EN ISO 10555-4:2013
Withdrawn
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
07-10-2013
01-31-2014
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Withdrawn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 |
| 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 |
| NBN EN ISO 10555-4 : 2013 | Identical |
| UNE-EN ISO 10555-4:2014 | 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 |