I.S. EN ISO 11070:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
Hardcopy , PDF
28-01-2020
01-12-2014
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.
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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 |
42
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THE CORRECTED VERSION OF THIS STANDARD IS NOW AVAILABLE.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11070 : 2015 | Identical |
| ONORM EN ISO 11070 : 2015 | Identical |
| ISO 11070:2014 | Identical |
| UNI EN ISO 11070 : 2015 | Identical |
| BS EN ISO 11070 : 2014 | Identical |
| NS EN ISO 11070 : 2014 | Identical |
| SN EN ISO 11070 : 2015 | Identical |
| DIN EN ISO 11070:2015-03 | Identical |
| NEN EN ISO 11070 : 2014 | Identical |
| NBN EN ISO 11070 : 2014 | Identical |
| UNE-EN ISO 11070:2015 | Identical |
| DIN 13273-7:2003-08 | CATHETER FOR MEDICAL USE - PART 7: DETERMINATION OF THE X-RAY ATTENUATION OF CATHETERS - REQUIREMENTS AND TESTING |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10555-3:2013 | Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters |
| 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 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| ISO 10555-5:2013 | Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters |
| ASTM F 640 : 2012 : REDLINE | Standard Test Methods for Determining Radiopacity for Medical Use |
| ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
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