DIN EN ISO 10555-4:2013-11
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
Hardcopy , PDF
01-03-2024
German, English
01-11-2013
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National foreword
National Annex NA (informative) - Bibliography
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
| DocumentType |
Standard
|
| Pages |
21
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 10555-4:2013 | Identical |
| NF EN ISO 10555-4 : 2013 | Identical |
| NBN EN ISO 10555-4 : 2013 | Identical |
| NEN EN ISO 10555-4 : 2013 | Identical |
| NS EN ISO 10555-4 : 2013 | Identical |
| I.S. EN ISO 10555-4:2013 | Identical |
| SN EN ISO 10555-4 : 2013 | Identical |
| UNI EN ISO 10555-4 : 2013 | Identical |
| UNE-EN ISO 10555-4:2014 | Identical |
| BS EN ISO 10555-4:2013 | Identical |
| EN ISO 10555-4:2013 | Identical |
| ONORM EN ISO 10555-4 : 2013 | Identical |
| BWB TL 6515-0166 : 1ED 2007 | SAFETY 4 CATHETER 0.90 X 25MM, 22G, BLUE |
| BWB TL 6515-0170 : 1ED 2007 | STYLET FOR SAFETY 4 CATHETER 16G, GREY |
| DIN EN ISO 11070:2015-03 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014) |
| BWB TL 6515-0164 : 1ED 2007 | SAFETY 4 CATHETER 1.70 X 50MM, 16G, GREY |
| BWB TL 6515-0172 : 1ED 2007 | STYLET FOR SAFETY 4 CATHETER 22G, BLUE |
| BWB TL 6515-0175 : 2ED 2008 | STYLET FOR SAFETY 4 CATHETER 20G, PINK |
| DIN HDBK 227/2 : 5ED 2016 | MEDIZINISCHE EINMALPRODUKTE - BAND 2: HAEMODIALYSE, DRAINAGEN UND KATHETER, HANDSCHUHE, KONDOME SOWIE INKONTINENZ- UND OSTOMIEHILFEN |
| DIN EN ISO 25539-1:2015-07 (Draft) | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| BWB TL 6515-0168 : 1ED 2007 | SAFETY 4 CATHETER 1.10 X 33MM, 20G, PINK |
| BWB TL 6515-0167 : 1ED 2007 | SAFETY 4 CATHETER 1.50 X 45 MM, 17G, WHITE |
| 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 |
| DIN EN ISO 11070:2015-03 | STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014) |
| DIN EN ISO 25539-2:2013-05 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012) |
| DIN EN ISO 14630:2013-03 | Non-active surgical implants - General requirements (ISO 14630:2012) |
| ISO/TS 12417:2011 | Cardiovascular implants and extracorporeal systems Vascular device-drug combination products |
| DIN EN 1707:1997-01 | CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS |
| DIN EN 20594-1:1995-01 | CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS |
| 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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