SIST EN ISO 7494-1:2005
(Main)Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2004)
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2004)
ISO 7494-1:2004 specifies requirements and test methods for dental units, regardless of whether or not they are electrically powered.
ISO 7494-1:2004 also specifies requirements for manufacturer's instructions, marking and packaging.
Zahnheilkunde - Zahnärztliche Behandlungsgeräte - Teil 1: Allgemeine Anforderungen und Prüfverfahren (ISO 7494-1:2004)
Dieser Teil von ISO 7494 legt Anforderungen und Prüfverfahren für zahnärztliche Behandlungsgeräte fest,
unabhängig davon, ob sie elektrisch oder nicht elektrisch betrieben werden.
Er enthält auch Anforderungen an die Gebrauchsanweisung, Kennzeichnung und Verpackung.
Dieser Teil von ISO 7494 ist eine Norm aus einer Reihe von Internationalen Normen, die auf IEC 60601-1
basieren. In IEC 60601-1 (?Allgemeine Norm?) wird diese Art einer Internationalen Norm als eine ?Besondere
Norm? bezeichnet. Wie in IEC 60601-1:1988, 1.3, festgelegt, haben die Anforderungen dieses Teils von
ISO 7494 Vorrang vor denen in IEC 60601-1.
Art dentaire - Units dentaires - Partie 1: Exigences et méthodes d'essai générales (ISO 7494-1:2004)
L'ISO 7494-1:2004 spécifie les exigences et méthodes d'essai relatives aux units dentaires, indépendamment de leur construction et qu'ils soient mus électriquement ou non.
L'ISO 7494-1:2004 spécifie également des exigences relatives aux instructions du fabricant, au marquage et à l'emballage.
Zobozdravstvo – Dentalne enote – 1. del: Splošne zahteve in preskusne metode (ISO 7494-1:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7494-1:2005
01-december-2005
Zobozdravstvo – Dentalne enote – 1. del: Splošne zahteve in preskusne metode
(ISO 7494-1:2004)
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-
1:2004)
Zahnheilkunde - Zahnärztliche Behandlungsgeräte - Teil 1: Allgemeine Anforderungen
und Prüfverfahren (ISO 7494-1:2004)
Art dentaire - Units dentaires - Partie 1: Exigences et méthodes d'essai générales (ISO
7494-1:2004)
Ta slovenski standard je istoveten z: EN ISO 7494-1:2005
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
SIST EN ISO 7494-1:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7494-1:2005
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SIST EN ISO 7494-1:2005
EUROPEAN STANDARD
EN ISO 7494-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2005
ICS 11.060.20
English Version
Dentistry - Dental units - Part 1: General requirements and test
methods (ISO 7494-1:2004)
Art dentaire - Units dentaires - Partie 1: Exigences et Zahnheilkunde - Zahnärztliche Behandlungsgeräte - Teil 1:
méthodes d'essai générales (ISO 7494-1:2004) Allgemeine Anforderungen und Prüfverfahren (ISO 7494-
1:2004)
This European Standard was approved by CEN on 4 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,
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Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7494-1:2005: E
worldwide for CEN national Members.
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SIST EN ISO 7494-1:2005
EN ISO 7494-1:2005 (E)
Foreword
The text of ISO 7494-1:2004 has been prepared by Technical Committee ISO/TC 106
"Dentistry” of the International Organization for Standardization (ISO) and has been taken over
as EN ISO 7494-1:2005 by 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 February 2006, and conflicting national
standards shall be withdrawn at the latest by February 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 7494-1:2004 has been approved by CEN as EN ISO 7494-1:2005 without any
modifications.
2
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SIST EN ISO 7494-1:2005
INTERNATIONAL ISO
STANDARD 7494-1
First edition
2004-11-01
Dentistry — Dental units —
Part 1:
General requirements and test methods
Art dentaire — Units dentaires —
Partie 1: Exigences et méthodes d'essai générales
Reference number
ISO 7494-1:2004(E)
©
ISO 2004
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SIST EN ISO 7494-1:2005
ISO 7494-1:2004(E)
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ii © ISO 2004 – All rights reserved
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SIST EN ISO 7494-1:2005
ISO 7494-1:2004(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 7494-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment.
This first edition of ISO 7494-1 cancels and replaces ISO 7494:1996, of which it constitutes a minor revision.
ISO 7494 consists of the following parts, under the general title Dentistry — Dental units:
Part 1: General requirements and test methods
Part 2: Water and air supply
© ISO 2004 – All rights reserved iii
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SIST EN ISO 7494-1:2005
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SIST EN ISO 7494-1:2005
INTERNATIONAL STANDARD ISO 7494-1:2004(E)
Dentistry — Dental units —
Part 1:
General requirements and test methods
1 Scope
This part of ISO 7494 specifies requirements and test methods for dental units, regardless of whether or not
they are electrically powered.
It also specifies requirements for manufacturer's instructions, marking and packaging.
This part of ISO 7494 is one of a series of International Standards based on IEC 60601-1; in IEC 60601-1 (the
“General Standard”), this type of International Standard is referred to as a “Particular Standard”. As stated in
IEC 60601-1:1988, 1.3, the requirements of this part of ISO 7494 take precedence over those of IEC 60601-1.
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 6875, Dental patient chair
ISO 9687, Dental equipment — Graphical symbols
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1 and ISO 1942 (some of
which are repeated below for convenience) apply.
3.1
dental equipment
furniture, machines, apparatus and accessories thereto, specially manufactured and/or presented for the use
of authorized persons in the practice of dentistry and/or its associated procedures
[ISO 1942]
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SIST EN ISO 7494-1:2005
ISO 7494-1:2004(E)
3.2
dental unit
item of dental equipment consisting of an assembly of interconnected sub-units of dental equipment and
instruments providing a functional unit for dental use
[ISO 1942]
4 Classification
4.1 According to type of protection against electric shock
Dental units may be classified as follows.
a) Class I equipment
Equipment in which protection against electric shock does not rely on basic insulation only, but which
includes an additional safety precaution in such a way that means are provided for the connection of
accessible conductive parts to the protective (earth) conductor in the fixed wiring of the installation so that
accessible conductive parts cannot become live in the event of a failure of the basic insulation.
b) Class II equipment
Equipment in which protection against electric shock does not rely on basic insulation only, but in which
additional safety precautions such as double insulation or reinforced insulation are provided, there being
no provision for protective earthing or reliance upon installation conditions.
4.2 According to degree of protection against electric shock
Dental units may be grouped by type as follows.
a) Type B equipment
Class I or II equipment or equipment with an internal electrical power source providing an adequate
degree of protection against electric shock, particularly regarding
allowable leakage currents;
reliability of the protective earth connection (if present).
Type B equipment is, for example, suitable for intentional external and internal application to the patient,
excluding direct cardiac application.
b) Type BF equipment
Type B equipment with an F-type isolated (floating) applied part.
4.3 According to mode of operation
Dental units are a type of equipment with intermittent operation.
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SIST EN ISO 7494-1:2005
ISO 7494-1:2004(E)
5 Requirements and recommendations
5.1 General requirements
5.1.1 Design
5.1.1.1 Electrical requirements given in 5.3 are only applicable to electrically powered dental units. The
general requirements referred to in IEC 60601-1:1988, are applicable to non-electrical dental units as well.
If the dental unit is an integral part of the dental patient chair, then ISO 6875 applies in addition.
5.1.1.2 Dental units shall be designed, constructed and manufactured so that when properly transported,
stored, installed, used and maintained according to the manufacturer's instructions, they cause no reasonably
foreseeable danger to the patient, to the operating personnel or to the surroundings in normal use and in
single-fault condition.
These requirements cannot be objectively assessed. They are considered as fulfilled if all the tests specified
in Clause 7 are passed.
5.1.1.3 Dental units shall have the strength and rigidity necessary to resist the stresses to which they
may be subjected in normal dental practice without risk of introducing fire, electric shock or accident hazard.
These requirements cannot be objectively assessed. They are considered as fulfilled if all the tests specified
in Clause 7 are passed.
5.1.1.4 Any item of equipment recommended by the manufacturer for use in conjunction with the dental
unit shall not render the unit unsafe.
These requirements cannot be objectively assessed. They are considered as fulfilled if all the tests specified
in Clause 7 are passed.
5.1.1.5 Edges and corners of components and parts of the unit accessible to the patient or personnel
shall be finished so as to avoid injury to the patient or operator.
Compliance shall be checked by visual inspection.
5.1.1.6 Instrument hoses connected to the unit shall be disconnectable for cleaning and disinfection.
The disconnectability shall be checked by manual inspection.
5.1.2 Moving parts
Moving parts that may constitute a hazard under normal working conditions shall be covered to prevent the
risk of injury to the patient and personnel.
The distance between power-activated moving parts and counterparts accessible to the patient's and
personnel's hands and fingers shall be less than 10 mm (i.e. < 10 mm) when fully opened or a minimum of
20 mm (i.e. W 20 mm) when fully closed.
Safety features shall be provided to protect the patient and personnel from accessible power-activated moving
parts. These can include safety switches, limit switches or controls requiring continuous activation.
All electrical cables and hydraulic tubes shall be adequately protected against wear, fracture and damage due
to rubbing or strain incurred during normal operation of the unit.
Testing shall be carried out in accordance with 7.2.2.
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SIST EN ISO 7494-1:2005
ISO 7494-1:2004(E)
5.1.3 Operating controls
Controls should be located to comply with ergonomic conditions and in such a position or be of such design
that they cannot be accidentally activated.
Operating symbols in accordance with ISO 9687 shall be used where applicable.
Testing shall be carried out in accordance with 7.2.1.
5.1.4 Cleaning and disinfection
All exterior parts including instrument hoses shall be cleanable and disinfectable, without deterioration of the
surface or markings, by using agents recommended by the manufacturer.
Testing shall be carried out in accordance with 7.1.8.
5.1.5 Excessive temperatures
The requirements given in ISO 60601-1:1998, Clause 42 apply.
5.2 Mechanical requirements
5.2.1 Cuspidors
Cuspidor bowls, if provided, shall be of a material that is capable of undergoing repeated cleaning and
disinfection in accordance with instructions provided by the manufacturer without signs of deterioration.
Testing shall be carried out in accordance with 7.2.3.
5.2.2 Solids collector
Dental units shall contain a solids collector in the waste system. The solids collector should be capable of
retaining anything having a diameter of W 2 mm.
Testing shall be carried out in accordance with 7.2.1.
5.2.3 Amalgam separator device
Dental units shall be capable of being equipped with or connected to an amalgam separator device in the
waste system.
Testing shall be carried out in accordance with 7.2.1.
5.2.4 Bursting pressure
Pressure systems used in dental units shall be strong enough to withstand without bursting or leaking the
pressures specified by the manufacturer.
Testing shall be carried out in accordance with 7.2.4.
5.2.5 Pressure relief
Dental units shall be equipped with a means for safe pressure relief for all parts in which pressure might be
generated in the event of fire.
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SIST EN ISO 7494-1:2005
ISO 7494-1:2004(E)
Pressure-relief devices, fused plugs, soldered joints, non-metal tubing or other suitable pressure-relief means
or the equivalent may be employed to comply with this requirement.
Testing shall be carried out in accordance with 7.2.1.
5.2.6 Stability in normal use
The requirements given in IEC 60601-1:1988, Clause 24 apply.
5.3 Electrical requirements
5.3.1 Failsafe device
In case of a single-fault condition, e.g. failure of a limit switch, additional protective means shall be provided
such as mechanical limits to prevent injury to the patient and/or operating personnel.
The failsafe device shall also offer protection against hazards which might arise from any type of connection
with a dental patient chair.
Testing shall be carried out in accordance with 7.3.2.
5.3.2 Power input
The requirements given in IEC 60601-1:1988, Clause 7 apply.
5.3.3 Single-fault conditions
The requirements given in IEC 60601-1:1988, 3.6 apply.
5.3.4 Protection against electrical shock hazards
The requirements given in IEC 60601-1:1988, Clause 13 apply.
5.3.5 Requirements related to classification
5.3.5.1 Class I equipment
The requirements given in IEC 60601-1:1988, 14.1 apply.
5.3.5.2 Class II equipment
The requirements given in IEC 60601-1:1988, 14.2 apply.
5.3.5.3 Class I and II equipment
The requirements given in IEC 60601-1:1988, 14.4 apply, limited to classes I and II.
5.3.5.4 Types B and BF equipment
The requirements given in IEC 60601-1:1988, 14.6 apply, limited to types B and BF.
5.3.6 Limitation of voltage and/or energy
The requirements given in IEC 60601-1:1988, Clause 15 apply, with the following additions.
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SIST EN ISO 7494-1:2005
ISO 7494-1:2004(E)
Voltage shall not exceed a nominal value of 25 V a.c. or 60 V d.c. safety extra-low voltage (SELV) at a
rated supply voltage on the transformer or converter, between conductors in an earth-free circuit which is
isolated from the supply mains by a safety transformer or by a device with an equivalent separation.
Parts of the unit generating internal voltages higher than SELV shall be separated electrically from SELV.
The measures required for this, such as protective shield or insulation, are an integral part of the unit and
are tested together with this.
Parts of the unit that are fed at SELV shall not generate any internal voltage higher than SELV, unless
these voltages are separated electrically safe from SELV.
5.3.7 Enclosures and protective covers
The requirements given in IEC 60601-1:1988, Clause 16 apply.
5.3.8 Spillage and ingress of liquids
The requirements given in IEC 60601-1:1988, 44.3 and 44.6 apply.
5.3.9 Leakage
The requirements given in IEC 60601-1:1988, 44.4 apply.
5.3.10 Separation
The requirements given in IEC 60601-1:1988, Clause 17 apply, with the following addition.
Electrical non-insulated heating devices, e.g. hot-water syringes, which are in direct contact with water, as
well as electrically operated low-volt
...
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