SIST EN ISO 7885:2001
(Main)Sterile dental injection needles for single use (ISO 7885:2000)
Sterile dental injection needles for single use (ISO 7885:2000)
Sterile zahnärztliche Injektionskanülen zum einmaligen Gebrauch (ISO 7885:2000)
In dieser Internationalen Norm werden maßliche und funktionelle Anforderungen an sterile zahnärtzliche Injektionskanülen, die zum Einmalgebrauch in der Lokalanästhesie vorgesehen sind, festgelegt. Diese Norm bezieht sich nicht auf kanülen für besondere Anwendungen oder Verfahren. Außer den Werkstoffen für das Kanülenrohr werden keine weiteren Werkstoffe festgelegt.
Aiguilles dentaires stériles pour injection, non réutilisables (ISO 7885:2000)
Sterilne dentalne injekcijske igle za enkratno uporabo (ISO 7885:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7885:2001
01-november-2001
1DGRPHãþD
SIST EN ISO 7885:2000
Sterilne dentalne injekcijske igle za enkratno uporabo (ISO 7885:2000)
Sterile dental injection needles for single use (ISO 7885:2000)
Sterile zahnärztliche Injektionskanülen zum einmaligen Gebrauch (ISO 7885:2000)
Aiguilles dentaires stériles pour injection, non réutilisables (ISO 7885:2000)
Ta slovenski standard je istoveten z: EN ISO 7885:2000
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 7885:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 7885:2001
---------------------- Page: 2 ----------------------
SIST EN ISO 7885:2001
EUROPEAN STANDARD
EN ISO 7885
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2000
ICS 11.040.20; 11.060.20 Supersedes EN ISO 7885:1998
English version
Sterile dental injection needles for single use (ISO 7885:2000)
Aiguilles dentaires stériles pour injection, non réutilisables Sterile zahnärztliche Injektionskanülen zum einmaligen
(ISO 7885:2000) Gebrauch (ISO 7885:2000)
This European Standard was approved by CEN on 15 December 2000.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2000 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7885:2000 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 7885:2001
Page 2
EN ISO 7885:2000
Foreword
Corrected 2001-04-04
The text of the International Standard ISO 7885:2000 has been prepared by Technical
Committee ISO/TC 106 "Dentistry" in collaboration with Technical Committee CEN/TC 55
"Dentistry", the secretariat of which is held by DIN.
This European Standard supersedes EN ISO 7885:1998.
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 June 2001, and conflicting national
standards shall be withdrawn at the latest by June 2001.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Endorsement notice
The text of the International Standard ISO 7885:2000 was approved by CEN as a European
Standard without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative).
---------------------- Page: 4 ----------------------
SIST EN ISO 7885:2001
Page 3
EN ISO 7885:2000
Annex ZA (normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications,
indicated by (mod.), the relevant EN/HD applies.
Publication Year Titel EN Year
ISO 6009 1992 Hypodermic needles for single use – Colour EN ISO 6009 1994
coding for identification
ISO 7864 1993 Sterile hypodermic needles for single use EN ISO 7864 1995
ISO 8601 1988 Data elements and interchange formats – EN 28601 1992
Information interchange – Representation of
dates and times (including technical
corrigendum 1:1991)
ISO 9626 1991 Stainless steel needle tubing for the EN ISO 9626 1995
manufacture of medical devices
ISO 9997 1999 Dental cartridge syringes EN ISO 9997 1999
---------------------- Page: 5 ----------------------
SIST EN ISO 7885:2001
---------------------- Page: 6 ----------------------
SIST EN ISO 7885:2001
INTERNATIONAL ISO
STANDARD 7885
Second edition
2000-12-15
Sterile dental injection needles for single
use
Aiguilles dentaires stériles pour injection, non réutilisables
Reference number
ISO 7885:2000(E)
©
ISO 2000
---------------------- Page: 7 ----------------------
SIST EN ISO 7885:2001
ISO 7885:2000(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not
be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this
file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this
area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters
were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event
that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2000
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 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 copyright@iso.ch
Web www.iso.ch
Printed in Switzerland
ii © ISO 2000 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 7885:2001
ISO 7885:2000(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
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.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 7885 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 4, Dental instruments.
This second edition cancels and replaces the first edition (ISO 7885:1996), of which it constitutes a technical
revision.
The major difference between this edition and the first edition is the introduction of colour coding in accordance with
ISO 6009.
Annex A of this International Standard is for information only.
© ISO 2000 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 7885:2001
ISO 7885:2000(E)
Introduction
This International Standard is closely related to ISO 7864. Requirements for validated sterilization processes are
described in International Standards prepared by ISO/TC 198, Sterilization of health care products.
In some countries national pharmacopoeia or other legally binding regulations may take precedence over this
International Standard.
This International Standard specifies requirements for dental injection needles with metric sizes only. However,
attention is drawn to the existence of dental injection needles with imperial threads (see annex A). Manufacturers
currently producing needles with imperial thread sizes are requested to change to ISO metric threads; the year
2005 has been set as a target date.
Specific qualitative and quantitative requirements for freedom fro
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.