EN ISO 10555-4:2013
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
01-31-2014
07-10-2013
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
ISO 10555-4:2013 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
Supersedes PREN ISO 10555-4. (07/2013)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DS EN ISO 10555-4 : 2013 | Identical |
| NF EN ISO 10555-4 : 2013 | Identical |
| I.S. EN ISO 10555-4:2013 | Identical |
| NEN EN ISO 10555-4 : 2013 | Identical |
| DIN EN ISO 10555-4:2013-11 | Identical |
| ISO 10555-4:2013 | Identical |
| UNI EN ISO 10555-4 : 2013 | Identical |
| SN EN ISO 10555-4 : 2013 | Identical |
| PN EN ISO 10555-4 : 2013 | Identical |
| SS-EN 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 |
| NBN EN ISO 10555-4 : 2013 | Identical |
| ONORM EN ISO 10555-4 : 2013 | Identical |
| BS EN 14299:2004 | Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents |
| DIN EN 14299:2004-08 | NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
| I.S. EN 14299:2004 | NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS |
| EN 14299:2004 | Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents |
| 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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