Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 General requirements
6 Specific requirements
7 Information supplied by the manufacturer
Annex A (informative) - Test method for determining
kink stability
Annex B (normative) - Test method for corrosion resistance
Annex C (normative) - Test method for resistance to
deformation by suction
Annex D (normative) - Test method for determining peak
tensile force of connectors
Annex E (normative) - Test method for determining peak
tensile force of drainage catheter
Annex F (normative) - Test method for impact resistance
of collection device
Annex G (normative) - Test method for determination of
flow rate through catheter
Annex H (informative) - Test method for retention strength
Annex I (normative) - Test method for determining
balloon security
Annex J (normative) - Test method for determining
inflation lumen leakage and/or function
and/or balloon deflation (catheter with
compliant balloon)
Annex K (normative) - Test method for determining
balloon size and deflation reliability
(catheter with non-compliant balloon)
Annex L (normative) - Test method for determining
inflated balloon resistance to traction
Annex M (normative) - Test method for resistance to
leakage during aspiration or vacuum
Bibliography