EN ISO 10555-5:1997
(Main)Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:1996)
Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:1996)
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. ++ BTS3 C 003/1996 N 532(TD: 1996-07-17 !!!! , today=1996-05-20) ++ Res. TC 214(Budapest 8): TC 215 recommends a package for ++ EN ISO 10555-1 & 10555-5; DAV= DOW+6months, DOW for both= January 1998!!!
Sterile intravaskuläre Katheter zur einmaligen Verwendung - Teil 5: Periphere Katheter mit innen liegender Kanüle (ISO 10555-5:1996)
Dieser Teil der ISO 10555 legt Anforderungen für intravaskuläre periphere Katheter mit innen liegender Kanüle fest, die für den Zugang ins periphere Gefässsystem vorgesehen sind, steril geliefert werden und zur einmaligen Verwendung bestimmt sind.
Cathéters intravasculaires stériles, non réutilisables - Partie 5: Cathéters périphériques à aiguille interne (ISO 10555-5:1996)
La présente partie de l'ISO 10555 fixe les prescriptions relatives aux cathéters intravasculaires périphériques à aiguille interne, non réutilisables, conçus pour permettre l'accès au système vasculaire périphérique, fournis stériles.
NOTE 1 L'attention est attirée sur l'ISO 11070, qui fixe les prescriptions relatives aux dispositifs accessoires pour utilisation avec les cathéters intravasculaires.
Sterilni žilni katetri za enkratno uporabo - 5. del: Periferni katetri z notranjo iglo (ISO 10555-5:1996)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
Sterilni žilni katetri za enkratno uporabo - 5. del: Periferni katetri z notranjo iglo
(ISO 10555-5:1996)
Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters (ISO
10555-5:1996)
Sterile intravaskuläre Katheter zur einmaligen Verwendung - Teil 5: Periphere Katheter
mit innen liegender Kanüle (ISO 10555-5:1996)
Cathéters intravasculaires stériles, non réutilisables - Partie 5: Cathéters périphériques a
aiguille interne (ISO 10555-5:1996)
Ta slovenski standard je istoveten z: EN ISO 10555-5:1997
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.
IS0 10555=5:1996(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide fed-
eration of national standards bodies (IS0 member bodies). The work of
preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be rep-
resented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. IS0 col-
laborates closely with the International Electrotechnical Commission (IEC)
on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are cir-
culated 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 IS0 10555-5 was prepared by Technical Committee
ISO/TC 84, Medical devices for injections, Subcommittee SC 1, Syringes,
needles and intravascular catheters for single use.
IS0 10555 consists of the following parts, under the general title Sterile,
single-use intravascular catheters:
Part I: General requirements
Part 2: Angiographic catheters
Part 3: Central venous catheters
- Part 4: Balloon dilatation catheters
- Part 5: Over-needle peripheral catheters
Annexes A and B form an integral part of this part of IS0 10555.
Annexes C, D and E are for information only.
0 IS0 1996
All rights reserved. Unless otherwise specified, no part of this publication may be repro-
duced or utilized in any form or by any means, electronic or mechanical, including photo-
copying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
IS0 10555=5:1996(E)
INTERNATIONAL STANDARD @ IS0
Sterile, single-use intravascular catheters -
Part 5:
Over-needle peripheral catheters
3.1 peripheral intravascular catheter: Catheter
1 Scope
designed for the introduction or withdrawal of liquids
or devices into or from the peripheral vascular system.
This part of IS0 10555 specifies requirements for
over-the-needle peripheral intravascular catheters, in-
tended for accessing the peripheral vascular system,
3.2 needle: Assembly comprising at least a needle
supplied in the sterile condition and intended for single
tube attached to, and communicating with, a needle
use.
hub.
NOTE 1 Attention is drawn to IS0 11070, which specifies
See figure 1.
requirements for accessory devices for use with intra-
vascular catheters.
needle tube: Rigid tube with one end sharpened
3.3
to facilitate entry into body tissue.
2 Normative references
needle hub: Fitting attached to the needle tube,
3.4
providing communication with its bore.
The following standards contain provisions which,
through reference in this text, constitute provisions of
this part of IS0 10555. At the time of publication, the 3.5 vent fitting: Fixed or removable fitting per-
editions indicated were valid. All standards are subject mitting venting of air while restricting or preferably
to revision, and parties to agreements based on this preventing the escape of blood.
part of IS0 10555 are encouraged to investigate the
possibility of applying the most recent editions of the
3.6 catheter unit: Assembly comprising the cath-
standards indicated below. Members of IEC and IS0
eter tube, catheter hub and any integral fittings.
maintain registers of currently valid International Stan-
dards.
See figure 1.
IS0 594-l :I 986, Conical fittings with a 6 % (Luer)
taper for syringes, needles and certain other medical
3.7 flashback: Blood flow into the needle hub.
equipment - Part 7: General requirements.
IS0 9626: 1991 I Stainless steel needle tubing for the
manufacture of medical devices.
4 Requirements
IS0 10555-I : 1995, Sterile, single-use intravascular
catheters - Part 7: General requirements.
4.1 General
Unless otherwise specified in this part of IS0 10555,
catheters shall comply with IS0 10555-I.
3 Definitions
For the purposes of this part of IS0 10555, the defi-
4.2 Radio-detectability
nitions given in IS0 10555-I and the following defi-
It is recommended that catheters be radio-opaque.
nitions apply.
@ IS0
IS0 10555=5:1996(E)
a See 4.4.2; 0 c a c 1 mm
Effective length
1 Catheter tube
2 Catheter hub
3 Needle tube
4 Needle hub
5 Vent fitting
6 Heel of bevel
7 Catheter unit
NOTE - Other design features may include wings, injection ports integral with the catheter hub, other means of connecting to
the fluid path, protection against accidental needle stick injury, etc. The catheter tube may have a single lumen or multiple
lumens.
Figure 1 - Typical over-needle peripheral intravascular catheter
NOTE 2 At the time of publication of this part of
4.4.2 Catheter unit
IS0 10555, there is no acceptable, validated test method to
determine radio-detectability. An approved test method for
The distal end shall be tapered for ease of insertion,
producing a value of radio-detectability will be established.
and shall fit closely to the needle. When the needle is
Until that time, a manufacturer may label his product “radio-
fully inserted into the catheter unit, the catheter tube
opaque” provided he can support this claim by demonstrat-
shall neither extend beyond the heel of the needle
ing that he has an appropriate method for showing radio-
bevel nor be more than 1 mm from it (see dimension
opacity.
a in figure 1).
4.3 Multilumen catheters
4.4.3 Needle
For multilumen catheters, identification of each lumen
shall be apparent to the user.
4.4.3.1 Material
4.4 Physical requirements
The needle shall be made of a rigid material and shall
be straight and uniform in cross-section and wall
4.4.1 Colour code
thickness. If a steel tube is used, it shall comply with
IS0 9626. The fluid pathway in the needle shall be
The catheter unit shall be colour-coded in accordance
free of unintended obstructions that would prevent
with table 1 to indicate the nominal outside diameter
flashback.
of the catheter tube.
IS0 10555=5:1996(E)
Table 1 - Colour coding and corresponding sizes of catheter
Nominal outside Range of actual outside
Gauge31
Colourl ) *)
diameter of catheter tube diameter
mm mm
0,550 to 0,649 Violet
0,6
0,650 to 0,749 Yellow
0,7
0,8; 0,9 0,750to 0,949 Deep blue
1,o; I,1 0,950 to 1 ,I 49 Pink 20
1,2; I,3 1,150 to 1,349 Deep green 18
1,4; I,5 1,350to 1,549 White 17
1,550 to 1,849 Medium grey 16
1,6; 1,7; I,8
1,9; 2,0; 2,l; 2,2 1,850 to 2,249 Orange 14
2,4; 2,5 2,250 to 2,549 Red 13
2,3;
2,8 2,550 to 2,849 Pale blue 12
2,6; 2,
...
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