Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:1996)

Specifies requirements for sterile single-use hypodermic syringes of nominal capacity 5 ml and above, made of plastics materials and intended for use with power-driven syringe pumps. Does not apply to syringes for use with insulin, single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a doctors kid.

Sterile Einmalspritzen für medizinische Zwecke - Teil 2: Spritzen zur Verwendung mit Spritzenpumpen (ISO 7886-2:1996)

Bei Erarbeitung dieses Teils der ISO 7886 wurde schon frühzeitig erkannt, daß das absolute Leitungskriterium durch die Kombination der energiebetriebenen Spritzenpumpe mit der Spritze als Gesamtsystem erreicht wird. Dabei ist die Abhängigkeit des einen Systemteils von der Leistung des anderen von grundlegender Bedeutung. Um ein zufriedenstellendes Funktionieren des Systems sicherzustellen, ist es für den Hersteller eines dieser Teile wichtig, mit dem anderen in Verbindung zu treten, wenn Veränderungen der Konstruktion in Erwägung gezogen werden.

Seringues hypodermiques stériles, non réutilisables - Partie 2: Seringues pour pousse-seringues mûs par un moteur (ISO 7886-2:1996)

La présente partie de l'ISO 7886 fixe les prescriptions relatives aux seringues hypodermiques stériles non réutilisables, ayant une capacité égale ou supérieure à 5 ml, fabriquées en matières plastiques et destinées à être utilisées avec des pousse-seringues. La présente partie de l'ISO 7886 n'est pas applicable aux seringues pour insuline (prescrites dans l'ISO 8537), aux seringues en verre non réutilisables (prescrites dans l'ISO 595), aux seringues préremplies avec le produit d'injection par le fabricant et aux seringues fournies avec le produit d'injection sous forme de kit, destinées à être remplies par un pharmacien. Elle ne traite pas de la compatibilité avec les fluides d'injection.

Sterilne podkožne injekcijske brizge za enkratno uporabo - 2. del: Injekcijske brizge za injiciranje z injekcijskimi črpalkami (ISO 7886-2:1996)

General Information

Status
Withdrawn
Publication Date
16-Sep-1997
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
13-May-2020

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SLOVENSKI STANDARD
SIST EN ISO 7886-2:2000
01-januar-2000
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EUL]JH]DLQMLFLUDQMH]LQMHNFLMVNLPLþUSDONDPL ,62

Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven

syringe pumps (ISO 7886-2:1996)

Sterile Einmalspritzen für medizinische Zwecke - Teil 2: Spritzen zur Verwendung mit

Spritzenpumpen (ISO 7886-2:1996)

Seringues hypodermiques stériles, non réutilisables - Partie 2: Seringues pour pousse-

seringues mus par un moteur (ISO 7886-2:1996)
Ta slovenski standard je istoveten z: EN ISO 7886-2:1997
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-2:2000 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7886-2:2000
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SIST EN ISO 7886-2:2000
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SIST EN ISO 7886-2:2000
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SIST EN ISO 7886-2:2000
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SIST EN ISO 7886-2:2000
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SIST EN ISO 7886-2:2000
INTERNATIONAL
STANDARD 7886-2
First edition
1996-05-15
Sterile hypodermic syringes for Single use -
Part 2:
Syringes for use with power-driven Syringe
Pumps
Seringues hypodermiques st&iles, non r&Mkables -
Partie 2: Seringues pour pousse-seringues mOs par un moteur
Reference number
ISO 78862: 1996(E)
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SIST EN ISO 7886-2:2000
ISO 7886-2: 1996(E)
Page

1 Scope ........................................................................................

...............................................................
2 Normative references

3 Definitions ................................................................................

4 Nomenclature ...........................................................................

5 Cleanliness ...............................................................................

....................................................
Limits for acidity or alkalinity

Limits for extractable metals ....................................................

Lubricant ...................................................................................

Tolerante on graduated capacity ..............................................
........................................................................
10 Graduated scale
..........................................................................
11 Syringe design
..........................................................
12 Piston/plunger assembly

13 Nozzle .......................................................................................

.............................................................................
14 Performance

15 Packaging ................................................................................

16 Labelling ....................................................................................

Annexes
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Determination of flow characteristics
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
B Determination of compliance of Syringe

C Determination of forces required to move the Piston . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
D Rationale for flowrate characteristics

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

E Bibliography
0 ISO 1996

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced

or utilized in any form or by any means, electronie or mechanical, including photocopying and

microfilm, without Permission in writing from the publisher.
International Organization for Standardization
Case postale 56 l CH-l 211 Geneve 20 l Switzerland
Printed in Switzerland
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SIST EN ISO 7886-2:2000
@ ISO ISO 7886-2: 1996(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. Esch 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. 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 7886-2 was prepared by Technical Committee
ISO/TC 84, Medical devices for injections, Subcommittee SC 1, Syringes,
needles and intravascular ca theters for Single use.
ISO 7886 consists of the following Parts, under the general title Sterile
hypodermic syringes for Single use:
Part 1: Syringes for manual use
Part 2: Syringes for use with power-driven Syringe Pumps
Annexes A, B and C form an integral part of this part of ISO 7886. Annexes
D and E are for information only.
ISO 7886 was first published in 1984. lt was subsequently decided to
divide it into two Parts, ISO 7886-1 retaining essentially the scope of
ISO 7886:1984, and ISO 7886-2 being applicable to sterile, Single-use
syringes for use with power-driven Pumps.
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SIST EN ISO 7886-2:2000
ISO 7886-2: 1996(E) @ ISO
Introduction
1 General
In the preparation of this part of ISO 7886, it was recognized at an early
Stage that the absolute criterion of Performance is achieved by the combi-
nation of the power-driven Syringe pump and the Syringe working as a
complete System. The dependence of one element of the System on the
Performance of the other is a key factor. lt is essential for the manufac-
turer of one of these components to liaise with the manufacturer of the
other when considering changes in design, in Order to ensure satisfactory
Operation of the System. In particular, when requested by a pump manu-
facturer, a Syringe manufacturer should give information on tolerantes and
relationships between the Syringe dimensions specified in this part of
ISO 7886 and on Performance characteristics, such as forte to move the
plunger, and the variations which might be expected.
2 Design criteria
The use of syringes which were initially designed and used as manually-
operated devices in Syringe Pumps now makes it desirable to achieve
much tighter tolerantes on Syringe dimensions than normally required for
manual use.
lt is understood that the degree of investment worldwide by all Syringe
manufacturers in moulding and manufacturing equipment is such that a
Change such as modifying diameters of push-buttons or the barrel inside
diameter is largely out of resch of the Syringe industry.
Typically the hard height of a Syringe has never been regarded as a particu-
larly critical dimension. Its tolerantes are ordinarily relatively loose. The
hard-height dimension is a function of not only the total length of plunger
rod and the barrel, but also the thickness of the Piston and finger grips. The
Piston thickness, by virtue of its relatively unsophisticated manufacturing
process, tan vary considerably. Because all these components are manu-
factured in multicavity moulds from many moulds around the world, the
cumulative extreme tolerante buildup from cavity to cavity and mould to
mould and location to location is such that these previously noncritical
dimensions cannot be instantly tightened.
3 Syringe identification
lt is important that when a Syringe is fitted to a Syringe pump, the pump is
correctly programmed to perform satisfactorily with the particular Syringe
installed.
t Syringe identification
In view of the CO nsequences of incorrec by the
. an automati recognized. Methods al ready in
e need for c System is
mp, th
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SIST EN ISO 7886-2:2000
ISO 7886-2: 1996(E)
@ ISO
use, such as mechanical sensing of the Syringe outside diameter, are not
deemed feasible in the long term. This is due to overlapping ranges of
diameter of syringes produced by different manufacturers, and the lack of
relationship between the outside and inside diameters of a Syringe. lt is
also recognized that standardization of Syringe barrel diameters across the
industry is not a realistic Option.
A means by which the pump could automatically identify the Syringe model
and use this to Programme such information as barrel inside diameter,
plunger forte and occlusion alarm settings is seen as the next Stage of this
part of ISO 7886. A possible method of recognition is to identify the syr-
inge and nominal capacity by means of a marking code on the barrel,
printed at the same time as the Syringe scale, and to use this to pro-
gramme the pump automatically. lt is recommended that development of
such a System be worked on as soon as possible.
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SIST EN ISO 7886-2:2000
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SIST EN ISO 7886-2:2000
INTERNATIONAL STANDARD @ ISO ISO 7886-2: 1996(E)
Sterile hypodermic syringes for Single use -
Part 2:
Syringes for use with power-driven Syringe Pumps
ISO 3696: 1987, Water for analytical laboratory use -
1 Scope
Specifica tion and tes t me thods.
This part of ISO 7886 specifies requirements for
ISO 7864: 1993, Sterile hypodermic needles for Single
sterile Single-use hypodermic syringes of nominal
use.
capacity 5 ml and above, made of plastics materials
and intended for use with power-driven Syringe
ISO 7886-1: 1993, Sterile hypodermic syringes for
Pumps.
Single use - Part 7: Syringes for manual use.
This part of ISO 7886 does not apply to syringes for
ISO 8601: 1988, Data elements and interchange
use with insulin (specified in ISO 8537), Single-use
- Information in terchange - ßepresen ta tion
forma ts
syringes made of glass (specified in ISO 595), syr-
of dates and times.
inges prefilled with the injection by the manufacturer
and syringes supplied with the injection as a kit for
I EC 60 1-2-24: -1 1, Medial electrical equipment -
filling by a pharmaeist. lt does not address compati-
Part 2: Particular requirements for safety of infusion
bility with injection fluids.
Pumps and controllers.
2 Normative references
3 Definitions
The following Standards contain provisions which,
For the purposes of this part of ISO 7886, the defi-
through reference in this text, constitute provisions of
nitions given in ISO 7886-1 apply.
this part of ISO 7886. At the time of publication, the
editions indicated were valid. All Standards are subject
to revision, and Parties to agreements based on this
4 Nomenclature
part of ISO 7886 are encouraged to investigate the
possibility of applying the most recent editions of the
Clause 4 of ISO 7886-1:1993 shall apply.
Standards indicated below. Members of IEC and ISO
maintain registers of currently valid International
Standards.
5 Cleanliness
ISO 594-1 :1986, Conical fittings with a 6 % (Luer)
Clause 5 of ISO 7886-1 :1993 shall apply.
taper for syringes, needles and certain other medical
equipment - Part 7: General requiremen ts.
ISO 594-2:1990, Conical fittings with a 6 % (Luer)
6 Limits for acidity or alkalinity
taper for syringes, needles and certain other medical
equipmen t - Part 2: Lack fittings. Clause 6 of ISO 7886-1 :1993 shall apply.
1) To be published.
---------------------- Page: 13 ----------------------
SIST EN ISO 7886-2:2000
ISO 7886-2: 1996(E) @ ISO
Dimensions in millimetres
7 Limits for extractable metals
Clause 7 of ISO 7886-1 :1993 shall apply.
8 Lubricant
0 \
0 \
0 \
0 \
A -\
-----i----
Clause 8 of ISO 7886-1 :1993 shall apply.
--- ----
L--- ---_rr
---- ----
9 Tolerante on graduated capacity
Clause 9 of ISO 7886-1 :1993 shall apply.
I I
I I
10 Graduated scale
t I
Clause 10 of ISO 7886-1 :1993 shall apply.
I I
I I
11 Syringe design
1 @G ;
I I
Critical dimensions for the fit of the Syringe in a syr-
inge pump shall be designated as shown in figure 1
and shall be as given in table 1.
All other dimensional and design requirements shall
be as specified in ISO 7886-1.
The push-button should be of such a design as to
inhibit neither the fit in a Syringe pump driver mech-
anism designed to accept a flat push-button nor de-
tection by a built-in detection device.
A Mean inside diameter of the barrel over the swept
volume.

12 PistonJplunger assembly B Distance of the projection of the finger grips from the

outside surface of the barrel.
12.1 Design C Thickness of the finger grips.
NOTE - The finger grips should not be tapered.
The components of the Syringe should be designed in
such a manner that it is not possible easily to with-
D Distance from the surface of the finger grips nearer to
draw the plunger completely from the barrel.
the push-button to the surface of the push-button
further from the finger grips when the fiducial line of
the Piston coincides with the zero line of the scale.
Table 1
E Projection of the push-button beyond the outer dimen-
sion of the plunger ribs.
Syringe dimensions
Toler-
F Overall thickness of the push-button (including ribs,
ante on
etc., if present).
Nominal
capacity
A B C D E F
G Outside diameter of the barrel measured at a distance
min. max. min. min. max.
of 10 mm from the underside of the finger grips.
ml + % mm mm mm mm mm
H Hard height (C + D).
25andclO 1 4 3 10 2 3
2 lOandc20 1 4 3 10 2 3 J Diameter of push-button.
2 20 and < 30 1 4 3 10 2 4
K Luer leck fitting.
2 30 and < 50 0,5 4 3,5 10 2 4
2 50 0,5 4 3,5 10 2 4
Figure 1 - Designation of dimensions
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SIST EN ISO 7886-2:2000
ISO 7886-2: 1996(E)
@ ISO
Table 2
12.2 Fit of the Piston in the barrel
Maximum Variation in
Subclause 12.2 of ISO 7886-1 :1993 shall apply.
Observation-time window
flowrate
min
The fit of the Piston on the plunger should be such
that relative axial movement between the two is kept
2 +5
to a minimum in Order to reduce the possibility of
5 L-2
siphoning.
Table 3
13 Nozzle
Maximum displacement of fluid
13.1 Conical fitting
Syringe
Test pressure
nominal
kPaJ)
The male conical fitting of the Syringe nozzle shall be
capacity
in accordance with ISO 594-1 and shall have a locking
133
ml 7 40 70 90
fitting in accordance with ISO 594-2.
>5and 0,l 0,2 0,3 0,35 0,4
MOandc20
13.2 Nozzle lumen
0,4 0,6 0,8 0,9
a20andc30 0,l
0,8 0,9
230andc50 0,l 0,4 0,6
The nozzle lumen shall have a diameter of not less
0,4 1,2 1,5 1,8 2,l
a 50
than 1,2 mm.
1) 1 kPa = 7,5 mmH20 (approx.) = 0,145 Ibf/in* (p.s.i.) (approx.).
14 Performance
14.5 Plunger movement forces
14.1 Dead space
When tested as described in annex C, the maximum
forte (inclusive of any Variation) required to initiate
Subclause 14.1 of ISO 7886-1 :1993 shall apply.
movement of the Piston, the maximum sustaining
forte and the maximum allowable Variation of the
sustainina forte shall be as aiven in table 4.
14.2 Freedom from air and liquid leakage past
the Piston
Table 4
Subclause 14.2 of ISO 7886-1 :1993 shall apply.
Piston movement forces
Total
Forte to
14.3 Flow characteristics
Flowrate Sustaining Variation in
initiate
forte, max. sustaining
movement
14.3.1 When tested as described in annex A at a forte, max.
flowrate of 1 ml/h, the maximum time lag from initiat-
mI/h N') N %
ing plunger push-button movement to achieving a
20 20
1 30
steady flowrate of at least 95 % of the set flowrate
shall not exceed 10 min.
30 15 15
30 15 10
99,9
14.3.2 When tested as described in annex A, the
Overall percentage error of the flow/set delivery rate
1) 1 N = 0,224 Ibf (approx.).
shall not exceed + 2 % at both the flowrates given in
A4 . .
14.3.3 When tested as described in annex A, the
15 Packaging
maximum Variation in flowrate when measured at
two Observation-time windows shall be as shown in
15.1 Primary Container
table 2 at both the flowrates given in A.4.
Esch Syringe shall be sealed in a primary Container.
14.4 Compliance of Syringe
The materials of the Container should not have detri-
mental effects on the contents, and the material and
When tested as described in annex B, the maximum
design of the Container should be such as to ensure:
displacement of fluid shall be as given in table 3.
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SIST EN ISO 7886-2:2000
@ ISO
ISO 7886-2: 1996(E)

the maintenance of sterility of the contents under b) the model identification, if a manufacturer offers

dry, clean and adequately ventilated storage con- more than one product of the same nominal ca-

ditions; pacity.
the minimum risk of contamination of the con-
tents during opening of the Container and removal
16.2 Secondary Container
of the contents;
The secondary Container shall be marked in accord-
adequate protection of the contents during normal
ante with ISO 7886-1 and with the information listed
handling, transit and storage;
in 16.1 a) and b).
that once opened, the Container cannot be easily
resealed, and it should be obvious that the con-
tainer has been opened.
16.3 Storage Container
If a storage Container is used, subclause 16.3 of
15.2 Secondary Container
ISO 7886-1:1993 shall apply.
One or more primary conta iners shall be packaged in
The storage Container shall be marked with the
a secon dary Containe
...

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