I.S. EN ISO 11070:2014&A1:2018&LC:2018
Current
The latest, up-to-date edition.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)
Hardcopy , PDF
English
05-10-2018
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
This International Standard specifies 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 |
TC 84
|
| DocumentType |
Standard
|
| Pages |
58
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11070:2014 | Identical |
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