SIST EN ISO 11070:2000
(Main)Sterile single-use intravascular catheter introducers (ISO 11070:1998)
Sterile single-use intravascular catheter introducers (ISO 11070:1998)
Migrated from Progress Sheet (TC Comment) (2000-07-10): This WI will probably go to a PV procedure. ++ Target dates agreed under Resolution BTS3 H C4/1992.
Einführinstrumente für intravaskuläre Katheter zur einmaligen Verwendung (ISO 11070:1998)
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 wird in Anhang A gegeben.
Introducteurs de cathéters intravasculaires stériles, non réutilisables (ISO 11070:1998)
La présente Norme internationale spécifie les prescriptions relatives aux aiguilles de l'introducteur, cathéters de l'introducteur et introducteurs gaines, guides et dilatateurs fournis dans des conditions stériles, non réutilisables, pour cathéters intravasculaires spécifiés dans l'ISO 10555.
NOTE L'annexe A donne des indications sur les matériaux et la conception des dispositifs accessoires.
Vodila sterilnih žilnih katetrov za enkratno uporabo (ISO 11070:1998)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11070:2000
01-januar-2000
Vodila sterilnih žilnih katetrov za enkratno uporabo (ISO 11070:1998)
Sterile single-use intravascular catheter introducers (ISO 11070:1998)
Einführinstrumente für intravaskuläre Katheter zur einmaligen Verwendung (ISO
11070:1998)
Introducteurs de cathéters intravasculaires stériles, non réutilisables (ISO 11070:1998)
Ta slovenski standard je istoveten z: EN ISO 11070:1999
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 11070:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11070:2000
INTERNATIONAL ISO
STANDARD 11070
First edition
1998-05-01
Sterile single-use intravascular catheter
introducers
Introducteurs de cathéters intravasculaires stériles, non réutilisables
A
Reference number
ISO 11070:1998(E)
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SIST EN ISO 11070:2000
ISO 11070:1998(E)
Page
Contents
1 Scope 1
2 Normative references 1
3 Definitions 1
4 General requirements 4
5 Additional requirements for introducer needles 5
6 Additional requirements for introducer catheters 6
7 Additional requirements for sheath introducers 7
8 Additional requirements for guide wires 8
9 Additional requirements for dilators 9
10 Additional requirements for kits containing combinations of devices
specified in this International Standard 10
Annexes
A Guidance on materials and design 11
B Test for corrosion resistance 12
C Determination of force at break of introducer catheters, sheath introducers and dilators 13
D Test for liquid leakage from sheath introducers under pressure 14
E Test for liquid leakage through haemostasis valves of sheath introducers 16
F Test for fracture of guide wires 17
G Test for resistance of guide wires to damage by flexing 19
H Test for strength of union of core wire and coil of guide wire and union of coil and safety wire 21
J Bibliography 23
© ISO 1998
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any
means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet central@iso.ch
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Printed in Switzerland
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ISO ISO 11070:1998(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.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard ISO 11070 was prepared by Technical Committee ISO/TC 84, Medical devices for injection,
Subcommittee SC 1, Syringes, needles and intravascular catheters for single use.
Annexes B, C, D, E, F, G, and H form an integral part of this International Standard. Annexes A and J are for
information only.
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SIST EN ISO 11070:2000
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INTERNATIONAL STANDARD ISO ISO 11070:1998(E)
Sterile, single-use intravascular catheter introducers
1 Scope
This International Standard specifies requirements for introducer needles, introducer catheters, sheath introducers,
guide wires and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular
catheters specified in ISO 10555.
NOTE - Guidance on materials and design of accessory devices is given in annex A.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision,
and parties to agreements based on this International Standard are encouraged to investigate the possibility of
applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of
currently valid International Standards.
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 1: General requirements.
ISO 594-2:1991, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings.
ISO 7886-1:1993, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use.
3 Definitions
For the purposes of this International Standard, the following definitions apply.
NOTE - Schematic examples of the devices covered by this International Standard, with examples of terminology, are given for
information in figures 1, 2 and 3.
3.1
coil (of a guide wire)
outer, helically wound wire
3.2
core wire (of a guide wire)
inner wire used to achieve stiffness of the guide wire
1
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3.3
dilator
flexible, tubular device used for dilating the percutaneous opening into a blood vessel
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
guide wire
spring guide
flexible device over which a catheter or dilator is passed to assist in the insertion and location of the catheter or dilator
into a blood vessel
NOTE - The guide wire may be pre-formed, such as the J-type guide wire shown in figure 3, have a fixed or movable core, and
may also be coated.
3.7
hub
connector(s) at the proximal end of the intravascular catheter introducer which may 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 guide wire 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 guide wire or catheter can be introduced into a blood vessel
3.11
proximal end
free end
end of the device opposite the distal end
3.12
safety wire (of a guide wire)
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, and through which a guide wire or catheter
can be introduced after removal of the dilator
3.14
tip
extremity of the distal end of the device
2
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a) Introducer catheter b) Introducer needle
Key
1 Effective length 4 Catheter hub (optional)
2 Distal end 5 Introducer needle tube
3 Catheter 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 4 Stopcock with Luer fitting 7 Hub
2 Sheath 5 Sidearm
3 Haemostasis valve (optional) 6 Sidearm connection (optional)
Figure 2 — Example of a sheath introducer and a dilator
3
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a) Fixed core guide wire with safety wire
b) Movable core guide wire with safety wire
c) Movable core ‘J’ guide wire with safety wire
Key
1 Safety wire
2 Core wire
3 Spring coil
Figure 3 — Examples of guide wires
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 ISO 11134, ISO 11135 and ISO 11137 for appropriate methods of sterilization.
4.2 Biocompatibility
The device shall be free from biological hazard.
NOTE - See ISO 10993-1 for selection of appropriate test methods.
4.3 Surface
When examined by normal or corrected-to-normal vision with 2,5 x magnification, the external surface of the effective
length of the device shall appear free from extraneous matter.
NOTE 1 - The external surface of the effective length of the device, including the distal end, should be free from process and
surface defects and should cause minimum trauma to vessels during use.
NOTE 2 - If the intravascular catheter introducer is lubricated, the lubricant should 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
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4.4 Corrosion resistance
When tested in accordance with the method given in annex B, metallic components of the device shall show no signs
of corrosion that affects functional performance or biocompatibility test results.
4.5 Radiodetectability
All intravascular catheter introducers, except dilators, shall be radiodetectable.
NOTE - At the time of publication of this International Standard, there was no acceptable, validated test method to
determine radiodetectability. An approved test method for producing a value of radiodetectability will be established.
Until that time, manufacturers may label their products "radio-opaque" provided they can support this claim by
demonstrating that they have an appropriate method for showing radio-opacity.
4.6 Information to be supplied by the manufacturer
The manufacturer shall supply at least the information listed in a) to j). All dimensions given shall be expressed in SI
units of measurement.
NOTE - Units of other measurement systems may additionally be used.
a) Description of the device;
b) name or trade name and address of manufacturer;
c) lot designation;
d) expiry date or use-by date;
e) any special storage and handling instructions;
f) indication of sterility;
g) method of sterilization;
h) indication for single use;
i) any known incompatibilities with substances likely to be used with the device;
j) instructions for use and warnings, as appropriate.
NOTE - The information may include an indication of radiodetectability.
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.
5
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Table 1 — Designation of nominal size of introducer needles and introducer catheters
Dimensions in millimetres
Device diameter Outside diameter rounded Inside diameter rounded Effective length
up to nearest: down to nearest: rounded to
nearest:
> 0,6 0,1 0,1 1,0
< 0,6 0,05 0,05 1,0
5.3 Needle point
The needle point shall be free from feather edges, burrs, hooks, and shall have a means of protection from damage.
5.4 Hub
5.4.1 Conical fitting
If a hub is provided, the hub shall have a female 6 % (Luer) taper conical fitting complying with ISO 594-1.
5.4.2 Strength of union of needle tube and needle hub
The union of the needle tube and the needle hub shall not be loosened by a force of 10 N for needles of nominal
outside diameter of less than 0,6 mm or of 20 N for needles of nominal outside diameter of 0,6 mm or greater.
5.5 Information to be supplied by the manufacturer
The manufacturer shall give the nominal size of the introducer needle as designated in 5.2.
6 Additional requirements for introducer catheters
6.1 General
The introducer catheter shall comply with clause 4.
6.2 Tip
If supplied with an introducer needle, when the needle is fully inserted into the introducer catheter, the catheter shall
neither extend beyond the heel of the needle bevel nor be more than 1 mm from it (see figure 4, dimension a).
NOTE - The distal end of the introducer catheter should be designed for ease of insertion and minimum trauma, and should fit
closely to the needle.
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Key
1 Heel of bevel 3 Introducer needle
2 Introducer catheter
Figure 4 — Example of an introducer needle point and an introducer catheter tip
6.3 Force at break
When tested in accordance with the method given in annex C, the minimum force at break of the introducer catheter
and the junction between the introducer catheter and the hub shall be as given in table 2.
Table 2 — Minimum force at break of introducer catheter, sheath introducer and dilator test pieces
Smallest outside diameter Minimum force at break
mm N
> 0,550 and < 0,750 3
> 0,750 and < 1,150 5
> 1,150 and < 1,850 10
15
> 1,850
6.4 Hub
If a hub is provided, the hub shall have a female 6 % (Luer) taper conical fitting complying with ISO 594-1.
6.5 Size designation
The nominal size of the introducer catheter shall be designated by the outside diameter, inside diameter and the
effective length as shown in table 1.
6.6 Information to be supplied by the manufacturer
If the introducer catheter is supplied with a needle, the manufacturer shall give a statement warning against attempting
to re-insert a partially or completely withdrawn needle.
7 Additional requirements for sheath introducers
7.1 General
Sheath introducers shall comply with clause 4.
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7.2 Size designation
The nominal size of the sheath introducer shall be designated by the following:
a) the minimum inside diameter of the sheath expressed in millimetres, rounded down to the nearest 0,1 mm;
b) the effective length expressed in millimetres or centimetres to an accuracy of ± 5 %.
7.3 Freedom from leakage from sheath introducer
1)
When tested as described in annex D, using a test pressure of 300 kPa , there shall be no leakage sufficient to form a
falling drop.
7.4 Freedom from leakage through haemostasis valve
If the sheath introducer has an integral haemostasis valve, when tested as described in annex E there shall be no
leakage past the haemostasis valve.
7.5 Hub
If a hub or hubs are provided, hubs shall have a female 6 % (Luer) taper lock fitting complying with ISO 594-2.
7.6 Force at break
When tested by the method given in annex C, the minimum force at break of the sheath introducer and the junction
between the sheath introducer and the hub shall be as given in table 2.
7.7 Information to be supplied by the manufacturer
The manufacturer shall give the nominal size of the sheath introducer as designated in 7.2.
8 Additional requirements for guide wires
8.1 General
Guide wires shall comply with clause 4.
8.2 Size designation
The nominal size of the guide wire shall be designated by the following:
a) the maximum outside diameter, expressed in millimetres, rounded up to the nearest 0,01 mm;
b) the length, expressed in millimetres or centimetres, to an accuracy of ± 5 %.
8.3 Safety wire
A safety wire shall be provided unless the core wire is attached to the tip.
1)
300 kPa = 3 bar
8
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8.4 Fracture test
When tested in accordance with annex F, the guide wire, excluding the region of fixation and the first turn, shall show
no signs of fracture, and coated guide wires shall show no flaking of the coating.
8.5 Flexing test
When tested in accordance with annex G, neither the distal end of the guide wire nor the remaining portion of the guide
wire shall show signs of defects or damage, and coated guide wires shall show no flaking of the coating.
8.6 Strength of union of safety wire and coil
When tested in accordance with annex H, the unions of the safety wire at the tip and at the proximal end shall not be
loosened.
8.7 Strength of union of core wire and coil
When tested in accordance with annex H, the unions of the core wire and the coil of the guide wire at both the tip and
the proximal end of guide wires which are not fitted with a safety wire shall not be loosened.
8.8 Information to be supplied by the manufacturer
The manufacturer shall g
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