balloon)
Annex J (normative) Test method for determining inflated balloon resistance to traction
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 General requirements
5.1 Risk management
5.2 Biocompatibility
5.3 Detectability
5.4 Surface finish
5.5 Size designation
5.5.1 General
5.5.2 Outer diameter
5.5.3 Effective shaft lengths
5.6 MRI compatibility
5.7 Connector
5.8 Sterilization
6 Specific requirements
6.1 Strength
6.2 Connector security
6.3 Balloon safety
6.4 Catheter inflation lumen integrity and volume maintenance
6.4.1 General
6.4.2 Compliant balloon
6.4.3 Non-compliant balloon
6.5 Flow rate
6.6 Corrosion resistance
6.7 Kink stability
6.8 Peak tensile force
6.9 Inflated balloon resistance to traction
7 Information to be supplied by the manufacturer
7.1 General
7.2 Marking on the device and/or packaging
7.3 Instructions for use
Annex A (normative) Test method for determining the strength of the catheter
Annex B (normative) Test method for determining the security of fit of the drainage funnel
Annex C (normative) Test method for determining balloon safety
Annex D (normative) Test method for determining inflation lumen leakage and/or function and/or balloon deflation (catheter with compliant balloon)
Annex E (normative) Test method for determination of flow rate through catheter
Annex F (normative) Test method for corrosion resistance
Annex G (informative) Test method for determining kink stability
Annex H (normative) Test method for determining peak tensile force of urethral catheter
Annex I (normative) Test method for determining balloon size deflation reliability (catheter with non-compliant balloon)
Annex J (normative) Test method for determining inflated balloon resistance to traction
Bibliography