PREN ISO 10555-4 : DRAFT 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS (ISO/DIS 10555-4:2011)
01-07-2013
12-01-2013
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
Bibliography
Defines requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.
| Committee |
TC 205
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| 11/30235365 DC : 0 | Identical |
| DIN 13273-7:2003-08 | CATHETER FOR MEDICAL USE - PART 7: DETERMINATION OF THE X-RAY ATTENUATION OF CATHETERS - REQUIREMENTS AND TESTING |
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