I.S. EN ISO 20696:2018&LC:2018
Current
The latest, up-to-date edition.
Sterile urethral catheters for single use (ISO 20696:2018, Corrected version 2018-09)
Hardcopy , PDF
English
01-18-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 General requirements
6 Specific requirements
7 Information to be supplied by the manufacturer
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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