EN ISO 7885:1998

SLOVENSKI STANDARD
SIST EN ISO 7885:2000
01-januar-2000
Sterile, single-use dental injection needles (ISO 7885:1996)
Sterile, single-use dental injection needles (ISO 7885:1996)
Sterile zahnärztliche Injektionskanülen zum Einmalgebrauch (ISO 7885:1996)
Aiguilles stériles, non réutilisables, pour injections dentaires (ISO 7885:1996)
Ta slovenski standard je istoveten z: EN ISO 7885:1998
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 7885:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7885:2000

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SIST EN ISO 7885:2000

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SIST EN ISO 7885:2000

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SIST EN ISO 7885:2000

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SIST EN ISO 7885:2000

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SIST EN ISO 7885:2000
INTERNATIONAL
STANDARD
First edition
1996-08-15
Sterile, single-use dental injection needles
Aiguilles sthiles, non r&tilisables, pour injections dentaires
Reference number
IS0 7885:1996(E)

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SIST EN ISO 7885:2000
IS0 7885: 1996(E)
Page
Contents
1 Scope .
2 Normative references .
3 Definitions .
4 Requirements of assembled needle and hub .
5 Requirements of needle tubing .
6 Requirements of the hub .
.......................................
7 Requirements of the primary container
8 Sterility .
9 Labelling .
Annex
5
A Bibliography .
0 IS0 1996
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 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii

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SIST EN ISO 7885:2000
IS0 7885:1996(E)
@ IS0
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
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. IS0
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 IS0 7885 was prepared by Technical Committee
lSO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.
Annex A of this International Standard is for information only.
III

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SIST EN ISO 7885:2000
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SIST EN ISO 7885:2000
INTERNATIONAL STANDARD o Iso IS0 7885: 1996(E)
Sterile, single-use dental injection needles
the editions indicated were valid. All standards are
1 Scope
subject to revision, and parties to agreements based
on this International Standard are encouraged to in-
This International Standard specifies dimensional and
vestigate the possibility of applying the most recent
performance requirements for sterile, single-use den-
edition of the standards indicated below. Members of
tal injection needles for dental cartridge syringes for
IEC and IS0 maintain registers of currently valid Inter-
injection of dental local anaesthetics. It does not cover
national Standards.
needles for special applications or techniques.
IS0 7000:1989, Graphical symbols for use on equip-
The materials of construction other than those of the
ment - Index and synopsis.
needle tubing are not specified.
IS0 8601: 1988, Data elements and interchange for-
NOTE 1 This International Standard is closely related to
IS0 7864 prepared by ISO/TC 84, Medical devices for in-
mats - Information interchange - Representation of
jet tions.
dates and times.
This International Standard does not specify require-
IS0 9626:1991, Stainless steel tubing for manufacture
ments for validated sterilization processes.
of medical devices.
NOTE 2 lSO/TC 198, Sterilization of health care products,
IS0 9997: 1990, Dental cartridge syringes.
is in the course of preparing International Standards for
such processes.
IS0 10993-I : -I), Biological evaluation of medical de-
vices - Part I: Evaluation and testing.
This International Standard does not specify colour
coding.
IS0 10993-I 1 :I 993, Biological evaluation of medical
devices - Part I 7: Tests for systemic toxicity.
NOTE 3 lSO/TC 106 has indicated a preference for the
adoption of IS0 6009 colour coding at first revision of the
present International Standard.
In some countries national pharmacopoeia or other
3 Definitions
legally binding regulations may take precedence over
this International Standard.
...