I.S. EN 1616:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
Hardcopy , PDF
English
01-01-1997
23-07-2013
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
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Superseded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 |
| Standards | Relationship |
| BS EN 1616:1997 | Identical |
| NS EN 1616 : 97 AMD 1 99 | Identical |
| DIN EN 1616:1999-05 | Identical |
| NEN EN 1616 : 1997 AMD 1 1999 | Identical |
| NF EN 1616 : 97 AMD 1 99 | Identical |
| BS EN 1616:1997 | Equivalent |
| EN 1616:1997 | Equivalent |
| DIN EN 1616:1997-04 | Equivalent |
| UNE-EN 1616:1997 | Identical |
| 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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