I.S. EN ISO 20697:2018&LC:2018
Current
The latest, up-to-date edition.
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018, Corrected version 2018-09)
Hardcopy , PDF
English
18-01-2019
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.
Dates of withdrawal of national standards are available from NSAI.
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 connections
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 drainage catheter
Annex H (informative) Test method for retention strength
Annex I (normative) Test method for determining balloon safety
Annex J (normative) Test method for determining inflation lumen leakage and/or function
and/or balloon deflation (drainage catheter with compliant balloon)
Annex K (normative) Test method for determining balloon size and deflation reliability
(drainage 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
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