SIST EN ISO 11070:2015

Sterile, single-use intravascular catheter introducers (ISO 11070:2014)

ISO 11070:2014 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.

Sterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen Verwendung (ISO 11070:2014)

Diese Internationale Norm legt Anforderungen an Einführkanülen, Einführkatheter, Führungshülsen, Führungsdrähte und Dilatatoren fest, die steril geliefert werden und zur einmaligen Verwendung mit intravaskulären Kathetern nach ISO 10555 bestimmt sind.
ANMERKUNG   Eine Anleitung für die Werkstoffauswahl und für die Gestaltung von Zubehörinstrumenten ist in Anhang A gegeben.

Introducteurs de cathéters intravasculaires stériles, non réutilisables (ISO 11070:2014)

L'ISO 11070:2014 spécifie les exigences relatives aux aiguilles d'introducteurs, cathéters d'introducteurs et introducteurs gaines, guides et dilatateurs fournis dans des conditions stériles, non réutilisables, destinés à être utilisés avec des cathéters intravasculaires.

Vodila sterilnih žilnih katetrov za enkratno uporabo (ISO 11070:2014)

Ta mednarodni standard določa zahteve za nastavke za uvedbo igel, nastavke za uvedbo katetra, nastavke za uvedbo tulcev, vodilne žice in dilatorje, ki so dobavljeni v sterilnem stanju in namenjeni za enkratno uporabo skupaj z žilnimi katetri iz standarda ISO 10555-1. OPOMBA Navodila za material in načrtovanje dodatnih naprav so navedena v dodatku A.

General Information

• Status: Published
• Public Enquiry End Date: 29-Sep-2013
• Publication Date: 02-Feb-2015
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Jan-2015
• Due Date: 12-Mar-2015
• Completion Date: 03-Feb-2015
• Ref Project: EN ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014)

Relations

• Replaces: SIST EN ISO 11070:2000 - Sterile single-use intravascular catheter introducers (ISO 11070:1998)
• Effective Date: 01-Mar-2015
• Amended By: SIST EN ISO 11070:2015/A1:2018 - Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)
• Effective Date: 01-Sep-2018

Overview

EN ISO 11070:2014 - Sterile single-use intravascular introducers, dilators and guidewires is the European adoption of ISO 11070:2014. It specifies safety and performance requirements, test methods and manufacturer information for devices supplied sterile and intended for single use with intravascular catheters. Covered devices include introducer needles, introducer catheters, sheath introducers, guidewires and dilators. The standard replaces earlier editions and is maintained by ISO/TC 84 and CEN/TC 205.

Key topics and technical requirements

EN ISO 11070:2014 addresses both general and device-specific requirements:

• General requirements: sterilization, biocompatibility, surface condition, corrosion resistance, radio‑detectability and mandated information to be supplied by the manufacturer (labeling and instructions).
• Introducer needles & catheters: size designation, needle point and tip design, hub integrity and tests for peak tensile force where applicable.
• Sheath introducers: dimensional and size designation requirements, leakage resistance of the sheath and haemostasis valve, hub strength and peak tensile force tests.
• Guidewires: size designation, presence and testing of safety wires, fracture and flexing tests, and peak tensile force requirements to ensure mechanical integrity during intravascular use.
• Dilators: size designation, hub design and manufacturer information.
• Kits: additional requirements for kits that combine components covered by the standard.
• Test methods and annexes: normative annexes define methods for corrosion testing, tensile testing, leakage tests, fracture/flexing of guidewires and other performance verifications.

Keywords: EN ISO 11070:2014, sterile single-use intravascular introducers, guidewires, dilators, introducer catheters, medical device test methods.

Applications and who uses this standard

EN ISO 11070:2014 is used by:

• Medical device manufacturers - to design, test and declare compliance for introducers, guidewires, dilators and related kits.
• Quality and regulatory teams - to support CE marking, technical files and conformity assessment for single‑use intravascular devices.
• Test laboratories - to perform standardized tensile, leakage, corrosion, fracture and flexing tests described in the normative annexes.
• Procurement, clinical engineering and healthcare providers - to specify safe, compatible sterile single‑use components for catheterization and vascular access procedures. The standard helps reduce patient risk (device failure, contamination, embolism) by defining consistent safety, performance and labeling expectations.

Related standards

EN ISO 11070:2014 complements other medical device requirements such as standards on biocompatibility and sterile packaging/sterilization (e.g., ISO 10993 series, ISO 11607) and should be used alongside applicable regulatory guidance when preparing technical documentation and risk assessments.

For full requirements and test protocols, obtain the official standard from ISO or your national standards body.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2015
1DGRPHãþD
SIST EN ISO 11070:2000
Vodila sterilnih žilnih katetrov za enkratno uporabo (ISO 11070:2014)
Sterile, single-use intravascular catheter introducers (ISO 11070:2014)
Sterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen
Verwendung (ISO 11070:2014)
Introducteurs de cathéters intravasculaires stériles, non réutilisables (ISO 11070:2014)
Ta slovenski standard je istoveten z: EN ISO 11070:2014
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11070
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2014
ICS 11.040.25 Supersedes EN ISO 11070:1999
English Version
Sterile single-use intravascular introducers, dilators and
guidewires (ISO 11070:2014)
Introducteurs, dilatateurs et guides intravasculaires stériles Sterile Einführungsinstrumente, Dilatatoren und
non réutilisables (ISO 11070:2014) Führungsdrähte zur einmaligen Verwendung (ISO
11070:2014)
This European Standard was approved by CEN on 30 August 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11070:2014 E
worldwide for CEN national Members.

Contents page
Foreword .3
Foreword
This document (EN ISO 11070:2014) has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and catheters” in collaboration with Technical Committee CEN/TC 205
“Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by May 2015, and conflicting national standards shall be withdrawn at the
latest by May 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11070:1999.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11070:2014 has been approved by CEN as EN ISO 11070:2014 without any modification.

INTERNATIONAL ISO
STANDARD 11070
Second edition
2014-11-01
Sterile single-use intravascular
introducers, dilators and guidewires
Introducteurs, dilatateurs et guides intravasculaires stériles non
réutilisables
Reference number
ISO 11070:2014(E)
©
ISO 2014
ISO 11070:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 11070:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 5
4.1 Sterilization . 5
4.2 Biocompatibility . 5
4.3 Surface . 5
4.4 Corrosion resistance . 5
4.5 Radio-detectability . 5
4.6 Information to be supplied by the manufacturer . 5
5 Additional requirements for introducer needles . 6
5.1 General . 6
5.2 Size designation . 6
5.3 Needle point . 6
5.4 Hub . 6
5.5 Information to be supplied by the manufacturer . 6
6 Additional requirements for introducer catheters . 6
6.1 General . 6
6.2 Tip . 7
6.3 Peak tensile force . 7
6.4 Hub . 7
6.5 Size designation . 7
6.6 Information to be supplied by the manufacturer . 8
7 Additional requirements for sheath introducers . 8
7.1 General . 8
7.2 Size designation . 8
7.3 Freedom from leakage from sheath introducer . 8
7.4 Freedom from leakage through haemostasis valve . 8
7.5 Hub . 8
7.6 Peak tensile force . 8
7.7 Information to be supplied by the manufacturer . 8
8 Additional requirements for guidewires . 8
8.1 General . 8
8.2 Size designation . 9
8.3 Safety wire . 9
8.4 Fracture test . 9
8.5 Flexing test . 9
8.6 Peak tensile force of guidewire . 9
8.7 Information to be supplied by the manufacturer .10
9 Additional requirements for dilators .10
9.1 General .10
9.2 Size designation .10
9.3 Hub .10
9.4 Information to be supplied by the manufacturer .10
10 Additional requirements for kits containing combinations of devices specified in
this International Standard .10
Annex A (informative) Guidance on materials and design .12
ISO 11070:2014(E)
Annex B (normative) Test method for corrosion resistance .13
Annex C (normative) Method for determining peak tensile force of introducer catheters,
sheath introducers, and dilators .14
Annex D (normative) Test method for liquid leakage from sheath introducers under pressure .16
Annex E (normative) Test method for liquid leakage through haemostasis valves of
sheath introducers .18
Annex F (normative) Test method for fracture of guidewires .19
Annex G (normative) Test method for resistance of guidewires to damage by flexing.21
Annex H (normative) Method for determining peak tensile force of guidewires.23
Annex I (normative) Determination of strength of union of needle hub and needle .25
Bibliography .26
iv © ISO 2014 – All rights reserved

ISO 11070:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword — Supplementary information.
The committee responsible for this document is ISO/TC 84, Devices for administration of medicinal
products and catheters.
This second edition cancels and replaces the first edition (ISO 11070:1998), which has been
technically revised.
ISO 11070:2014(E)
Introduction
The purpose of this International Standard is to
— update requirements and test methods to support the function of the guidewire, and
— update size designation.
vi © ISO 2014 – All rights reserved

INTERNATIONAL STANDARD ISO 11070:2014(E)
Sterile single-use intravascular introducers, dilators and
guidewires
1 Scope
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.
NOTE Guidance on materials and design of accessory devices is given in Annex A.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
1)
ISO 594-1 , Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment
— Part 1: General requirements
2)
ISO 594-2 , Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment
— Part 2: Lock fittings
ISO 7886-1, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 8601, Data elements and interchange formats — Information interchange — Representation of
dates and times
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE Schematic examples of the devices covered by this International Standard, with examples of
terminology, are given for information in Figure 1, Figure 2, Figure 3, and Figure 4.
3.1
coil (of a guidewire)
helically wound wire
3.2
core wire (of a guidewire)
wire used to achieve stiffness of the guidewire (3.6)
3.3
dilator
flexible, tubular device used for dilating the percutaneous opening into a blood vessel
1) Upon its publication, ISO 80369-7 will replace ISO 594-1:1986.
2) Upon its publication, ISO 80369-7 will replace ISO 594-2:1998.
ISO 11070:2014(E)
3.4
distal end
patient end
end of the device, which is inserted into the patient
3.5
effective length
length of the device that can be inserted into the body
3.6
guidewire
flexible device over which a catheter or dilator (3.3) is passed to assist in the insertion and location of
the catheter or dilator into a blood vessel
Note 1 to entry: Examples of guidewire types are shown in Figure 3.
3.7
hub
connector(s) at the proximal end of the intravascular catheter introducer, which can either be integral
with the introducer or be capable of being securely fitted to the proximal end of the introducer
3.8
introducer catheter
short, flexible tube which is introduced into a blood vessel, typically over an introducer needle, and
through which a catheter or guidewire can be introduced after removal of the introducer needle
3.9
intravascular catheter introducer
device designed to be used in conjunction with an intravascular catheter to facilitate introduction into
the vascular system
3.10
introducer needle
pointed, rigid tube through which a guidewire (3.6) or catheter can be introduced into a blood vessel
3.11
proximal end
free end
end of the device opposite the distal end (3.4)
3.12
safety wire (of a guidewire)
additional wire used to minimize the possibility of detachment of the tip
3.13
sheath introducer
flexible tube which is introduced into a blood vessel, typically over a dilator (3.3), and through which a
guidewire or catheter can be introduced after removal of the dilator
3.14
tip
extremity of the distal end (3.4) of the device
2 © ISO 2014 – All rights reserved

ISO 11070:2014(E)
a)  Introducer catheter b)  Introducer needle
Key
1 effective length
2 distal end
3 catheter
4 catheter hub (optional)
5 introducer needle tube
6 needle hub
Figure 1 — Example of an introducer catheter and an introducer needle
a) Sheath introducer
b) Dilator
c) Assembled device
Key
1 distal end 5 sidearm
2 sheath 6 sidearm connection (optional)
3 haemostasis valve (optional) 7 hub
4 stopcock with Luer fitting
Figure 2 — Example of a sheath introducer and a dilator
ISO 11070:2014(E)
a) Fixed core guidewire with safety wire
b) Movable core guidewire with safety wire
c) Movable core ‘J’ guidewire with safety wire
d) Guidewire with full length polymer jacket
e) Mandrel guidewire with distal polymer jacket
f) Mandrel guidewire with distal coils
Key
1 safety wire
2 core wire
3 spring coil
4 polymer jacket
Figure 3 — Examples of guidewires
4 © ISO 2014 – All rights reserved

ISO 11070:2014(E)
4 General requirements
4.1 Sterilization
The device shall have been sterilized by a validated method, and shall comply with 4.2 to 4.4 in the
sterile condition.
NOTE See applicable part(s) of ISO 17665, ISO 11135, and ISO 11137 for appropriate methods of sterilization.
4.2 Biocompatibility
The device shall be free from biological hazard in accordance with appropriate testing under ISO 10993-1.
4.3 Surface
When examined by normal or corrected-to-normal vision with minimum 2,5x magnification, the
external surface of the effective length of the device shall appear free from extraneous matter.
The external surface of the effective length of the device, including the distal end, shall be free from
process and surface defects, which could cause trauma to vessels during use.
If the intravascular catheter introducer is lubricated, the lubricant shall not be visible as drops of fluid
on the external surface of the effective length of the device when the device is examined under normal
or corrected-to-normal vision.
4.4 Corrosion resistance
When tested in accordance with the method given in Annex B, if metallic components of the device
show visible signs of corrosion that can affect functional performance, the level of corrosion shall be
evaluated with respect to intended use and risk assessment.
4.5 Radio-detectability
Parts of the device shall be radio-detectable if required as determined by the risk assessment.
Compliance should be demonstrated by an appropriate test method, such as ASTM F640-12 or DIN 13273-7.
4.6 Information to be supplied by the manufacturer
The manufacturer shall supply at least the information listed in a) to i). All dimensions given shall be
expressed in SI units of measurement.
Units of other measurement systems can additionally be used.
Where appropriate, ISO 15223-1 should be used.
The following are the descriptions of the device:
a) name or trade name and address of the manufacturer;
b) batch code, preceded by the word LOT, or the serial number or the appropriate symbol;
c) expiry date or use-by date expressed according to ISO 8601;
d) any special storage and/or handling conditions;
e) the word STERILE or the appropriate symbol;
f) method of sterilization;
ISO 11070:2014(E)
g) an indication that the device is for single use or the appropriate symbol;
h) any known incompatibilities with substances likely to be used with the device;
i) instructions for use and warnings, as appropriate.
5 Additional requirements for introducer needles
5.1 General
The introducer needle shall comply with Clause 4.
5.2 Size designation
The nominal size of the introducer needle shall be designated by the outside diameter, inside diameter,
and the effective length as shown in Table 1.
Table 1 — Designation of nominal size of introducer needles and introducer catheters
Dimensions in millimetres
Outside diameter Inside diameter rounded Effective length rounded
Device
...