SIST EN ISO 22374:2005
(Main)Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips (ISO 22374:2005)
Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips (ISO 22374:2005)
This standard specifies requirements and test methods for electrical-powered scalers and scaler tips, including piezo, ferrostrictive and magnetostricitve type ultrasonic scalers, operated as stand alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers' instructions, marking and packaging.
Electrical-powered scalers normally comprise a dental unit, a handpiece, tubing connecting the handpiece to the dental unit, and an interchangable scaler tip. The system also includes a connection to a supply of cooling liquid.
Zahnheilkunde - Zahnärztliche Handstücke - Elektrisch betriebene Scaler und Spitzen (ISO 22374:2005)
Diese Internationale Norm legt Anforderungen und Prüfverfahren für elektrisch betriebene Scaler und Spitzen fest, einschließlich Ultraschallscaler vom piezoelektrischen, ferrostriktiven und magnetostriktiven Typ, die als eigenständige Teile oder in Verbindung mit zahnärztlichen Behandlungsgeräten betrieben werden und zur Anwendung am Patienten dienen. Sie enthält auch Festlegungen für die Gebrauchsanweisung, Kennzeichnung und Verpackung.
Art dentaire - Pieces a main dentaires - Instruments pour détartrage électriques et parties actives des instruments pour détartrage (ISO 22374:2005)
L'ISO 22374:2005 spécifie les exigences et méthodes d'essai applicables aux instruments pour détartrage électriques et aux parties actives des instruments pour détartrage électriques pour le traitement des patients, y compris les instruments à ultrasons de type piézoélectrique, ferrostrictif et magnétostrictif, autonomes ou raccordés à des units dentaires. Elle contient également des spécifications sur les instructions du fabricant, le marquage et l'emballage.
Zobozdravstvo - Dentalni pripomočki - Električne priprave za umerjanje in vrste umerjanj (ISO 22374:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22374:2005
01-december-2005
=RER]GUDYVWYR'HQWDOQLSULSRPRþNL(OHNWULþQHSULSUDYH]DXPHUMDQMHLQYUVWH
XPHUMDQM ,62
Dentistry - Dental handpieces - Electrical-powered scalers and scaler tips (ISO
22374:2005)
Zahnheilkunde - Zahnärztliche Handstücke - Elektrisch betriebene Scaler und Spitzen
(ISO 22374:2005)
Art dentaire - Pieces a main dentaires - Instruments pour détartrage électriques et
parties actives des instruments pour détartrage (ISO 22374:2005)
Ta slovenski standard je istoveten z: EN ISO 22374:2005
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 22374:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22374:2005
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SIST EN ISO 22374:2005
EUROPEAN STANDARD
EN ISO 22374
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2005
ICS 11.060.25
English Version
Dentistry - Dental handpieces - Electrical-powered scalers and
scaler tips (ISO 22374:2005)
Art dentaire - Pièces à main dentaires - Instruments pour Zahnheilkunde - Zahnärztliche Handstücke - Elektrisch
détartrage électriques et parties actives des instruments betriebene Scaler und Spitzen (ISO 22374:2005)
pour détartrage (ISO 22374:2005)
This European Standard was approved by CEN on 13 August 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22374:2005: E
worldwide for CEN national Members.
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SIST EN ISO 22374:2005
EN ISO 22374:2005 (E)
Foreword
This document (EN ISO 22374:2005) 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 shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by March 2006, and conflicting national
standards shall be withdrawn at the latest by March 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 22374:2005 has been approved by CEN as EN ISO 22374:2005 without any
modifications.
2
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SIST EN ISO 22374:2005
INTERNATIONAL ISO
STANDARD 22374
First edition
2005-09-01
Dentistry — Dental handpieces —
Electrical-powered scalers and scaler tips
Art dentaire — Pièces à main dentaires — Instruments pour détartrage
électriques et parties actives des instruments pour détartrage
Reference number
ISO 22374:2005(E)
©
ISO 2005
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SIST EN ISO 22374:2005
ISO 22374:2005(E)
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© ISO 2005
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ii © ISO 2005 – All rights reserved
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SIST EN ISO 22374:2005
ISO 22374:2005(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Requirements. 2
4.1 General design of handpiece connection . 2
4.2 Scaler tip. 2
4.3 Performance. 2
4.4 Supply of cooling liquid . 3
4.5 Noise level. 3
4.6 Resistance to sterilization . 3
4.7 Energy for light source (if applicable) . 3
4.8 Electrical power supply. 3
5 Sampling. 3
6 Test methods. 3
6.1 General. 3
6.2 Visual inspection. 3
6.3 Scaler tip. 4
6.4 Frequency. 4
6.5 Amplitude, unloaded scaler tip . 5
6.6 Amplitude, loaded scaler tip. 5
6.7 Supply of cooling liquid . 6
6.8 Noise level. 6
6.9 Resistance to sterilization . 7
6.10 Energy for light supply (if applicable) . 7
7 Instructions for use, maintenance and service .8
8 Marking. 9
9 Labelling. 9
10 Packaging. 9
Annex A (informative) Performance and general design . 10
© ISO 2005 – All rights reserved iii
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SIST EN ISO 22374:2005
ISO 22374:2005(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 22374 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
iv © ISO 2005 – All rights reserved
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SIST EN ISO 22374:2005
INTERNATIONAL STANDARD ISO 22374:2005(E)
Dentistry — Dental handpieces — Electrical-powered scalers
and scaler tips
1 Scope
This International Standard specifies requirements and test methods for electrical-powered scalers and scaler
tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items
or connected to dental units, for use on patients. It also contains specifications on manufacturers’ instructions,
marking and packaging.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 7494-1, Dentistry — Dental units — Part 1: General requirements and test methods
ISO 9687, Dental equipment — Graphical symbols
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety
IEC 61012, Filters for the measurement of audible sound in the presence of ultrasound
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
electrical powered scaler
instrument with a oscillating scaler tip used in dental treatment consisting of a combination of a dental unit, a
handpiece, the tubing connecting the handpiece to the dental unit, and an interchangeable scaler tip
NOTE The system also includes a connection to a supply of cooling liquid.
© ISO 2005 – All rights reserved 1
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SIST EN ISO 22374:2005
ISO 22374:2005(E)
3.2
scaler insert system
interchangeable instrument used in an electrical-powered scaler and consisting of a working part and a
transducer for dental scaling
3.3
scaler tip
fixed or interchangeable instrument used in an electrical-powered scaler and consisting of a shaft and a
working part for dental procedures
3.4
operating area of the scaler tip
area for use, as described by the manufacturer for different scaler tips
4 Requirements
4.1 General design of handpiece connection
The configuration, dimensions and tolerances of hose connections, tested in accordance with 6.2, shall be in
accordance with the manufacturer's instructions for use.
4.2 Scaler tip
4.2.1 Extraction force
When installed in accordance with the manufacturer's instructions for use, the scaler tip, tested in accordance
with 6.3.1, shall withstand, without displacement, a minimum axial tension force of 20 N.
4.2.2 Torque (for screw-in-tips only)
The following requirement is only applicable for screw-in-tips.
When installed in accordance with the manufacturer's instructions, the scaler tip, tested in accordance with
.
6.3.2, shall withstand, without rotation displacement, a minimum torque of 200 N mm.
4.2.3 Insertion of the scaler tip
The for
...
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