Dentistry - Sterile injection needles for single use (ISO 7885:2010)

ISO 7885:2010 gives dimensional and performance requirements for sterile injection needles for single use which are used in dental cartridge syringes complying with ISO 9997 for injection of dental local anaesthetics. It further specifies requirements with respect to their packaging, labelling and colour coding. It does not cover needles for special applications or techniques.
Only the materials used for the construction of the needle tubing are specified.

Zahnheilkunde -Sterile Injektionskanülen zum Einmalgebrauch (ISO 7885:2010)

In dieser Internationalen Norm werden maßliche und funktionelle Anforderungen an sterile Injektionskanülen
zum Einmalgebrauch, die in zahnärztlichen Ampullenspritzen, die ISO 9997 zur Injektion von zahnärztlichen
Lokalanästhetika entsprechen, festgelegt. Diese Norm beschreibt auch Anforderungen an die Verpackung,
Kennzeichnung und Farbcodierung.
Nur die Werkstoffe, die zur Herstellung des Kanülenrohrs verwendet werden, sind festgelegt.

Médecine bucco-dentaire - Aiguilles stériles pour injection, non réutilisables (ISO 7885:2010)

L'ISO 7885:2010 spécifie les exigences relatives aux dimensions et aux performances des aiguilles stériles pour injection, non réutilisables, pour seringues à cartouches dentaires pour anesthésie locale par injection conformes à l'ISO 9997. De plus, elle spécifie des exigences relatives à l'emballage, à l'étiquetage et au code de couleurs. Elle ne concerne pas les aiguilles pour applications ou techniques spéciales.
Seuls les matériaux utilisés pour la réalisation du tube de l'aiguille sont spécifiés.

Zobozdravstvo - Sterilne dentalne injekcijske igle za enkratno uporabo (ISO 7885:2010)

Ta mednarodni standard podaja zahteve za mere in delovanje za sterilne injekcijske igle za enkratno uporabo, ki se uporabljajo pri dentalnih injekcijskih brizgah z vložki v skladu z ISO 9997 za injiciranje dentalnih lokalnih anestetikov. Nadalje določa zahteve v zvezi z njihovim pakiranjem, uporabo nalepk in barvnim označevanjem. Ne zajema igel za posebne uporabe ali tehnike. Določa le materiale, ki se uporabljajo pri izdelavi cevke igle.

General Information

Status
Published
Publication Date
14-Feb-2010
Technical Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Feb-2010
Completion Date
15-Feb-2010

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SLOVENSKI STANDARD
SIST EN ISO 7885:2010
01-junij-2010
1DGRPHãþD
SIST EN ISO 7885:2001
Zobozdravstvo - Sterilne dentalne injekcijske igle za enkratno uporabo (ISO
7885:2010)
Dentistry - Sterile injection needles for single use (ISO 7885:2010)
Zahnheilkunde -Sterile zahnärztliche Injektionskanülen zum Einmalgebrauch (ISO
7885:2010)

Art dentaire - Aiguilles stériles pour injection, non réutilisables (ISO 7885:2010)

Ta slovenski standard je istoveten z: EN ISO 7885:2010
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 7885:2010 en

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

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SIST EN ISO 7885:2010
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SIST EN ISO 7885:2010
EUROPEAN STANDARD
EN ISO 7885
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2010
ICS 11.060.20; 11.040.25 Supersedes EN ISO 7885:2000
English Version
Dentistry - Sterile injection needles for single use (ISO
7885:2010)

Médecine bucco-dentaire - Aiguilles stériles pour injection, Zahnheilkunde -Sterile Injektionskanülen zum

non réutilisables (ISO 7885:2010) Einmalgebrauch (ISO 7885:2010)
This European Standard was approved by CEN on 20 January 2010.

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 CEN 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 CEN Management Centre has the same status as the

official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,

Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7885:2010: E

worldwide for CEN national Members.
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SIST EN ISO 7885:2010
EN ISO 7885:2010 (E)
Contents Page

Foreword ..............................................................................................................................................................3

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SIST EN ISO 7885:2010
EN ISO 7885:2010 (E)
Foreword

This document (EN ISO 7885:2010) has been prepared by Technical Committee ISO/TC 106 "Dentistry" in

collaboration with Technical Committee Technical Committee CEN/TC 55 “Dentistry” the secretariat of which

is held by DIN.

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 August 2010, and conflicting national standards shall be withdrawn at

the latest by August 2010.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 7885:2000.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following

countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech

Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and the United Kingdom.
Endorsement notice

The text of ISO 7885:2010 has been approved by CEN as a EN ISO 7885:2010 without any modification.

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SIST EN ISO 7885:2010
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SIST EN ISO 7885:2010
INTERNATIONAL ISO
STANDARD 7885
Third edition
2010-02-15
Dentistry — Sterile injection needles for
single use
Médecine bucco-dentaire — Aiguilles stériles pour injection, non
réutilisables
Reference number
ISO 7885:2010(E)
ISO 2010
---------------------- Page: 7 ----------------------
SIST EN ISO 7885:2010
ISO 7885:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 7885:2010
ISO 7885:2010(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 2.

The main task of technical committees is to prepare International Standards. 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 document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 7885 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental

instruments.

This third edition cancels and replaces the second edition (ISO 7885:2000), which has been technically

revised as follows:
a) deletion of requirement for patency of lumen;
b) introduction of colour coding for smaller needle size 0,2;
c) updated labelling requirements.
© ISO 2010 – All rights reserved iii
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SIST EN ISO 7885:2010
ISO 7885:2010(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. (See

references [6] to [8] in Bibliography.)

Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this

International Standard but it is recommended that, in assessing possible biological hazards, reference be

made to ISO 10993-1, ISO 10993-11 and ISO 7405.
This International Standard specifies requirements for dental i
...

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