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I.S. EN 1616:1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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

Available format(s)

Hardcopy , PDF

Superseded date

23-07-2013

Superseded by

I.S. EN ISO 20696:2018

Language(s)

English

Published date

01-01-1997

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.

€53.00
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Foreword
1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Symbols and labelling
Annex A (normative) Test method for determining the
        strength of the catheter
Annex B (normative) Test method for determining the
        security of the drainage funnel
Annex C Test method for determination balloon security
Annex D (normative) Test method for determining inflation
        lumen leakage and/or function and/or balloon deflation
Annex E (informative) Bibliography

Covers requirements for sterile, single-use urethral catheters, with and without balloons.

DocumentType
Standard
Pages
29
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements

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