BS EN ISO 11070 : 2014
Current
The latest, up-to-date edition.
STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
Hardcopy , PDF
English
01-01-2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Additional requirements for introducer needles
6 Additional requirements for introducer catheters
7 Additional requirements for sheath introducers
8 Additional requirements for guidewires
9 Additional requirements for dilators
10 Additional requirements for kits containing
combinations of devices specified in this
International Standard
Annex A (informative) - Guidance on materials
and design
Annex B (normative) - Test method for corrosion
resistance
Annex C (normative) - Method for determining
peak tensile force of introducer catheters,
sheath introducers, and dilators
Annex D (normative) - Test method for liquid
leakage from sheath introducers under
pressure
Annex E (normative) - Test method for liquid
leakage through haemostasis valves of
sheath introducers
Annex F (normative) - Test method for fracture
of guidewires
Annex G (normative) - Test method for resistance
of guidewires to damage by flexing
Annex H (normative) - Method for determining
peak tensile force of guidewires
Annex I (normative) - Determination of strength
of union of needle hub and needle
Bibliography
Describes requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555-1.
| Committee |
CH/84
|
| DevelopmentNote |
Supersedes BS 7174-4(1990) & 95/56120 DC. (11/2005) Supersedes 13/30276989 DC. (11/2014)
|
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11070 : 2015 | Identical |
| NEN EN ISO 11070 : 2014 | Identical |
| ISO 11070:2014 | Identical |
| NBN EN ISO 11070 : 2014 | Identical |
| NS EN ISO 11070 : 2014 | Identical |
| I.S. EN ISO 11070:2014 | Identical |
| DIN EN ISO 11070:2015-03 | Identical |
| EN ISO 11070:2014 | Equivalent |
| UNE-EN ISO 11070:2015 | Identical |
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