UNI EN ISO 10555-4 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS
20-02-2024
19-09-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
Annex A (normative) - Test for balloon rated burst pressure
(RBP)
Annex B (normative) - Balloon fatigue test for freedom from
leakage and damage on inflation
Annex C (normative) - Test for balloon deflation time
Annex D (normative) - Test for balloon diameter to inflation
pressure
Annex E (informative) - Guidance on the selection of balloon
materials
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC amended by Directive 2007/47/EEC
Bibliography
Defines requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| SN EN ISO 10555-4 : 2013 | Identical |
| NF EN ISO 10555-4 : 2013 | Identical |
| I.S. EN ISO 10555-4:2013 | Identical |
| ISO 10555-4:2013 | Identical |
| BS EN ISO 10555-4:2013 | Identical |
| NS EN ISO 10555-4 : 2013 | Identical |
| UNE-EN ISO 10555-4:2014 | Identical |
| NEN EN ISO 10555-4 : 2013 | Identical |
| NBN EN ISO 10555-4 : 2013 | Identical |
| EN ISO 10555-4:2013 | Identical |
| DIN EN ISO 10555-4:2013-11 | Identical |
| ONORM EN ISO 10555-4 : 2013 | Identical |
| ISO 11070:2014 | Sterile single-use intravascular introducers, dilators and guidewires |
| ISO 25539-2:2012 | Cardiovascular implants Endovascular devices Part 2: Vascular stents |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| 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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