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.
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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
This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior.
| Committee |
TC 84
|
| DocumentType |
Standard
|
| Pages |
56
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO :ISO 20695
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 20697:2018 | Identical |
| EN ISO 20697:2018 | Identical |
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