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I.S. EN ISO 20696:2018

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Sterile urethral catheters for single use (ISO 20696:2018)

Available format(s)

Hardcopy , PDF

Superseded date

30-01-2020

Published date

22-07-2018

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.

€64.00
Excluding VAT

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

This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon. This document does not include drainage catheters covered by ISO 20697, e.g.

Committee
TC 84
DocumentType
Standard
Pages
52
ProductNote
THIS STANDARD IDENTICAL TO EN 1616:1997 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 20696:2018 Identical
UNI EN ISO 20696:2018 Identical
EN ISO 20696:2018 Identical
DIN EN ISO 20696:2018-10 Identical
PN-EN ISO 20696:2018 Identical

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