EN ISO 7488:2018
(Main)Dentistry - Mixing machines for dental amalgam (ISO 7488:2018)
Dentistry - Mixing machines for dental amalgam (ISO 7488:2018)
ISO 7488:2018 specifies requirements for electrically-powered mixing machines for mixing dental amalgam alloy, and dental mercury in capsules to produce dental amalgam.
ISO 7488:2018 specifies the test methods used to determine conformity with these requirements.
ISO 7488:2018 refers to those machines that mix by an oscillating action and which are sold by the manufacturer for the purpose of mixing dental amalgam whether or not they are intended for mixing any other type of product.
ISO 7488:2018 does not specify requirements for removable mixing-capsules, as are used in many machines to contain the material to be mixed, although considered as part of the machine when in use or under test.
Zahnheilkunde - Mischgeräte für zahnärztliches Amalgam (ISO 7488:2018)
In diesem Dokument werden Anforderungen an elektrisch betriebene Mischgeräte zum Mischen von dentalen Amalgamlegierungen und dentalem Quecksilber in Kapseln zur Herstellung von zahnärztlichem Amalgam festgelegt.
Dieses Dokument beschreibt die Prüfverfahren, die zur Bestimmung der Konformität mit diesen Anforderun¬gen angewandt werden.
Dieses Dokument bezieht sich auf Geräte, die durch eine oszillierende Bewegung mischen und die vom Hersteller zur Herstellung von zahnärztlichem Amalgam verkauft werden, unabhängig davon, ob sie auch zum Mischen von anderen Produkten vorgesehen sind.
In diesem Dokument werden keine Anforderungen an auswechselbare Mischkapseln festgelegt, wie sie in vielen Geräten verwendet werden, um die zu vermischenden Stoffe aufzunehmen, obwohl die Kapsel als Teil des Gerätes betrachtet wird, wenn dieses in Gebrauch ist oder geprüft wird.
Médecine bucco-dentaire - Mélangeurs pour amalgame dentaire (ISO 7488:2018)
L'ISO 7488:2018 spécifie les exigences applicables aux mélangeurs à alimentation électrique pour mélanger l'alliage d'amalgame dentaire et le mercure à usage dentaire conditionnés en capsule afin de produire un amalgame dentaire.
L'ISO 7488:2018 spécifie les méthodes utilisées pour déterminer la conformité à ces exigences.
L'ISO 7488:2018 concerne les mélangeurs à mouvement oscillatoire qui sont commercialisés par le fabricant pour mélanger l'amalgame dentaire, qu'ils soient ou non conçus pour mélanger un autre type de produit.
L'ISO 7488:2018 ne spécifie pas les exigences applicables aux capsules de mélange amovibles qui sont utilisées dans de nombreux mélangeurs pour contenir le matériau à mélanger, bien qu'elles soient considérées comme faisant partie du mélangeur lorsqu'il est utilisé ou soumis à essai.
Zobozdravstvo - Naprave za mešanje zobnega amalgama (ISO 7488:2018)
Ta dokument določa posebne zahteve za mešalne stroje na električni pogon za mešanje zobne amalgamske zlitine in živega srebra v kapsulah za izdelavo zobnega amalgama.
Ta dokument določa preskusne metode za uporabo pri ugotavljanju skladnosti s temi zahtevami. Ta dokument se nanaša na stroje za mešanje s pomočjo nihajočega premikanja, ki jih proizvajalec prodaja za mešanje zobnega amalgama, ne glede na to, ali so ti stroji namenjeni mešanju katerega koli drugega proizvoda.
Ta dokument ne določa zahtev za snemljive mešalne kapsule, ki se uporabljajo pri številnih strojih za zadrževanje materiala za mešanje, kljub temu, da med uporabo ali preskušanjem veljajo za del stroja.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2018
1DGRPHãþD
SIST EN ISO 7488:2000
Zobozdravstvo - Naprave za mešanje zobnega amalgama (ISO 7488:2018)
Dentistry - Mixing machines for dental amalgam (ISO 7488:2018)
Zahnheilkunde - Mischgeräte für zahnärztliches Amalgam (ISO 7488:2018)
Médecine bucco-dentaire - Mélangeurs pour amalgame dentaire (ISO 7488:2018)
Ta slovenski standard je istoveten z: EN ISO 7488:2018
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 7488
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 7488:1995
English Version
Dentistry - Mixing machines for dental amalgam (ISO
7488:2018)
Médecine bucco-dentaire - Mélangeurs pour amalgame Zahnheilkunde - Mischgeräte für zahnärztliches
dentaire (ISO 7488:2018) Amalgam (ISO 7488:2018)
This European Standard was approved by CEN on 15 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 7488:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 7488:2018) 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.
This document supersedes EN ISO 7488:1995.
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 7488:2018 has been approved by CEN as EN ISO 7488:2018 without any modification.
INTERNATIONAL ISO
STANDARD 7488
Second edition
2018-04
Dentistry — Mixing machines for
dental amalgam
Médecine bucco-dentaire — Mélangeurs pour amalgame dentaire
Reference number
ISO 7488:2018(E)
©
ISO 2018
ISO 7488:2018(E)
© 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
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ii © ISO 2018 – All rights reserved
ISO 7488:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Safety . 2
4.1.1 Electrical . 2
4.1.2 Mechanical . 2
4.2 Stability . 2
4.3 Sound pressure . 3
4.4 Frequency . 3
4.4.1 General. 3
4.4.2 Variable-power machines . 3
4.5 Amplitude . 3
4.6 Mixing time. 3
4.6.1 Timing device . 3
4.6.2 Timing settings . 3
4.7 Coherence time . 4
4.8 Long-term test . 4
5 Sampling . 4
5.1 Mixing machine . 4
5.2 Mixing-capsules . 4
5.2.1 General. 4
5.2.2 Mixing-capsule selection . . 4
5.3 Test components . 5
6 Measurement and test methods . 5
6.1 Test conditions . 5
6.1.1 General. 5
6.1.2 Reference charge mass, m . 5
ref
6.1.3 Minimum charge mass, m . 5
min
6.1.4 Maximum charge mass, m . 5
max
6.1.5 Maximum running duration, t . 5
max
6.1.6 Power supply conditions and apparatus . 5
6.1.7 Equipment setup . 6
6.2 Visual inspection . 6
6.3 Sound pressure . 6
6.3.1 Apparatus and setup. 6
6.3.2 Procedure . 7
6.3.3 Variable-power machines . 7
6.4 Frequency tests . 7
6.4.1 Measurement of mixing-capsule oscillation frequency. 7
6.5 Working length . 8
6.5.1 Principle . 8
6.5.2 Apparatus . 8
6.5.3 Procedure . 8
6.6 Amplitude . 8
6.6.1 Apparatus .
...
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