Dentistry - Powder jet handpieces and powders (ISO 20608:2018)

ISO 20608:2018 specifies the general requirements, test methods, manufacturer's information, marking and packaging, independently of the design of the powder jet handpieces (see Figure 1).
ISO 20608:2018 applies to powder jet handpieces and their associated powders for use in the field of dentistry. They are used on patients to remove dental debris, discolourations and plaque and to clean and polish teeth where abrasion is a side effect.
ISO 20608:2018 is also applicable to powder jet handpieces and their associated powders that are used in dentistry for air driven abrasion, e.g. minimally invasive cavity preparation, preparation of surfaces for adhesives and for the removal of cement residues where abrasion is part of the desired outcome.
ISO 20608:2018 is not applicable for the dental units that are employed to supply the powder jet handpieces.
ISO 20608:2018 is not applicable to dental prophylaxis handpieces (contra angles), or electrically driven plaque removers (scalers) or multifunctional handpieces (syringes).

Zahnheilkunde - Pulverstrahl-Handstücke und Pulver (ISO 20608:2018)

Dieses Dokument legt die allgemeinen Anforderungen, Prüfverfahren, Herstellerangaben, Kennzeichnung und Verpackung fest, unabhängig von der Konstruktion der Pulverstrahl-Handstücke (siehe Bild 1).
Dieses Dokument gilt für Pulverstrahl Handstücke und die dazugehörigen Pulver für die Anwendung in der Zahnheilkunde. Sie werden an Patienten zum Entfernen von dentalen Ablagerungen, Verfärbungen und Belägen verwendet und zur Zahnreinigung und –politur, wobei Abrasion ein Nebeneffekt ist.
Es gilt ferner für Pulverstrahl Handstücke und die zugehörigen Pulver, die in der Zahnheilkunde für die luftgetriebene Abrasion verwendet werden, z. B. zur minimalinvasiven Kavitätenpräparation, zur Vorbereitung von Klebeflächen und zum Entfernen von Zementresten, wobei Abrasion Teil des gewünschten Ergebnisses ist.
Dieses Dokument gilt nicht für dentale Behandlungseinheiten, die zur Versorgung der Pulverstrahl Handstücke verwendet werden.
Dieses Dokument gilt nicht für dentale Prophylaxehandstücke (Kontrawinkel), oder elektrisch angetriebene Zahnsteinentferner (Scaler) oder Mehrfunktionshandstücke (Spritzen).

Médecine bucco-dentaire - Poudres et pièces à main de pulvérisation (ISO 20608:2018)

ISO 20608:2018 spécifie les exigences générales, les méthodes d'essai, les informations du fabricant, au marquage et à l'emballage, indépendamment de la conception des pièces à main de pulvérisation (voir Figure 1).
ISO 20608:2018 s'applique aux pièces à main de pulvérisation ainsi qu'aux poudres associées utilisées dans le domaine dentaire. Ces pièces et poudres sont employées sur les patients afin d'éliminer les débris dentaires, les décolorations et la plaque dentaire. Elles sont également utilisées pour le nettoyage et le polissage des dents dans les applications où les techniques d'abrasion sont contre-indiquées.
ISO 20608:2018 couvre également les pièces à main de pulvérisation et les poudres associées utilisées en médecine bucco-dentaire dans le cadre des procédures d'abrasion par air (par exemple, pour la préparation mini-invasive des cavités), de la préparation des surfaces pour l'application d'adhésifs, ainsi que de l'élimination des résidus de cément lorsque l'abrasion fait partie du résultat escompté.
ISO 20608:2018 ne s'applique pas aux unités dentaires employées pour alimenter les pièces à main de pulvérisation.
De même, il ne s'applique ni aux pièces à main de prophylaxie dentaire (contre-angles) ni aux instruments électriques d'élimination de la plaque dentaire (détartreurs) ni aux pièces à main multifonctions (seringues).

Zobozdravstvo - Ročni pripomočki in praški (ISO 20608:2018)

Ta mednarodni standard se uporablja za ročne pripomočke za poliranje s prašnim curkom na zračni pogon ter z njimi povezane praške za uporabo na področju zobozdravstva za odstranjevanje ostankov hrane, madežev in zobnih oblog pri pacientih z namenom čiščenja in poliranja zob, pri čemer je stranski učinek brušenje. Uporablja se tudi za ročne pripomočke za poliranje s prašnim curkom na zračni pogon ter z njimi povezane praške, ki se uporabljajo v zobozdravstvu za brušenje na zračni pogon, npr. minimalno invazivna priprava kavitete, priprava površin za lepila in odstranjevanje ostankov cementa, pri čemer je brušenje del želenega rezultata.  Standard opredeljuje splošne zahteve, preskusne metode, informacije proizvajalca ter označevanje in pakiranje, in sicer neodvisno od zasnove ročnega pripomočka za poliranje s prašnim curkom na zračni pogon.  Ta standard se ne uporablja za dentalne enote, ki se uporabljajo za napajanje ročnih pripomočkov za poliranje s prašnim curkom, ne glede na to, ali so dentalne enote pritrjene v tla, premične ali namizne. Ta standard se ne uporablja za ročne pripomočke za dentalno profilakso (kolenčniki), odstranjevalce zobnih oblog na zračni ali električni pogon (čistilci zobnega kamna) ali večfunkcijske ročne pripomočke (brizge).

General Information

Status
Published
Publication Date
15-May-2018
Withdrawal Date
29-Nov-2018
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-May-2018
Completion Date
16-May-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 20608:2018
01-julij-2018
=RER]GUDYVWYR5RþQLSULSRPRþNLLQSUDãNL ,62
Dentistry - Powder jet handpieces and powders (ISO 20608:2018)
Zahnheilkunde - Pulverstrahl-Handstücke und Pulver (ISO 20608:2018)
Médecine bucco-dentaire - Poudres et pièces à main de pulvérisation (ISO 20608:2018)
Ta slovenski standard je istoveten z: EN ISO 20608:2018
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 20608:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 20608:2018

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SIST EN ISO 20608:2018


EN ISO 20608
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2018
EUROPÄISCHE NORM
ICS 11.060.20
English Version

Dentistry - Powder jet handpieces and powders (ISO
20608:2018)
Médecine bucco-dentaire - Poudres et pièces à main de Zahnheilkunde - Pulverstrahl-Handstücke und Pulver
pulvérisation (ISO 20608:2018) (ISO 20608:2018)
This European Standard was approved by CEN on 22 March 2018.

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-CENELEC 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-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20608:2018 E
worldwide for CEN national Members.

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SIST EN ISO 20608:2018
EN ISO 20608:2018 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 20608:2018
EN ISO 20608:2018 (E)
European foreword
This document (EN ISO 20608:2018) 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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20608:2018 has been approved by CEN as EN ISO 20608:2018 without any modification.

3

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SIST EN ISO 20608:2018

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SIST EN ISO 20608:2018
INTERNATIONAL ISO
STANDARD 20608
First edition
2018-04
Dentistry — Powder jet handpieces
and powders
Médecine bucco-dentaire — Poudres et pièces à main de pulvérisation
Reference number
ISO 20608:2018(E)
©
ISO 2018

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SIST EN ISO 20608:2018
ISO 20608:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized other
...

SLOVENSKI STANDARD
oSIST prEN ISO 20608:2017
01-julij-2017
=RER]GUDYVWYR5RþQLSULSRPRþNLLQSUDãNL ,62',6
Dentistry - Powder jet handpieces and powders (ISO/DIS 20608:2017)
Zahnheilkunde - Luftbetriebene Pulverstrahlhandstücke und Pulver (ISO/DIS
20608:2017)
Médecine bucco-dentaire - Jet de poudre pour pièces à main (ISO/DIS 20608:2017)
Ta slovenski standard je istoveten z: prEN ISO 20608
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
oSIST prEN ISO 20608:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 20608:2017

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oSIST prEN ISO 20608:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 20608
ISO/TC 106/SC 4 Secretariat: DIN
Voting begins on: Voting terminates on:
2017-04-19 2017-07-12
Dentistry — Powder jet handpieces and powders
Médecine bucco-dentaire — Jet de poudre pour pièces à main
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 20608:2017(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2017

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oSIST prEN ISO 20608:2017
ISO/DIS 20608:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

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oSIST prEN ISO 20608:2017
ISO/DIS 20608:2017(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification of handpieces . 3
5 Requirements . 3
5.1 Powder for powder jet handpieces . 3
5.1.1 General. 3
5.1.2 Biocompatibility . 3
5.1.3 Powder substances .
...

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