SIST EN ISO 7488:2018
(Main)Dentistry - Mixing machines for dental amalgam (ISO 7488:2018)
Dentistry - Mixing machines for dental amalgam (ISO 7488:2018)
This document specifies requirements for electrically-powered mixing machines for mixing dental
amalgam alloy, and dental mercury in capsules to produce dental amalgam.
This document specifies the test methods used to determine conformity with these requirements.
This document 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.
This document 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
SIST EN ISO 7488:2018
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
SIST EN ISO 7488:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 7488:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 7488:2018
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 7488:2018
EN ISO 7488:2018 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 7488:2018
EN ISO 7488:2018 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 7488:2018
---------------------- Page: 6 ----------------------
SIST EN ISO 7488:2018
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
---------------------- Page: 7 ----------------------
SIST EN ISO 7488:2018
ISO 7488:2018(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
---------------------- Page: 8 ----------------------
SIST EN ISO 7488:2018
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 . 8
6.6.2 Procedure . 8
6.7 Mixing time. 9
6.7.1 Apparatus . 9
6.7.2 Procedure . 9
© ISO 2018 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 7488:2018
ISO 7488:2018(E)
6.8 Coherence time . 9
6.8.1 Apparatus and materials . 9
6.8.2 Procedure . 9
6.9 Long-term test .10
7 Instructions for use .11
7.1 General .11
7.2 Identification .11
7.3 Safety .11
7.4 User maintenance .11
7.5 Other maintenance .11
7.6 Mixing-capsule requirements .11
7.7 Mixing-capsule amplitude .11
7.8 Operational limitations .12
7.8.1 Mixing machine limitations .12
7.8.2 Mass and frequency . .12
8 Packaging .12
9 Marking .12
9.1 On the mixing-machine .12
9.2 On the packaging .12
Bibliography .13
iv © ISO 2018 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 7488:2018
ISO 7488:2018(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.
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 6, Dental
equipment.
This second edition cancels and replaces the first edition (ISO 7488:1991), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— clarification of the scope;
— deletion of the classification (according to frequency);
— addition of the requirements for the maximum sound pressure level in 4.3;
— addition of measurement and test methods;
© ISO 2018 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 7488:2018
ISO 7488:2018(E)
Introduction
The mixing performance requirement in this document is based on the concept of coherence time. This
arises because it is not possible to define precisely just what constitutes a “clinically usable” mix, this
being a subjective and vague value judgment. It is to be noted that the readily identifiable stage in the
mixing process designated coherence is an intermediate stage and is an indication that satisfactory
mixing is occurring. A “clinically usable” amalgam mix or other material mix cannot be obtained unless
coherence is first achieved. A “clinically usable” mix generally requires mixing further to that required
for coherence.
The scope is intended in due course to include machines for mixing material other than dental amalgam,
such as cements. However, the relevant information is not yet to be available, and all mixing related
references in this document are in respect of dental amalgam. The scope will be extended to include
capsulated cements as soon as suitable data become available and consequential additions will be
included in the requirements and test methods.
vi © ISO 2018 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 7488:2018
INTERNATIONAL STANDARD ISO 7488:2018(E)
Dentistry — Mixing machines for dental amalgam
1 Scope
This document specifies requirements for electrically-powered mixing machines for mixing dental
amalgam alloy, and dental mercury in capsules to produce dental amalgam.
This document specifies the test methods used to determine conformity with these requirements.
This document 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.
This document 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.
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
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 61671-1:2013, 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.
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
coherence
condition of the powder and liquid having been combined into a single mass
Note 1 to entry: Small cracks or a dry-looking surface do not detract from coherence.
3.2
coherence time
time taken for mixing all powder and liquid to achieve coherence
Note 1 to entry: The mix produced for the purposes of this definition is not necessarily mixed to the degree
necessary for clinical use.
© ISO 2018 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 7488:2018
ISO 7488:2018(E)
3.3
length to amplitude ratio
ratio of mixing-capsule working length (3.5) to mixing-capsule amplitude (3.4) of its motion
Note 1 to entry: Length to amplitude ratio is the principal (non-monotonic) determinant of the efficiency of the
mixing process.
3.4
mixing-capsule amplitude
range of movement of the midpoint of the mixing capsule while running measured in the direction of
the mixing-capsule working length (3.5)
3.5
mixing-capsule working length
maximum internal dimension of the mixing capsule lying parallel to the direction of the oscillatory motion
3.6
mixing machine for dental amalgam
electrically-powered devices for mixing by an oscillating action dental amalgam alloy and dental
mercury in capsules to produce dental amalgam
3.7
power rating
cube of oscillation frequency, expressed in hertz, multiplied by the square of the mixing-capsule
amplitude (3.4), expressed in metres
Note 1 to entry: Power rating is proportional to the maximum power available for the mixing process, but is not
in itself a measure or determinant of efficiency or efficacy.
Note 2 to entry: See Formula (1). Power rating is expressed in mW/g.
4 Requirements
4.1 Safety
4.1.1 Electrical
The mixing machine for dental amalgam shall be in accordance with the relevant clauses of IEC 60601-1.
4.1.2 Mechanical
The mixing machine for dental amalgam shall have an enclosure that will contain a mixing-capsule, its
contents or a machine part that may become dislodged or broken during use.
Movable components with which the user may normally be expected to come into contact shall be free
from rough or sharp edges and corners.
Test in accordance with 6.2.
4.2 Stability
The mixing machine for dental amalgam shall not visibly move across the glass surface while running
for the maximum running duration, t (6.1.5), using the maximum charge mass, m (6.1.4) at any
max max
frequency setting.
Test in accordance with 6.1 and 6.2.
2 © ISO 2018 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 7488:2018
ISO 7488:2018(E)
4.3 Sound pressure
The acoustic power output of the mixing machine for dental amalgam shall not exceed 70 dB(A).
Test in accordance with 6.3.
4.4 Frequency
4.4.1 General
The frequency of operation of the mixing machine shall not vary by more than 0,5 Hz at any frequency
setting during any run of duration t (6.1.5) for that setting when subjected individually to each of
max
the following:
a) supply voltage variation of ±5 % of the rated voltage, or if a supply voltage range is given, variation
of the voltage over the stated range, using the reference charge mass, m (6.1.2);
ref
b) variation of the charge mass, using the minimum and maximum charge, m (6.1.3) and m
min max
(6.1.4);
c) three immediately successive mixing operations, using the reference charge mass, m (6.1.2);
ref
d) variation of the ambient temperature over the range 18 °C to 28 °C, using the reference charge
mass, m (6.1.2).
ref
Test in accordance with 6.4.1.
4.4.2 Variable-power machines
At any frequency or power setting, variable-power machines shall operate within 5 % of the indicated
frequency, if given, with a reproducibility of ±0,5 Hz, and shall also conform to the requirements of 4.4.1
at each setting.
Test in accordance with 6.4.1.3.
4.5 Amplitude
The mixing-capsule amplitude shall remain stable to ±1 mm while the machine is running for the
maximum duration, t (6.1.5) and using the reference charge mass, m (6.1.2).
max ref
Test in accordance with 6.1 and 6.6.
4.6 Mixing time
4.6.1 Timing device
Machines shall include a timing device to allow selection and control of the duration of mixing.
4.6.2 Timing settings
The timing device may be continuously variable or p
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.