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

This International Standard applies to air driven powder jet handpieces and their associated powders for use in the field of dentistry on patients to remove dental debris, discolourations and plaque and to clean and polish teeths where abrasion is a side effect.
It is also applicable to air driven 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.
This standard defines the general requirements, test methods, manufacturer's information, marking and packaging, independently of the design of the air driven powder jet handpiece.
This standard is not applicable for the dental units that are employed to supply the powder jet handpieces, regardless if these dental units are floor fixed, mobile or table top units.
This standard is not applicable to dental prophylaxis handpieces (contra angles), air driven 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
Public Enquiry End Date
09-Jun-2017
Publication Date
11-Jun-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
29-May-2018
Due Date
03-Aug-2018
Completion Date
12-Jun-2018

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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 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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ISO 20608:2018(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
5.2 Powder jet handpieces . 4
5.2.1 General. 4
5.2.2 Biocompatibility of materials . 4
5.2.3 Drop test . 4
5.2.4 Noise level . 4
5.2.5 Surfaces . 4
5.2.6 Nozzle rotation . 4
5.3 Air and water supply . 4
5.3.1 Drive air . 4
5.3.2 Spray water . 5
5.4 Excessive air and water pressure . 5
5.5 Temperature . 5
5.5.1 Maximum temperature during normal use . 5
5.5.2 Applied parts not intended to supply heat to a patient . 5
5.6 Vibrations . 5
5.7 Resistance to reprocessing . 5
5.8 Leakage and/or ingress of water . 5
5.9 Operating controls . 6
5.10 Usability . 6
5.11 Connection . 6
5.11.1 General. 6
5.11.2 Connections . 6
5.12 Backflow preventer . 6
5.13 Electrical safety . 6
5.14 Test report . 7
6 Sampling . 7
7 Measurement and test methods . 7
7.1 General test conditions . 7
7.2 Visual inspection . 7
7.2.1 Visual inspection of equipment . 7
7.2.2 Visual inspection of documentation or test reports . 7
7.3 Drive air . 7
7.3.1 Apparatus . 7
7.3.2 Procedure . 7
7.4 Spray water . 7
7.4.1 Apparatus . 7
7.4.2 Procedure . 8
7.5 Air and water pressure . 8
7.5.1 Apparatus . 8
7.5.2 Procedure . 8
7.6 Connection . 8
7.6.1 Apparatus . 8
© ISO 2018 – All rights reserved iii

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7.6.2 Procedure . 8
7.7 Noise level . 8
7.7.1 Apparatus . 8
7.7.2 Test chamber . 8
7.7.3 Procedure . 8
7.8 Maximum temperature during normal use . 9
7.9 Applied parts not intended to supply heat to a patient . 9
7.10 Resistance to reprocessing . 9
7.11 Backflow preventer . 9
8 Instructions for use, maintenance and service .10
8.1 Powder jet handpieces .10
8.2 Powder .11
9 Technical description .11
9.1 Powder jet handpiece .11
9.2 Powder .11
10 Marking and labelling .11
10.1 General .11
10.2 Powder jet handpieces .12
10.3 Powders.12
11 Packaging .12
Annex A (informative) Example of a test report .13
iv © ISO 2018 – All rights reserved

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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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
© ISO 2018 – All rights reserved v

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Introduction
Powder jet handpieces have been used in applications and procedures in the field of dentistry for
many years.
Technological developments continuously create better powder jet handpieces that are easier to handle,
as well as the associated powders in use, for example for teeth cleaning. The correct combination of
these elements is very important in order to achieve a good clinical performance
vi © ISO 2018 – All rights reserved

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SIST EN ISO 20608:2018
INTERNATIONAL STANDARD ISO 20608:2018(E)
Dentistry — Powder jet handpieces and powders
1 Scope
This document specifies the general requirements, test methods, manufacturer's information, marking
and packaging, independently of the design of the powder jet handpieces (see Figure 1).
This document 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.
It 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.
This document is not applicable for the dental units that are employed to supply the powder jet
handpieces.
This document is not applicable to dental prophylaxis handpieces (contra angles), or electrically driven
plaque removers (scalers) or multifunctional handpieces (syringes).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 5349-1, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted
vibration — Part 1: General requirements
ISO 5349-2, Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted
vibration — Part 2: Practical guidance for measurement at the workplace
ISO 7494-1, Dentistry — Dental units — Part 1: General requirements and test methods
ISO 9168, Dentistry — Hose connectors for air driven dental handpieces
ISO 9687, Dentistry — Graphical symbols for dental equipment
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11014, Safety data sheet for chemical products — Content and order of sections
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 17664, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices
ISO 21531, Dentistry — Graphical symbols for dental instruments
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IEC 60601-1:2005+AMD1: 2012, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
IEC 80601-2-60:2012, Medical electrical equipment — Part 2-60: Particular requirements for basic safety
and essential performance of dental equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org ./obp
3.1
abrasion
removal of material using a powder by grinding, scouring or spraying
3.2
powder jet handpiece
dental handpiece designed to transfer powder to the patient, powered via a dental unit meeting the
requirements of ISO 7494-1 or a dedicated dental unit according to the manufacturers discretion (e.g.
table top control unit)
Key
1 powder jet handpiece
2 handpiece nozzle
3 hose connector
Figure 1 — Powder jet handpiece
3.2.1
cleaning powder jet handpiece
dental handpiece designed to transfer powder to the patient for tooth cleaning and polishing
3.2.2
abrasion powder jet handpiece
dental handpiece designed to transfer powder to the patient for abrasive dental treatment
3.3
powder
dry material consisting of fine ground biocompatible substances intended for the cleaning, and
polishing or abrasion of tooth surfaces in conjunction with a powder jet handpiece
2 © ISO 2018 – All rights reserved

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3.4
spray water
water that is used to suppress dust production and to wash away the powder
3.5
dental unit
device (stationary or non-stationary) through which electrical power and/or various fluids or gasses
are supplied to at least one or more dental handpieces and devices
[SOURCE: IEC 80601-2-60:2012,201.3.206]
3.6
dental handpiece
handheld instrument used in dentistry for use in patient treatment and connected to the dental unit
[SOURCE: IEC 80601-2-60:2012,201.3.203]
4 Classification of handpieces
Powder jet handpieces are classified into two types according to their scope of application, as given in
Table 1.
Table 1 — Powder jet handpieces and powders according to scope of application
Number Type Common used powder substances
1 Cleaning powder jet handpiece e.g. sodium hydrogen carbonate,
sodium bicarbonate, calcium
carbonate, glycine
2 Abrasion powder jet handpiece e.g. corundum
5 Requirements
5.1 Powder for powder jet handpieces
5.1.1 General
The powders used in combination with powder jet handpieces shall ensure a safe and reliable operation
and the efficacy of the system (powder and handpiece). The powders shall not present a hazard for
the patient, the user or a third party when used in accordance with the manufacturer’s instructions.
To ensure this the manufacturer shall provide suitable protection measures against aspiration or
ingestion of the powder where either would be hazardous to the patient.
IEC 62366-1 and ISO 14971 shall apply.
Test conformity in accordance with 7.2.2 and by examination of the instructions for use of the powder.
5.1.2 Biocompatibility
Powders used for powder jet handpieces shall be evaluated for biocompatibility meeting the
requirements of ISO 10993-1.
Test conformity in accordance with 7.2.2.
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5.2 Powder jet handpieces
5.2.1 General
The design of the powder jet handpieces in combination with the powder shall ensure a safe and reliable
operation. The use and handling of the powder jet handpiece in dental applications shall be easy and
comfortable for the operator.
IEC 62366-1 and ISO 14971 shall apply.
Test conformity in accordance with 7.2.2.
If powder jet handpieces are intended for maintenance on site, they shall be easy to disassemble and
assemble using either no tools, readily available tools, or special to
...

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