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BS EN ISO 20696:2018 Sterile urethral catheters for single use, 2020
- undefined
- European foreword
- Endorsement notice
- 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 [Go to Page]
