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I.S. EN ISO 11070:2014

I.S. EN ISO 11070:2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)

Available format(s)

Hardcopy , PDF

Superseded date

01-28-2020

Published date

12-01-2014

Publisher

National Standards Authority of Ireland

Preview

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.

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

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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